Masimo W1™ Medical Watch Receives FDA 510(k) Clearance for Over-the-Counter and Prescription Use

Masimo (NASDAQ: MASI) today announced that the Masimo W1™ medical watch has received FDA 510(k) clearance for over-the-counter (OTC) and prescription use (Rx).  Masimo W1 is the first FDA-cleared watch to provide continuous real-time oxygen saturation (SpO₂) and pulse rate (PR) for OTC and Rx use. The FDA clearance expands the indications for the Masimo W1 in the U.S. as a medical device for use by adults in hospitals, clinics, long-term care facilities, and in the home. Developed to be comfortable and lifestyle-friendly, the Masimo W1 medical watch empowers users with untethered continuous pulse oximetry as they move about their lives – no matter where they are.

The clinical power of the Masimo W1 comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates over 30 years of Signal Extraction Technology^® pulse oximetry knowledge into a single wearable module. It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals. The Masimo MW-1 module also processes these signals using Masimo’s proprietary signal processing algorithms to output high-resolution SpO₂, PR, perfusion index (Pi), and heart rate (HR) from an ECG. The continuous pulse oximetry data, under the care of a physician, can give greater visibility of changes in oxygen saturation to help patients better manage their oxygen levels daily. Managing oxygen levels can be prescribed for recovery after surgery, managing chronic breathing conditions (e.g., COPD), and for patients with congenital heart failure (CHF). 

The continuous data from the Masimo MW-1 module is displayed in real-time on the Masimo W1 watch touchscreen in an easy-to-interpret format. To help individuals identify low oxygen saturation, high pulse rate, or low pulse rate, the SpO₂ and PR values are displayed in red when they fall outside of their normal ranges. 

Joe Kiani, Founder and CEO of Masimo, said, “Clinicians at numerous prestigious institutions in Europe and the Middle East are already using Masimo W1 in a variety of innovative ways. For example, Cambridge University Hospitals in England is using it to expand their Virtual Health program to support more confident patient discharge. The Department of Anesthesiology at CHUV in Lausanne, Switzerland is using Masimo W1 on preoperative patients, to help anesthesiologists better understand the physiology and areas to improve for each patient they care for in the hospital, prior to surgery. We are excited about the hospital-to-home innovations the Masimo W1 can bring to the U.S, with this FDA clearance, and the empowerment of patients at home.”

The Masimo W1 and the integrated Masimo MW-1 module are also intended for the spot-checking of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate (PR). The Masimo W1 and the integrated Masimo MW-1 Module are indicated for adults in hospitals, clinics, long-term care facilities, and homes.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

RPVi has not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo W1™ and M-W1. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including includingMasimo W1 and M-W1, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

GE HealthCare and Masimo Collaborate to Bring Masimo SET^® Pulse Oximetry to the Wireless and Wearable GE HealthCare Portrait Mobile Platform

 

GE HealthCare (Nasdaq: GEHC) and Masimo (Nasdaq: MASI) today announced a joint agreement to integrate Masimo Signal Extraction Technology^® (SET^®) pulse oximetry into GE HealthCare’s Portrait Mobile wireless and wearable patient monitoring solution. Portrait Mobile is built as an Internet of Medical Things (IoMT) platform, using the latest cloud native technology to provide an end-to-end experience for wearable continuous monitoring. By integrating Masimo SET^®, clinicians will be able to leverage Masimo’s clinically proven Measure-through Motion and Low Perfusion^™ oxygen saturation (SpO2) measurement technology to noninvasively detect and continuously monitor changes in patient status. The agreement follows Portrait Mobile’s 510(k) clearance from the U.S. FDA in August 2023.

“Portrait Mobile is built as an open platform, with the capability to be compatible with other technologies. The ability to integrate Masimo's innovative SET^® pulse oximetry in a wearable sensor demonstrates the flexibility and scalability of our new platform while leveraging Masimo’s measurement expertise,” shared Neal Sandy, general manager of Monitoring Solutions at GE HealthCare. “Clinicians and patients will see the real benefit as Portrait Mobile enhances clinical decision-making for mobile patients and ultimately, supports earlier detection of deterioration." 

Undetected patient deterioration, particularly post-surgery, can lead to hazardous yet preventable consequences, with 30-day mortality after surgery representing the third-leading cause of death globally.¹ The uninterrupted flow of data and continuous measurement of vital signs, such as respiration rate, oxygen saturation and pulse rate, can help healthcare providers detect patient decline as it is happening, enabling timely intervention before a patient deteriorates.

GE HealthCare and Masimo have been long-term partners, delivering joint solutions for customers across the care continuum. This latest joint effort to include Masimo SET^® pulse oximetry on the Portrait Mobile platform enables real-time continuous monitoring with a personalized view of the patient’s vitals while keeping patients mobile during critical recovery periods, especially after surgery or discharge from the intensive care unit.

“We are excited to build on our collaboration with GE HealthCare by providing integrated solutions to help our customers and optimize patient care,” said Bilal Muhsin, Chief Operating Officer at Masimo. “Through our expansion into mobile, wireless technologies, we are proud to incorporate Masimo SET^® pulse oximetry into the Portrait Mobile monitoring solution.”

About Portrait Mobile
Portrait Mobile is part of GE HealthCare’s FlexAcuity monitoring solution that combines hardware and software engineered to adapt to rapidly changing patient needs and builds on a well-established history of clinical advancements. It was this deep understanding of patient needs combined with a commitment to providing caregivers with actionable insights that led GE HealthCare’s global engineers to develop this next evolution in patient monitoring technology. GE HealthCare’s technology has been recognized globally for its design, receiving the iF Design Gold Award for Product Design in 2022 for Portrait Mobile and an iF Design Award in 2023 for CARESCAPE Canvas. For more information on Portrait Mobile, please visit: www.gehealthcare.com/products/patient-monitoring/portrait-mobile.

About Masimo SET^®
Clinically proven Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies during conditions of motion and low perfusion.² Continuous monitoring using SET^® in post-surgical wards has been shown to reduce deaths due to opioid induced respiratory depression and reduce rapid response team activations and transfers back to the ICU.^3-6 Masimo SET^® has also been shown to reduce severe retinopathy of prematurity (ROP) in the NICU⁷ and improve critical congenital heart disease (CCHD) screening in newborns.⁸ Today, Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as listed in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,7 improve CCHD screening in newborns,8 and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.3-6 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

RPVi has not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

About GE Healthcare Technologies Inc.

GE HealthCare is a leading global medical technology, pharmaceutical diagnostics, and digital solutions innovator, dedicated to providing integrated solutions, services, and data analytics to make hospitals more efficient, clinicians more effective, therapies more precise, and patients healthier and happier. Serving patients and providers for more than 100 years, GE HealthCare is advancing personalized, connected, and compassionate care, while simplifying the patient’s journey across the care pathway. Together our Imaging, Ultrasound, Patient Care Solutions, and Pharmaceutical Diagnostics businesses help improve patient care from diagnosis, to therapy, to monitoring. We are an $18.3 billion business with 50,000 employees working to create a world where healthcare has no limits.

Follow us on Facebook, LinkedIn, Twitter, Instagram, and Insights for the latest news, or visit our website www.gehealthcare.com for more information.

References

1. Nepogodiev D, et al. National Institute for Health Research Global Health Research Unit on Global Surgery. Global burden of postoperative death. Lancet. 2019;393(10170):401. 
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. 
3. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287. 
4. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. 
5. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 
6. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696. 
7. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 
8. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
9. Estimate: Masimo data on file.
10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET^®, the utility of GE Portrait Mobile, and the potential benefits of Masimo’s collaboration with GE Healthcare to integrate Masimo SET^® into the GE Portrait Mobile (the “Collaboration”). These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique technologies, including Masimo SET^® and GE Portrait Mobile, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo and GE HealthCare noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that the Collaboration fails to realize the expected benefits of Masimo or GE Healthcare technologies; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 433-5847
Email: [email protected]

Media Contact
GE HealthCare
Jennifer Purdue
Phone: (267) 593-9735
Email: [email protected]

United States International Trade Commission Issues Exclusion Order for Infringing Apple Watches, Finding that Apple Violated U.S. Trade Laws

Decision Holds World’s Largest Company Accountable for Its Patent Infringement

Masimo (NASDAQ: MASI) today announced that (NASDAQ: MASI) today announced that the United States International Trade Commission (USITC) has recommended a limited exclusion order for infringing Apple Watches with light-based pulse oximetry functionality. The USITC found that Apple (NASDAQ: AAPL) violated U.S. laws by incorporating Masimo’s patented light-based pulse oximetry technology in its products. The exclusion is scheduled to go into effect after a 60-day Presidential review period.

“Today’s ruling by the USITC sends a powerful message that even the world’s largest company is not above the law,” said Joe Kiani, Founder, Chairman, and CEO of Masimo. “This important determination is a strong validation of our efforts to hold Apple accountable for unlawfully misappropriating our patented technology,” added Mr. Kiani. 

Comments from two dozen academic institutions, leading antitrust and intellectual property scholars, physicians, investors, nonprofits, and members of Congress were filed in support of the public’s interest in the exclusion order.  These comments conveyed a similar message: to protect innovation, such as Masimo’s technology, and to protect public health, it is necessary to preserve incentives to innovate and protect intellectual property and fair competition. 

In its comment submitted to the ITC, the Consumer Federation of America stated, “There is no greater offense to both the antitrust and intellectual property law than when a dominant firm infringes the patent of a smaller rival, who is an actual or potential competitor. In this case, as in the other cases involving Apple’s egregious abuse of market power, the harms far outweigh the benefit. In fact, because competition will swiftly replace any services or products that Apple is no longer able to deliver because of the remedy, there will be little harm and a great deal of benefit for consumers and the economy.” 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹¹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.12 In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

RPVi has not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to further proceedings, including the Presidential review period and any appeals. as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws. 

Media Contact
Masimo
Kristen Budreau
Phone: (949) 433-5847
Email: [email protected]

Masimo ORi^™ Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter to Provide Insight into Hyperoxia Under Supplemental Oxygen

ORi to Be Launched in the U.S. at ANESTHESIOLOGY 2023 This Weekend

Masimo (NASDAQ: MASI) today announced that ORi^™, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA. Enabled by the multi-wavelength Masimo rainbow^® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO₂) to provide increased resolution of changes in oxygenation under supplemental oxygen. With the De Novo, ORi becomes the first-of-its-kind parameter cleared by the FDA to help clinicians manage oxygen of adults undergoing surgery in perioperative hospital environments.

Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood. There is growing evidence that hyperoxia is harmful and can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.¹ Currently, clinicians take blood draws that are analyzed to determine PaO₂ levels, the partial pressure of oxygen measured by arterial blood gas devices. However, arterial blood analyses are both intermittent and delayed – leaving clinicians blind to the changes in oxygenation occurring between blood draw results. 

Masimo ORi addresses these shortcomings by providing continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range (PaO₂ > 100 and ≤ 250 mmHg). ORi is trended continuously with SpO₂ as a unit-less index between 0.00 and 1.00 to extend the visibility of the oxygenation of patients beyond SpO₂ under supplemental oxygen. By convention, SpO₂ is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered. ORi provides clinicians with additional visibility, as a complement to Masimo SET^® pulse oximetry, into when oxygenation is increased into, or decreased out of, moderate hyperoxia, in real time.

Numerous studies have demonstrated ORi’s utility. For example, in a study published in Anesthesia & Analgesia of 106 adult patients undergoing scheduled surgery, researchers found decreases in ORi “may provide advance indication of falling PaO₂ when SpO₂ is still > 98%.”² In another study published in Intensive Care Medicine, researchers found that the use of ORi monitoring to titrate oxygen rates “allowed an important reduction of the time spent with hyperoxia compared with the use of SpO₂ alone,” in a group of 150 mechanically ventilated adult patients randomized to an ORi or a control group.³

Joe Kiani, Founder and CEO of Masimo, said, “Since ORi’s availability and success outside the U.S., perioperative clinicians in the U.S. have been waiting for a way to noninvasively monitor patients under supplemental oxygen beyond the limits of SpO₂. We are thrilled that U.S. clinicians can now integrate ORi monitoring – available now on our rainbow SET^® platform – into their oxygenation monitoring practices, alongside Masimo SET^® Measure through Motion and Low Perfusion^™ pulse oximetry, and experience their combined benefits.” 

With the De Novo, Masimo is introducing a new sensor line to the market, RD rainbow^™ 4λ sensors, expanding the RD family of pulse CO-oximetry sensors, which are now available in four levels of capabilities:

• RD SET^®, which utilizes two wavelengths (2 LEDs) and features SET^® pulse oximetry.
• RD rainbow 4λ, which utilizes four wavelengths (4 LEDs) and adds the ability to measure ORi.
• RD rainbow 8λ, which utilizes eight wavelengths (8 LEDs) and enables SpHb^® (total hemoglobin) monitoring alongside ORi and other measurements.
• RD rainbow 12λ*, which utilizes twelve wavelengths (12 LEDs) and offers 12 total parameters, including SpHb, ORi and fractional oxygen saturation (SpfO₂^™) for visibility of the impact of dyshemoglobins, SpCO^® and SpMet^®, on the patient’s oxygenation.

Jesse M. Ehrenfeld, MD, President of the American Medical Association and advisor to Masimo, commented, “I can envision a number of scenarios I encounter in my daily clinical practice as an anesthesiologist where ORi would be invaluable. During patient pre-oxygenation, I often find myself unsure of the adequacy of pre-oxygenation, especially in a patient with a significant cardiopulmonary comorbidity or a patient with diminished oxygen reserve capacity. ORi would solve this problem by giving an easy-to-understand parameter that provides visibility to how oxygenation is changing during the pre-oxygenation process. Additionally, I often find that during the management of a difficult airway, it is never quite clear when to stop, re-establish mask ventilation, and allow the patient to recover. Again, ORi would be very helpful in addressing this issue as it can track the trajectory of the patient’s oxygenation status. I am delighted to see ORi receive FDA clearance. It is not often that new parameters are developed which can actually make a real impact in clinical practice.”

Richard L. Applegate II, MD, Chair of Anesthesiology at Loma Linda University Health, California, stated, “Our studies show that ORi provides advanced detection of low SpO₂ events. This additional time may allow modification of airway management, earlier calls for help, or assistance from other providers. Advanced detection of worsening oxygenation is valuable in operative and critical care settings and ORi use has the potential to provide continuous monitoring to detect changes in pulmonary function.”

Ken B. Johnson, MD, Professor of Anesthesiology, University of Utah, commented, “I have been eager for the ORi parameter to be available in the U.S. for a long time as it is a unique innovation with the potential to significantly improve patient care. Observing the ORi trend may help clinicians anticipate hemoglobin oxygen desaturations before they occur. Clinical scenarios where this technology may be useful include airway management that takes longer than expected, prompting rescue breaths before desaturation occurs, and procedural sedation with unanticipated prolonged periods of apnea that can trigger rescue maneuvers before the onset of unwanted desaturation. This index in combination with pulse oximetry shows promise in better managing adverse events related to poor oxygenation and improved patient outcomes.”

ORi is granted a De Novo by the US FDA to be used in patients undergoing surgery as an adjunct to SpO₂ for increased monitoring resolution of elevated hemoglobin oxygen saturation levels (e.g., due to administration of supplemental oxygen).

The ORi feature is indicated for the monitoring of hemoglobin oxygen saturation levels in patients 18 years and older (adults and transitional adolescents) on supplemental oxygen during no-motion conditions perioperatively in hospital environments.

*SpfO₂ and RD rainbow 12λ sensors have obtained CE Marking. Not available in the U.S.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹¹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.12 In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

RPVi has not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Mach WJ, et al. Consequences of hyperoxia and the toxicity of oxygen in the lung. Nurs Res Pract. 2011; 2011: 260482. 
2. Applegate RL 2nd, Dorotta IL, Wells B, Juma D, Applegate PM. Anesth Analg. 2016 Mar 22. [Epub ahead of print] PubMed PMID: 27007078. 
3. Lasocki S, Brochant A, Leger M, Gaillard T, Lemarié P, Gergaud S, Dupré P. Intensive Care Med. 2019 Aug 13. doi:10.1007/s00134-019-05732-9. 
4. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. 
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. 
7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696. 
9. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 
10. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
11. Estimate: Masimo data on file.
12. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo ORi^™ and RD rainbow^™ sensors. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique technologies, including including Masimo ORi and RD rainbow sensors, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws. 

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Receives EU MDR CE Mark for LiDCO^® Module for Hemodynamic Monitoring

LiDCO Offers Clinicians, for the First Time, a Board-in-Cable Solution Designed to Provide a More Complete Picture of Oxygen Delivery

Masimo (NASDAQ: MASI) today announced the CE mark, under the European Union Medical Device Regulation, for the LiDCO^® board-in-cable (BIC) module. The LiDCO BIC module is designed to connect to multi-patient monitoring platforms, like the Masimo Root^® Patient Monitoring and Connectivity Hub, to provide advanced hemodynamic monitoring. With this solution, clinicians can easily add LiDCO hemodynamic monitoring – with its one-of-a-kind versatile PulseCO^® algorithm – to their Root patient monitoring hubs. Like the PulseCO algorithm, the LiDCO module is pressure transducer agnostic, maximizing flexibility for clinicians and hospitals. For the first time, there is now a solution that can enable hemodynamic monitoring alongside other supported parameters without having a dedicated hemodynamic monitoring box. The LiDCO module supports everything from powerful guided protocols, designed to help assess fluid responsiveness, to rich trending data and notifications for beat-by-beat pressure analysis that can be displayed in the most helpful configurations for each patient on the Root monitor. Combining Masimo rainbow^® Pulse CO-Oximetry and LiDCO hemodynamic monitoring brings the potential for significant new insights into patient status.

Joe Kiani, Founder and CEO of Masimo, said, “Bringing LiDCO’s beat-to-beat advanced hemodynamic monitoring to Masimo Root opens up the possibility of  providing a more complete, continuous picture of cardiac output (CO) and oxygen delivery (DO₂). Currently, hemodynamic monitors can provide continuous analysis of blood pressure information but rely on intermittent data from other monitors for oxygenation – giving clinicians only half of the information. Using both Masimo’s breakthrough noninvasive rainbow SET^® Pulse CO-Oximetry parameters and LiDCO’s innovative PulseCO algorithm, clinicians now have the ability to view a continuous and simultaneous display of all the components that make up a patient’s oxygen delivery, DO₂ – such as cardiac output (CO), stroke volume (SV), pulse rate (PR), total hemoglobin (Masimo SpHb^®), and fractional oxygen saturation (Masimo SET^® SpO₂ adjusted for dyshemoglobins, SpCO^® and SpMet^®) – alongside an automated estimation of DO₂. These can be displayed side by side, in real time and continuously, on Root’s high-resolution screen. We are excited about what this means for surgical and critical care patients whose clinicians can finally view real-time continuous data from the breakthrough combination of LiDCO and rainbow^®, working synergistically together as an indication of continuous oxygen delivery.”

The LiDCO module is designed for efficient setup and simple, versatile operation, using a patient’s existing arterial line and blood pressure transducer to monitor a large list of advanced hemodynamic parameters using the powerful beat-by-beat PulseCO algorithm. The beat-by-beat analysis helps to provide more immediate feedback on fluid and hemodynamic status and avoid delays common with other hemodynamic monitors, which rely on assumptions about vascular compliance or detection of the dicrotic notch. Its streamlined board-in-cable design takes into account seamless compatibility with the Root monitor and other multiparameter platforms, removing the need to add a dedicated hemodynamic monitor to the already crowded OR and ICU space.

Dr. Max Jonas, Consultant in Intensive Care Medicine and Anesthesia at Southampton General Hospital in the U.K., said, “The introduction of the Masimo LiDCO Module is clinically very exciting, as it will deliver dynamic hemodynamic monitoring, with a known documented positive impact on patient outcome. The ability to provide individualized goal-directed therapy with calculated global oxygen delivery using LiDCO-derived cardiac output is clinically important. In my opinion understanding the individualized physiology of a particular patient is paramount to targeted treatments. Assessing preload, contractility and afterload using the LiDCO algorithm underpins patient management and the enhanced recovery after surgery (ERAS) process.”

Dr. Daniela Chaló, MD, PhD in Neurosciences, DESAIC, Head of Anesthesiology at Centro Hospitalar Baixo Vouga in Portugal, added, “The LiDCO monitor offers several advantages in hemodynamic monitoring. It is a plug-and-play solution, directly connected to the patient monitor or existing blood pressure transducer, without any disposables, compatible with various patient monitoring systems, helping healthcare providers to make better decisions.” Dr. Chaló continued, “The addition of LiDCO to the Root monitor – which also offers SpHb for hemoglobin monitoring and SedLine^® and O3^® for brain monitoring – means that all pertinent information can be available on one sole monitor. This is an extraordinary advancement for anesthesiology and intensive care. Root raises the standard of perioperative monitoring and is even bringing it to the artificial intelligence era. This is what we have all been waiting for.”

In clinical studies, use of LiDCO has been shown to reduce postoperative complications, costs, and even mortalities at 30 and 180 days after surgery. In a randomized, controlled trial of 743 patients undergoing major abdominal surgery, researchers found hemodynamic optimization with LiDCO led to a 20% reduction in postoperative complications and, as a result, patients monitored with LiDCO were on average $530 less expensive to treat than control patients who were not monitored.¹ In another study that compared the outcomes of 600 emergency laparotomy patients, researchers found that, following the implementation of a program including LiDCO technology, there was a significant decrease in mortality at 30 days (from 21.8 to 15.5%) and 180 days (from 29.5 to 22.2%).² 

The combination of LiDCO and Root may potentially have an even greater impact on the care paradigm. 

A parameter as a measure of continuous oxygen delivery has not received FDA clearance and is not available in the U.S. 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Pearse R et al. Effect of a perioperative, cardiac output-guided hemodynamic therapy algorithm on outcomes following major gastrointestinal surgery: a randomized clinical trial and systematic review. JAMA 2014; 311(21):2181-90. 
2. Tengberg LT et al. Multidisciplinary perioperative protocol in patients undergoing acute high-risk abdominal surgery. Br J Surg 2017; 104:463-471. 
3. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
9. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
10. Estimate: Masimo data on file.
11. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo LiDCO^®, Root^®, and rainbow SET^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including includingMasimo LiDCO, Root, and rainbow SET, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Franciscan Missionaries of Our Lady Health System and Masimo Sign Multi-year, System-wide Monitoring Agreement

Leading Louisiana and Mississippi Healthcare Provider Standardizes 10 Hospitals on Masimo SET^® and Patient SafetyNet™ to Enhance Patient Safety and Improve Patient Outcomes

Masimo (NASDAQ: MASI) and Franciscan Missionaries of Our Lady Health System (FMOLHS), a 10-hospital system headquartered in Baton Rouge and serving communities throughout Louisiana and Mississippi, have signed a multi-year agreement to implement Masimo monitoring technologies system-wide. FMOLHS hospitals are standardizing on Masimo SET^® pulse oximetry, including the use of Radius PPG^® tetherless pulse oximetry to ensure uninterrupted continuous patient monitoring even while patients are ambulating. 

In addition, FMOLHS is adopting Masimo Patient SafetyNet™, which provides supplemental remote monitoring and alarms at centralized view stations and two-way clinician notifications via Replica^®-equipped smartphones, to monitor 500 beds in their medical-surgical, orthopedic, bariatric, and cardiovascular step-down units. Combined, these monitoring advancements are designed to improve patient safety and care workflows by providing continuous, accurate bedside and surveillance monitoring and automating the transfer of patient data across FMOLHS’s continuum of care.  

“Implementing Masimo’s Radius PPG tetherless pulse oximetry has been a game-changer for our patients,” said Shantelle Graves, Senior Director of Respiratory Care and EEG at Our Lady of the Lake Regional Medical Center. “Additionally, with the integration of Masimo’s surveillance monitoring and automation technologies, clinicians’ workflows have become more streamlined and efficient. Accessing patient data and monitoring information has never been easier, allowing our nurses to spend more time at the bedside providing direct patient care. Masimo’s solutions are positively impacting our care team’s productivity, resulting in better patient outcomes and enhanced nursing satisfaction.”

Following a thorough evaluation to compare Masimo to their previous monitoring technology, FMOLHS, whose focus on enhancing patient safety was recently recognized by the Healthtrust Performance Group, concluded that Masimo SET^® and Patient SafetyNet offered clear advantages. Masimo SET^® has been shown in more than 100 studies to outperform other pulse oximetry technologies, significantly reducing false alarms and measuring more accurately and reliably during motion and low perfusion¹ – key to FMOLHS’s goal of more reliably monitoring pediatric and neonatal patients. Coupled with Masimo Patient SafetyNet for centralized remote monitoring, SET^® has been shown to reduce response team activations and ICU transfers by helping clinicians catch signs of patient deterioration sooner, improving patient safety and nursing workflows^2-5 – making the technology a crucial component of FMOLHS’s “virtual nursing” program.

Also important for FMOLHS was the Masimo Hospital Automation™ platform’s ability to automate ADT (admission-discharge-transfer) processes and the transfer of patient monitoring data to hospital electronic medical records (EMRs) for use throughout the healthcare system – improving care workflows and ensuring that doctors and nurses always have the most up-to-date and comprehensive data available to make more informed care decisions.

Joe Kiani, Founder and CEO of Masimo, said, “FMOLHS’ commitment to patient safety and care is exceptional; we are delighted to work with them to help them improve patient care.”

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁶ improve CCHD screening in newborns,⁷ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^2-5 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
3. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
4. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
5. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
6. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
7. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

About Franciscan Missionaries of Our Lady Health System  

Franciscan Missionaries of Our Lady Health System is one of the largest healthcare systems based in Louisiana and is the leading healthcare provider for more than half the state’s population. The health system is a non-profit, Catholic organization sponsored by the Franciscan Missionaries of Our Lady. Headquartered in Baton Rouge, Louisiana, the ministry serves patients in Louisiana and Mississippi through a network of hospitals, clinics, physicians and integrated health systems. The health system’s unified physician organization is comprised of more than 1,100 adult and pediatric primary care physicians and specialists. The system’s nine main campus hospitals include St. Francis Medical Center in Monroe, Our Lady of the Lake Regional Medical Center in Baton Rouge and Gonzales, Our Lady of the Lake Children’s Hospital in Baton Rouge, Our Lady of Lourdes Regional Medical Center, Heart Hospital, and Women's & Children's Hospital in Lafayette, Our Lady of the Angels in Bogalusa, and St. Dominic Hospital in Jackson, Mississippi. For more information, visit fmolhs.org.  

Forward-Looking Statements - Masimo

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SET^®, Radius PPG^®, Patient SafetyNet™, Hospital Automation™, and Replica^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including includingMasimo SET^®, Radius PPG, Patient SafetyNet, Hospital Automation, and Replica, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages;risks that FMOL fails to realize the expected benefits of Masimo technologies; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Announces Full Market Release of Stork^™ Smart Home Baby Monitor 

Masimo (NASDAQ: MASI) a global leader in noninvasive monitoring technologies, today announced the full U.S. market release of the Stork smart home baby monitoring system. Stork Vitals+, Vitals, and Camera combinations are now available for purchase online at www.MasimoStork.com and on shelves at major retailers including Best Buy and specialty retailers including Babylist.

“We are delighted to bring Masimo Stork to parents and caregivers in the United States,” said Joe Kiani, Founder and CEO of Masimo. “With the launch of Stork, parents for the first time can have access to a technology originally developed for the most challenging patients in hospitals, with a user interface that is a simple and easy-to-use app on a phone.” 

The Stork smart home baby monitor represents a significant advancement in smart baby monitoring technology, providing parents and caregivers a continuous and accurate view of their baby’s health data. Leveraging Masimo’s revolutionary noninvasive hospital neonate monitoring technologies, Stork offers a range of innovative features, including: 

• Continuous tracking of health data: Stork’s noninvasive sensing technology has been used by hospitals for more than 25 years and today monitors over 10 million babies around the world each year.¹ Stork tracks health data such as pulse rate, oxygen saturation (Sp0₂), and temperature, helping give parents greater awareness of their baby.
• 2K quad high-definition (QHD) capable video: With crystal-clear video and audio streaming capabilities, parents can keep a close eye on their baby from anywhere, at any time, through the companion smartphone app.
• Parent-tested mobile app: The Stork app’s user-friendly interface allows parents to customize room condition alerts, view historical data, and receive notifications about the sensor’s status.
• Secure and encrypted connectivity: With its hospital roots, Masimo prioritizes the security and privacy of its users. The Stork baby monitor features AES-256 bit encryption to safeguard sensitive data.

The Masimo Stork baby monitor system is comprised of several components and is available in multiple configurations. Masimo Stork Vitals+, the flagship solution, consists of a boot with sensor, video camera, and mobile app. The boot is made from an ultra-soft, comfortable medical-grade silicone that conforms gently to the baby’s foot and comes in three sizes to ensure a good fit and to accommodate babies up to 18 months old. The sensors embedded in the Stork boot are the product of meticulous engineering, harnessing Masimo’s decades of expertise in newborn monitoring to accurately and dependably detect babies’ pulse rate, Sp0₂, and temperature.

Stork’s high-resolution camera provides outstanding nighttime vision and offers high-quality two-way audio through the camera, letting parents hear and talk to their babies as if they were right next to them. The camera is also equipped with room condition monitoring to accurately report room temperature and humidity. All components are connected to the Masimo Stork app, which allows parents to see their baby’s monitoring data, view summaries of averages and trends, and share photos with others. Stork has been designed to open up many more incredible features, to be made available in the future, some for free and some for additional cost.

For consumers who do not require streaming video or want to extend baby tracking outside the home, the Stork Vitals solution replaces the camera with a health hub which connects the Stork boot and sensor to the Stork App, while still allowing parents to hear their baby and monitor room conditions.

Masimo Stork is an ideal gift for new and expecting parents, for baby showers, or as a thoughtful gesture for those who want to track health data to get to know their baby better. The Masimo Stork system ranges from $249 to $549 USD.

Masimo Stork is not sold as a medical device and should not be used for medical purposes.

For more information, visit www.MasimoStork.com.

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Estimate: Masimo data on file.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and Sp0₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338. 
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Stork^™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique technologies, including including Masimo Stork, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Evaluates the Use of Masimo PVi^® As an Indicator of Fluid Responsiveness to Guide Goal-Directed Fluid Therapy in Elderly Patients Undergoing Gastrointestinal Surgery 

Researchers Found That Fluid Therapy Guided by Noninvasive, Continuous PVi Reduced Cardiopulmonary Complications and Fluid Administered

Masimo (NASDAQ: MASI) today announced the findings of a prospective, randomized study published in Perioperative Medicine in which Dr. Yu Wang and colleagues at institutions in Shenzhen, Shaoguan, and Guangzhou, China evaluated the use of noninvasive, continuous Masimo PVi^®, as part of goal-directed fluid therapy (GDFT), to guide intraoperative fluid administration during gastrointestinal (GI) surgery on elderly patients by comparing it to conventional fluid therapy. The researchers found that patients in the PVi group had a significantly lower rate of cardiopulmonary complications (8.4% vs 19.2%) and had a significantly lower total volume of fluid administered (median 2075 ml vs. 2500 ml).¹

Noting the particular value of optimizing fluid management during GI procedures, especially in elderly patients, because of the high rate of postoperative complications and frequent fluid deficits (because of preoperative fasting, bowel preparation, and intraoperative fluid loss), the researchers sought to determine whether GDFT using Masimo PVi might improve outcomes in this challenging scenario. PVi, or pleth variability index, is a measure of the variations in perfusion index over the respiratory cycle, and has the advantage, compared to arterial line-based methods of gauging fluid responsiveness (e.g. stroke volume variation [SVV] and pulse pressure variation [PPV]), of being obtained via noninvasive Masimo rainbow SET^® pulse oximetry and Pulse CO-Oximetry. PVi is indicated as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. As the researchers note, PVi has been shown to perform similarly to invasive methods of fluid assessment, such as PPV and SVV, in a variety of surgeries.²

The researchers enrolled patients aged ≥ 65 years scheduled for elective GI surgery at two university hospitals between November 2017 and December 2020. Patients were randomly assigned to the GDFT group (n = 107) or the conventional fluid therapy (CFT) group (n = 104). In the GDFT group, fluid therapy was guided by PVi obtained from the photoplethysmographic waveform measured by fingertip rainbow^® Pulse CO-Oximetry sensors. The outcomes evaluated and compared between the two groups were: composite complications at 30 days after surgery; cardiopulmonary complications at 30 days (pneumonia, atelectatis, pulmonary edema, arrhythmia, and acute myocardial infarction); time to first flatus; postoperative nausea and vomiting; infections including anastomotic leak rates; and postoperative length of hospital stay.

The researchers found that the rate of cardiopulmonary complications, as well as the total volume of fluid administered intraoperatively, were statistically significantly lower in the GDFT (PVi) group, as highlighted in the table below. Although there was a trend toward shorter length of stay and lower anastomotic leakage rates in the PVi group, these and other outcomes were not statistically significantly different.

 

Outcome	GDFT (PVi) Group	CFT Group	p-Value*
Median volume of fluids administered (ml)	2075 (interquartile range: 1900, 2600)	2500 (2000, 3100)	0.008
Number (and percentage) of patients with one or more complications	46 (43%)	43 (41.3)	0.089
...with cardiopulmonary complications	9 (8.4%)	20 (19.2)	0.022
...with postop. nausea/vomiting	42 (39.3%)	35 (33.7)	0.398
Median time to first flatus (hours)	60 (interquartile range: 30, 93)	52 (34, 81)	0.475
Number (and percentage) of patients complicated by anastomotic leakage	1 (0.9%)	5 (4.8%)	0.201
Median postop. length of stay (days)	9 (interquartile range: 8, 14)	10 (8, 12)	0.614

 

 

The researchers concluded, “Among elderly patients undergoing GI surgery, intraoperative GDFT based on the simple and noninvasive PVi did not reduce the occurrence of composite postoperative complications but was associated with a lower cardiopulmonary complication rate than usual fluid management.”

Joe Kiani, Founder and CEO of Masimo, said, “We introduced PVi in 2007. It was the first and is still the only way of measuring fluid responsiveness noninvasively via pulse oximetry, with our pulse oximeters, at a fraction of the cost of invasive methods and without risk of invasive procedures to the patient. Since then, PVi has made a tremendous contribution to patient care, and its utility as a fluid responsiveness indicator has been shown in more than 100 independent, published studies.2 This latest study adds to the outcomes evidence that PVi can be used to help clinicians manage the fluid levels of their patients without invasive catheters.”

In the U.S., PVi is FDA 510(k) cleared as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Wang Y, Zhang Y, Zheng J, Dong X, Wu C, Guo Z, Wu, X. Intraoperative pleth variability index-based fluid management therapy and gastrointestinal surgical outcomes in elderly patients: a randomized controlled trial. Periop. Med. 2023. 12:16. DOI: 10.1186/s13741-023-00308-0. 
2. Published clinical studies on PVi can be found on our website at http://www.masimo.com. 
3. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. 
4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 
5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338. 
6. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. 
8.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 
9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
10. Estimate: Masimo data on file.
11. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo PVi^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique technologies, including including Masimo PVi, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Finds That Masimo SedLine^® Patient State Index (PSi) Has the Potential to Improve Brain Monitoring for Patients Sedated with Dexmedetomidine

Masimo PSi, a Processed EEG Parameter, “Better Captured” Changes in Brain State Compared to Other Assessment Methods

Masimo (NASDAQ: MASI) today announced the findings of a study published in Frontiers in Neuroscience in which Dr. Lichy Han and colleagues at Stanford University evaluated the ability of Masimo SedLine^® brain function monitoring to assess the sedation levels of patients undergoing drug-induced sleep endoscopy (DISE) with dexmedetomidine – a sedative with numerous advantages. The researchers found that Masimo Patient State Index (PSi), a SedLine parameter derived from electroencephalographic (EEG) data, was statistically significantly associated with dexmedetomidine dosage, and, along with another EEG metric, “better captured changes in brain state from dexmedetomidine and ha[s] potential to improve the monitoring of dexmedetomidine sedation.”¹

The researchers noted that while anesthesia induced with dexmedetomidine may more closely resemble natural sleep compared to other sedatives, which makes it particularly appropriate in procedures like DISE, its effects on the brain are inconsistent, which has limited its usage. Better sedation assessment – an improved understanding of its impact and corresponding EEG changes – could help support more widespread adoption of the drug. The researchers accordingly sought to compare and evaluate several methods of assessing sedation in such a scenario. Regarding the choice of EEG markers, they noted that “Previous EEG markers, such as the bispectral index, have been unable to determine differences elicited with dexmedetomidine (Kaskinoro et al., 2011), thus motivating the discovery of novel EEG markers associated with changes in brain state seen with dexmedetomidine sedation.”

They enrolled 51 patients undergoing DISE, for the diagnosis and possible treatment of obstructive sleep apnea, who were sedated with dexmedetomidine and continuously monitored using Masimo SedLine. The concentration of the drug in their bloodstream was determined using a pharmacokinetic model. The concentration levels over time were recorded alongside the values derived from four methods of assessment, two metrics and two analyses: 1) the Richmond Agitation-Sedation Scale (RASS), 2) the SedLine Patient State Index (PSi), 3) spectral edge frequency (SEF95), the frequency below which 95% of total EEG power was contained, and 4) the correlation dimension (CD), a type of fractal dimension used to assess the complexity of a system. To evaluate the efficacy of these methods, the researchers compared them both against dexmedetomidine concentration and against each other.

Comparing the assessment methods to dexmedetomidine concentration, the researchers observed that RASS scores decreased with increasing dexmedetomidine concentration but noted that, “Overall, the RASS score was least able to capture the brain state changes seen with dexmedetomidine, suggesting other metrics for titrating dexmedetomidine sedation may be of greater value.” They found that PSi, SEF95, and CD all decreased statistically significantly with increasing dexmedetomidine concentration (p < 0.001, p = 0.006, and p < 0.001, respectively), “a clear dose-dependent decrease with an inflection point.” 

Comparing the methods to each other, they found that PSi, SEF95, and CD all decreased statistically significantly with decreasing RASS score (p < 0.001, p < 0.001, and p = 0.02, respectively), most notably at deeper levels of sedation, suggesting that this is when they may be most beneficial. CD and SEF95 were statistically significantly correlated (p < 0.001, r = 0.515), but there was a subset of points that exhibited high SEF95 but low CD. PSi was most strongly correlated with SEF95 (p < 0.001, r = 0.631). 

The researchers concluded, “Complex EEG metrics such as PSi and CD, as compared to RASS score and SEF95, better captured changes in brain state from dexmedetomidine and have potential to improve the monitoring of dexmedetomidine sedation.” In their discussion, they noted that, “CD excelled at reflecting changes seen with rising dexmedetomidine concentration but appeared to exhibit a ceiling effect, whereas PSi had the most significant relationship with the RASS score. Both metrics were able to capture brain state changes corresponding to increased dexmedetomidine dose, showed decreased sensitivity to observer variability and artifact, and corresponded to currently used infusion dosages in pharmacokinetic simulations.”

Study lead authors Lichy Han, MD, PhD and David Drover, MD, Perioperative and Pain Medicine at Stanford University, commented, “This study provides one more step in the journey to understanding SedLine processed EEG parameters that can guide sedation levels. In this case, dexmedetomidine, a widely used sedative, which has not been fully characterized by processed EEG, was titrated using standard indices PSi, SEF95, as well as fractal dimension (CD) commonly applied to time series data like EEG. In contrast to BIS, SedLine parameters (particularly PSi) were able to characterize processed EEG changes that correlated with dexmedetomidine sedation level and concentration, and these parameters correlated better than the subjective measure RASS (the most widely used clinical measure of sedation depth). This work helps clinicians use SedLine as an objective measure reflecting how the brain is responding to this important sedative, dexmedetomidine.”

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Han L, Drover DR, Chen MC, Saxena AR, Eagleman SL, Nekhendzy V, Pritchard A and Capasso R. EEG response of dexmedetomidine during drug induced sleep endoscopy. Front. Neurosci. 2023. 17:1144141. doi: 10.3389/fnins.2023.1144141
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SedLine^® and PSi. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including including Masimo SedLine^® and PSi, contribute to positive clinical outcomes and patient safety;risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Hospital La Fe Expands Telehealth Program with Masimo W1™ for Preoperative Patients

Top Spanish Hospital Builds on the Success of Its Postoperative Telemonitoring Program with Masimo SafetyNet^®

Masimo (NASDAQ: MASI) today announced that Hospital La Fe in Valencia, Spain, is expanding its telehealth and telemonitoring program with the Masimo W1™ advanced health tracking watch. Masimo W1, which offers accurate, continuous measurements of key physiological parameters, is available outside the U.S. as a medical device that integrates with the Masimo SafetyNet^® remote patient management and telehealth platform. Hospital La Fe, one of the highest ranked hospitals in Spain and the world, has been using Masimo SafetyNet with Radius PPG^® tetherless monitoring as part of its enhanced recovery pathway program for post-surgical patients since last year. Based on the initial success of that program, a hospital team led by Surgical Director Dra. M. Argente, MD, PhD, now plans to equip patients scheduled for elective surgery with Masimo W1 watches in advance, with the goal of improving prehabilitation through analysis of the heart rate variability data gathered by the watch.

Joe Kiani, Founder and CEO of Masimo, said, “Hospital La Fe has long set the bar for successful use of telehealth and virtual care – long before the pandemic. We were gratified that they chose Masimo SafetyNet as the platform for their postsurgical home monitoring program, helping them send patients home sooner and keep track of patient status to head off postoperative complications more proactively. We are excited for them to build on that foundation with the addition of Masimo W1. Masimo W1 will allow Hospital La Fe clinicians to collect a rich set of insightful baseline data for their preoperative patients, allowing them to better understand what is normal and what is not for each patient, prior to their undergoing invasive treatment.”

Oscar Díaz Cambronero, MD, PhD, Head of Perioperative Medicine in the Department of Anesthesiology at Hospital La Fe, said, “Implementing Masimo SafetyNet remote monitoring solutions in an enhanced recovery pathway programme in Hospital la Fe in Spain is allowing pro-active diagnosis of postoperative complications – improving patient safety and early hospital discharge in selected surgical patients. This future project will test the impact of telemonitoring with Masimo W1 in the preoperative setting for upgrading prehabilitation and improving patient condition and engagement.”

Masimo W1 for use in medical applications is not FDA cleared in the U.S.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo W1™ and Masimo SafetyNet^®, as well as the adoption of Masimo W1 by Hospital La Fe. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including including Masimo W1 and Masimo SafetyNet, contribute to positive clinical outcomes and patient safety;risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that Hospital La Fe fails to realize the expected benefits of Masimo W1; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo and Clinton Foundation Host Roundtable Addressing Overdose and Addiction Crisis

Roundtable, which included a special fireside chat with Masimo Founder & Chairman Joe Kiani and President Bill Clinton, held at Clinton Foundation offices in New York City

Participants included national leaders in healthcare, education, and policy

Masimo (NASDAQ: MASI), and the Clinton Foundation today hosted an in-person roundtable addressing the overdose and addiction crisis. Joe Kiani, Founder and CEO of Masimo, and President Bill Clinton, 42nd President of the United States and Founder and Board Chair, Clinton Foundation, led the conversation at the Foundation offices in New York City. Participants included national opioid and addiction specialists, hospital and academic executives, community members, and local, state, and national elected officials.

The event brought together experts and peers to collaborate on evidence-based solutions designed to help patients affected by the overdose and addiction crisis. The discussion highlighted solutions such as Bridge^™ and Opioid Halo^™ from Masimo—the first winner of the FDA’s Opioid Innovation Challenge to have an authorized device addressing the crisis—designed to prevent overdose, save lives, and reduce the stigma surrounding opioid use. Attendees also had the opportunity to test both products onsite at an Opioid Safety Demo table. 

Joe Kiani, Founder, Chairman and CEO of Masimo, said, “At Masimo, we are committed to creating evidence-based solutions that fill in existing gaps in patients’ support network. We must collectively work together to eliminate the stigma around addiction and fight the opioid crisis, one of our nation’s most pressing public health challenges and the leading cause of accidental deaths in the U.S. My hope is that our conversation today will inspire a greater dialogue around how communities can better support opioid users in the hospital and at home, reducing deaths and stopping the cycle of addiction.”

President Bill Clinton said, “Overdose deaths reached an all-time high last year with more than 109,000 lives lost. If we’re going to have a chance at reversing the tide, it’s going to take all of us — more hospitals and clinics, more stakeholders and community leaders, and more innovators like Joe Kiani and Masimo. Their commitment to fighting the overdose crisis has led to breakthroughs that can prevent overdose deaths and help people on the road to recovery.” 

Among the key participants in the roundtable today were:

Chris Thrasher, Chief Executive Officer of Substance Use Disorders and Recovery, Clinton Foundation, who said: “A key component missing from the conversation is how can technology help solve this crisis. With these evidence-based technological solutions, we can and will save one life at a time.”

Dr. Seonaid Nolan, Head, Interdepartmental Division of Addiction, Providence Health Care and Clinician Scientist, BC Centre on Substance Abuse said: “Collective efforts are better than each individual effort. To turn the tide, it is important we come together, across disciplines, to develop a comprehensive approach to linking people to the services they need at the time they want it.” 

Chief Tom Synan, Chief of Police, Newtown Police Department, Ohio, said: “We must come together to find new ways to help serve those with substance use disorder. We need to fill in the gaps to provide better service to those in need and utilize evidence-based technologies like Bridge which can be used in various sectors of the community, such as the justice system and health care system.”

Aldo Carmona, M.D., Senior VP of Clinical Integration and Chairman of Anesthesia, St. Luke's University Health Network, said: “We know the opioid crisis significantly affects families. Understanding people’s genetic makeup matters and it could help us identify high-risk populations.”

Sean O’Donnell, MS, Executive Director, Foundation for Recovery, said: “We need more innovation in this space. We’ve got heart. We’ve got data. We’ve been studying this crisis and the solutions. Now, we need to ensure those who need these products most can access them. It is time for action.”

Ryan Hampton, Co-Founder and Executive Director, Mobilize Recovery, said: “People are inspired and ready to take action. There is a lot of innovation and intent to break silos between sectors. When we come together and share our learnings, we make giant strides towards addressing this crisis by making actionable commitments for impactful change.”

Karl Leonard, Sheriff, Chesterfield County Sheriff’s Office, Virginia, said: “Today’s event brought together leaders across disciplines to discuss how we can effectively and efficiently work together to build momentum.”

Jeffrey A. Thomas, MHS, LPC, CACDC, Chief Executive Officer, White Deer Run, said: “We need to further implement technology in the treatment of opioid dependence and move away from outdated techniques and practices. Opioid users who are chemically dependent desire a powerful, timely solution, and Bridge delivers just that; we were astounded by how well the device worked and now use it to reduce recidivism and reduce abandonment of treatment. We’re a great case study for abatement funds to support the community in need.”

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature. 

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique technologies contribute to positive user experience and user safety; risks related to our belief that Masimo technology breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws. 

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Expands Into the Personalized Hearables Market with Denon PerL™ True Wireless Earbuds, Featuring Masimo Adaptive Acoustic Technology™ (AAT™)

Masimo (NASDAQ: MASI), a leading developer of medical technology solutions and consumer health and audio devices, is expanding its premium Denon brand to introduce its latest innovation, Masimo AAT™ (Adaptive Acoustic Technology™). Denon PerL™ and PerL Pro™ True Wireless (TWS) Earbuds, featuring Masimo AAT, allow users to create a personal audio profile to optimize the sound quality of the headphones. The name of the earbuds was chosen to represent Masimo’s goal of transcending how people enjoy music: through a truly Personalized Listening experience. 

Joe Kiani, Founder and CEO of Masimo, stated, “The era of one-sound-fits-all is over. PerL automatically figures out the optimal sound for each individual, to cater to your unique ears. I am personally blown away by how good PerL Pro is. I have not heard my music like this since I was 18. PerL is intuitive, comfortable, and ergonomic. With the launch of PerL, we are transcending the listening experience.  We can’t wait to have our customers join us in this new paradigm.”

Hearing varies from person to person and can impact the listening experience. The two Denon PerL TWS models—Denon PerL Pro and Denon PerL—use proprietary Masimo technology to measure faint otoacoustic emissions (OAEs), which are produced by the inner ear in the presence of a range of tones played to assess each person’s unique response to sound. Once the OAEs are analyzed to determine how sensitive a person’s ears are to each frequency, a personal hearing profile is created in the Denon PerL Headphone app, using artificial intelligence. This individualized profile provides unparalleled depth, detail, and clarity – tuned perfectly to your own hearing and elevated by Denon’s vivid and spacious signature sound. 

Another key benefit, unique to Denon PerL Pro earbuds, is the delivery of high-quality sound wirelessly. While standard Bluetooth^® technology compresses and decompresses audio during wireless transmission, Denon PerL Pro earbuds provide a streaming experience similar to listening to a CD. This means users can enjoy high-fidelity streaming sources with excellent audio fidelity. PerL Pro also creates a surround sound effect that enhances the overall audio experience in a compact and comfortable wireless earbud design. 

Both the Denon PerL Pro and PerL models offer active noise cancellation and a more transparent social mode, allowing you to tune the world out or let it in. PerL Pro features eight microphones (vs. four in PerL) and upgraded noise cancellation, automatically adjusting the level of cancellation according to the amount of leak-through, the environment’s sound, and the tightness of fit in the ears. 

Denon PerL users will be able to elevate their personalization journey by viewing their unique profiles through the Denon Headphones app for iOS and Android, with the ability to customize features such as selective noise canceling or Social Mode and on-earbud touch controls such as play/pause, skip track, change volume, and more.

A limited number of Denon PerL and PerL Pro headphones are now available for purchase at Denon.com for $199 and $349, respectively, with a fuller rollout later this year.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofDenon PerL™, Denon PerL Pro™, and Masimo AAT™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results;risks related to our belief that Masimo's unique technologies, including Denon PerL, Denon PerL Pro, and Masimo AAT, contribute to positive user experience and user safety; risks that a fuller rollout of Denon PerL and Denon PerL Pro headphones fails to occur later this year; risks related to our belief that Masimo technology breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Community Health System Expands Use of Multiple Masimo Technologies, System-wide

Premier Central Valley Provider Adopts Masimo SET^®, Root^®, Rad-97^®, and Much More Across Multiple Hospitals

Masimo (NASDAQ: MASI) and Community Health System (CHS), based in Fresno, California, today announced that CHS is adopting a variety of advanced Masimo monitoring technologies and solutions across its campuses. CHS, a large four-hospital network, provides all levels of care across the Central Valley area of California, and is standardizing on Masimo SET^® pulse oximetry and deploying 800 Root^® Vital Signs Monitoring and Connectivity Hubs and 200 Rad-97^® Pulse CO-Oximeters^® with NomoLine^® capnography, system-wide. 

In the next phase of its medical technology expansion, CHS will focus on its patient surveillance monitoring initiative, with plans to implement Masimo Patient SafetyNet^™ for centralized remote patient monitoring, taking advantage of Masimo Hospital Automation^™ to seamlessly transfer patient data into electronic medical records (EMRs) to streamline nursing workflows and improve patient safety. An additional area of focus is expanding its perioperative monitoring capabilities, with planned installation of advanced Masimo rainbow^® parameters such as SpHb^® noninvasive and continuous hemoglobin monitoring and PVi^® pleth variability index, alongside SedLine^® brain function monitoring, O3^® regional oximetry, and LiDCO^® hemodynamic monitoring. 

Joe Kiani, Founder and CEO of Masimo, said, “We are honored to work with partners like CHS to improve patient outcomes across the continuum of care. Their dedication to ensuring their clinicians have access to the tools they need to provide their patients with the highest possible quality care – the most advanced noninvasive monitoring technologies, the most versatile patient monitors, the most sophisticated automation and connectivity solutions – is inspiring.”

CHS Chief Nursing Officer and Senior Vice President Daniel Davis, R.N., said, “This expanded partnership allows us to integrate Masimo’s best-in-class, noninvasive monitoring technology across all the hospitals in our health system. We expect it to optimize workflows and provide additional insights into patient status that will ultimately help us improve patient outcomes.”

Cheri Provancha, DBA, DML, Vice President of Supply Chain, Security, and Clinical Engineering at CHS, added, “We are excited to expand our relationship with Masimo and provide our outstanding clinicians with the advanced noninvasive technologies, monitoring devices, and automation solutions they rely on to provide the best care possible for residents of the Central Valley.”

CHS is a private, not-for-profit healthcare network based in Fresno, California. The system operates four hospitals and a cancer institute along with several long-term care, outpatient, and other healthcare facilities. In 2014, CHS implemented Masimo SET^® for Women and Children’s Services and Neonatal Intensive Care at the Community Regional Medical Center campus, and have since expanded to standardize across all care areas at their campuses.

Their positive experience using Masimo technology – for clinicians and patients alike – was the driving force behind this multi-wave expansion and standardization on Masimo technologies.

 

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature. 

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo W1^™ and Masimo SafetyNet^®, as well as the adoption of Masimo W1 by CHUV. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo W1 and Masimo SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages;risks that CHUV fails to realize the expected benefits of Masimo W1 or that CHUV fails to provide Masimo W1 to patients later this year in the manner described in this press release; ; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Lausanne University Hospital (CHUV) Anesthesiology Department Adopts Masimo W1™ for Use in Preoperative Patient Assessment 

Masimo (NASDAQ: MASI) today announced that the Department of Anesthesiology at the Lausanne University Hospital (CHUV), one of Switzerland’s premier academic institutions, has chosen to make the Masimo W1™ advanced health tracking watch a key part of its pre-surgical patient assessment research program. This initiative, led by Professor Patrick Schoettker, Head of Anesthesiology at CHUV and a renowned expert in airway management, wireless monitoring, and the digital transformation of healthcare, is designed to help better inform anesthesiologists and surgical teams about their patients’ physiological status prior to surgery, with the ultimate goal of improving patient outcomes. Masimo W1, which offers accurate, continuous measurements of key physiological parameters, is available in Europe as a medical device that integrates with the Masimo SafetyNet^® remote patient management platform.

Joe Kiani, Founder and CEO of Masimo, said, “We are excited to deepen our relationship with anesthesiologists at the CHUV and to help them leverage Masimo W1’s health tracking capabilities to help perioperative teams establish more insightful baseline physiological data about their patients.  The baseline data can then allow clinicians to know what is normal and abnormal for each patient they care for in the hospital.  Also, with Masimo W1, they can remotely monitor the patient post surgery at home when appropriate and reduce how long the patient remains in the hospital. We appreciate Dr. Schoettker and his team for recognizing the role that our technology can play in helping his department and the CHUV provide even better care for patients undergoing surgery, and we look forward to seeing Masimo W1 make a true difference in the lives of their patients.”

CHUV’s preoperative patient assessment program was launched in 2022, with the goal of using innovative technologies to identify areas of health and behavior improvements for each individual patient. Using multimodal prehabilitation, the team aims to address the physical, nutritional, and psychological needs of colorectal surgical patients. Aggregating data related to patients’ demographics, vital signs and behavior optimization will allow the team to offer more personalized management before, during, and after anesthesia and surgery. Starting later this year, as part of this program, patients scheduled for elective surgery will be provided with Masimo W1 watches two weeks in advance to help establish their baseline vital signs data, which will be relayed to clinicians during the preoperative anesthesia visit at the CHUV. Using the Masimo SafetyNet dashboard, perioperative teams will be able to use this data to develop a more nuanced and complete physiological profile of patients prior to surgery, allowing them to make more informed care decisions.

Prof. Schoettker commented, “We are looking forward to aggregating as much patient data as possible to better understand how each individual can benefit from a tailored approach. The time of ‘one size fits all’ anesthesia is over and personalized patient management is on the rise. While our mentors have helped make the operating room the safest place for the patient, with the highest density of highly qualified specialists per patient, our mission is now to offer that same level of quality and safety before and after any surgical procedure.”

Masimo W1 for use in medical applications is pending FDA clearance in the U.S.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo W1™ and Masimo SafetyNet^®, as well as the adoption of Masimo W1 by CHUV. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo W1 and Masimo SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages;risks that CHUV fails to realize the expected benefits of Masimo W1 or that CHUV fails to provide Masimo W1 to patients later this year in the manner described in this press release; ; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Announces FDA 510(k) Clearance of Radius VSM™ 

Transformational, Versatile, Patient-worn, Continuous Vital Signs Monitor Features Wide Range of Physiological Measurements on a Compact, Scalable Platform 

Masimo (NASDAQ: MASI) today announced that Radius VSM™, a patient-worn, continuous multi-parameter vital signs monitor, has received FDA 510(k) clearance. Designed on a modular platform, Radius VSM allows clinicians to monitor a wide variety of physiological measurements, including Masimo SET^® pulse oximetry, noninvasive blood pressure, temperature, respiration rate, and electrocardiography (ECG). By combining the reliability and accuracy of larger bedside monitors with the comfort and freedom of a wearable device, Radius VSM allows ambulation and movement while ensuring patients remain continuously monitored. With its flexibility and expandability, Radius VSM can be easily scaled to match each patient’s unique monitoring needs and level of acuity, across the continuum of care, and to accommodate surges in patient volume.

Joe Kiani, Founder and CEO of Masimo, said, “Radius VSM’s unique scalability, versatility, advanced connectivity, and broad range of accurate and automated continuous measurements – all in a wearable device that can be quickly and easily deployed anywhere in the hospital – make it a game-changing tool for clinicians everywhere. Doctors, nurses, and patients in Europe are already experiencing the advantages of Radius VSM and we are excited to share them with U.S. hospitals now too.”

As a modular, wearable device, Radius VSM allows providers to equip any hospital bed with comprehensive monitoring, with the ability to quickly add or remove measurement technologies to match each monitoring scenario and offer more personalized care – without additional bedside equipment, network infrastructure, or any tethered connections. Radius VSM can operate as a self-contained device, with high-quality waveform and parameter trend data shown on its built-in multi-touch LED display, with visual and audible alarms and a built-in rechargeable battery. Or, Radius VSM can connect wirelessly to Masimo bedside monitors like Root^® and to the Masimo Hospital Automation™ platform, simplifying clinical workflows by automating patient data transfer to remote monitoring systems like Masimo Patient SafetyNet™ and electronic medical records (EMRs) – enabling its use as a part of a patient surveillance system and ensuring up-to-date physiological data is available to clinicians throughout the hospital. For example, integrating data from Radius VSM into Patient SafetyNet extends its reach across the hospital for clinicians remotely monitoring patients at centralized viewing stations, viewing continuous monitoring data on their Replica^®-equipped smartphones, and benefiting from the workflow automation of the Halo ION^® patient scoring system – all regardless of where patients are in the hospital, even if they are on the move.

Using a multi-functional pod and a variety of modules and noninvasive sensors designed to prioritize comfort and ergonomics, Radius VSM offers the following measurement technologies:

• Clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, including oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), pleth variability index (PVi^®), and plethysmographic respiration rate (RRp^®).
• Multiple respiration rate measurements, including measurement from the pleth, from the sound of breathing, and from impedance.
• Measure-on-inflation noninvasive blood pressure (NIBP), featuring single-patient-use cuffs and automatic intervals (which reduces the need for periodic manual clinician measurement).
• Continuous skin temperature measurements with notifications when clinician-specified temperature thresholds are breached.
• Patient orientation, position, and activity monitoring, alerting clinicians to unsupervised patient movement and possible patient falls, as well as preventable pressure injuries.
• ECG: continuous 6-lead monitoring (I, II, III, aVR, aVL, and aVF) with heart rate, respiration rate, and lethal arrhythmia detection, using single patient use easy-to-apply pre-connected 3-electrode leadwire.
• rainbow Acoustic Monitoring^®, which uses an adhesive sensor to detect the acoustic signals produced by airflow in the upper airway and convert these patterns into respiration rate, also visualized as a waveform. 

Peter Pronovost, MD, PhD, FCCM, Chief Quality and Clinical Transformation Officer at University Hospitals, Ohio, and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, said, “Radius VSM represents another radical transformation of care by Masimo, allowing clinicians to monitor based on patient acuity, not their location. With this new technology, not only can every bed have pulse oximetry monitoring, but if patient acuity increases, we can also easily scale up monitoring, even including ECG, without having to add new hardware or hardwire anything. With the staff shortages in hospitals and the high volume of patients, clinicians need the flexibility to put patients in any bed and ensure that that bed has the capability to monitor each patient appropriately. With Radius VSM, we will have enormous flexibility to manage patient risk across a hospital or, in our case, an entire health system: we can tailor what gets monitored to meet each patient's need, for truly personalized monitoring.  And from a safety perspective, by allowing us to monitor patients based on their individual acuity and needs, linked to clinical protocols, we can significantly drive down the risk of possible harm in the hospital.”

Joan Carles Rueda, Deputy Director of Medical Technology at FGS Hospital de la Santa Creu i Sant Pau, Barcelona, Spain, where Radius VSM is already in use, said, “Radius VSM is a reliable solution that combines the advantages of a comprehensive monitoring platform with the autonomy of telemetry, giving the patient the safety and freedom to make their hospital stay more humanized. From a technical perspective, we had no doubt about the reliability of the solution as we have been working with Masimo for many years now. They provided the resources to ensure the proper operation of the technology, even evaluating our wireless network, and it has been working smoothly since the installation. We see the device design as an easy to maintain technology as it all is modular and plug and play.”

Thomas Callahan, MD, Principal Investigator and Director of the Inpatient Hospital Service for Cardiac Electrophysiology and Pacing, Cleveland Clinic, commented, “We are excited to have gained early experience with this next generation inpatient monitoring system at our center as part of the investigational study. What helps differentiate this technology from existing systems is high fidelity continuous ECG monitoring in a compact modular configuration and integration with high precision optical, electrical, and acoustic sensors for blood pressure, respiratory rate, pulse oximetry, and motion.”

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Radius VSM™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Radius VSM, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages;risks that Masimo fails to realize the expected benefits of FDA 510(k) clearance for Masimo Radius VSM; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Announces Major Expansion of the HEOS^® Platform

Secure Masimo Health Data Tracking Now Enabled on 4 Million Devices from Denon, Marantz, and Definitive Technology

Masimo (NASDAQ: MASI) today announced the global expansion of the HEOS platform, enabling an always-on connection to the Masimo Health secure cloud for four million devices and empowering consumers with an enhanced health tracking experience. This software upgrade allows Masimo’s cutting-edge devices and secure cloud solution to seamlessly integrate with HEOS-enabled sound bars, wireless speakers, amplifiers, and receivers from Denon, Marantz, and Definitive Technology worldwide – including the U.S., Canada, United Kingdom, Japan, and Australia, with more countries going live later this year.

“We are excited to expand the footprint and capabilities of our HEOS platform with our wearables and provide our customers with health tracking truly integrated with their favorite audio solutions,” said Joe Kiani, Founder and CEO of Masimo. “Now, four million devices around the world can help improve the lives of our customers by combining the joy of high-quality audio with the convenience of continuous and accurate health and wellness tracking from the comfort of their own homes.”

Masimo’s groundbreaking HEOS ecosystem platform, combined with Masimo's latest wearable health and wellness devices – such as the Masimo W1^™ advanced health tracking watch, and soon the Stork^™ baby monitor and Radius Tº^® continuous thermometer, select Masimo medical devices, and more – will allow users to keep track of their health and wellness, as well as share their data with loved ones and clinicians, paving the way for the next chapter in telehealth innovation and cohesive care.

This latest ecosystem innovation not only wirelessly relays health data to the HEOS-enabled home device and Masimo’s secure Health cloud for storage, analysis, reporting, and transfer, but now offers a revolutionary way to connect and interact with health technologies from the company that, among many other medical breakthroughs, invented Masimo SET^® – the primary pulse oximetry at 9 of the top 10 U.S. hospitals.¹

“The HEOS platform embodies the true essence of luxury in the modern era, where health and wellness take center stage. These new capabilities redefine what it means to live a life centered around wellness, and empower individuals to embrace self-care as an essential part of that life, transforming their lives with innovative technology and personalized insights,” Mr. Kiani continued. “We believe the health hub feature will not only differentiate Masimo audio products in the eyes of consumers worldwide, but also bring forth the next level of health and wellness by allowing connected care as consumers move around tetherless and even smartphone-less.”

Whether it’s enjoying music in the living room, kitchen, or bedroom, experiencing movie night with the family, or getting a workout in their home gyms, users all over the globe can effortlessly connect and track and record key health data from Masimo wearable monitoring devices, including pulse rate, oxygen saturation, respiration rate, hydration index, and more, using their HEOS-enabled devices. Customers will be able to access this new functionality through a cloud software update to their existing devices, which ensures a hassle-free transition to the enhanced music and health hub platform.

Some technologies and devices described may not be available or approved in every market.

 

 

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles. 
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92. 
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338. 
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012. 
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302. 
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Orange County Business Journal Names Masimo’s Micah Young CFO of the Year 

Micah Young, Chief Financial Officer of Masimo (NASDAQ: MASI), has been awarded CFO of the Year by the Orange County Business Journal (OCBJ). In presenting the award, Outstanding CFO of a Public Company, at last night’s ceremony in Irvine, OCBJ Publisher Richard

Reisman commended Mr. Young for delivering strong shareholder returns, significantly increasing Masimo’s annual investor outreach, and playing a critical role in the execution of six acquisitions and one licensing deal – all since joining Masimo in 2017.

Joe Kiani, Founder and CEO of Masimo, said, “I’m thrilled for Micah to receive such well-deserved accolades from OCBJ. In his six years with Masimo, he has quickly proved himself to be an invaluable asset to our company and one of my most trusted advisors. He’s helped propel us to new heights, delivering impressively for our shareholders and helping steer Masimo’s finances through a period of rapid growth and exciting expansion into new markets. Congratulations, Micah, and thank you to OCBJ for this recognition of his excellence.”

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Cambridge University Hospitals Expands Virtual Care Program with Masimo W1™ 

Neuchatel, Switzerland - May 8, 2023 - Masimo (NASDAQ: MASI) today announced that Cambridge University Hospitals NHS Foundation Trust, U.K. is adopting the Masimo W1™ advanced health tracking watch for use in its telehealth and telemedicine programs. Masimo W1, which offers accurate, continuous measurements of key physiological parameters, is available in the UK as a medical device that integrates with the Masimo SafetyNet^® remote patient management platform.

Joe Kiani, Founder and CEO of Masimo, said, “Masimo W1 represents not only the future of personal health but is playing a vital role in the expansion of remote healthcare. Built on our decades of expertise developing breakthrough noninvasive medical monitoring technologies, Masimo W1 is designed to aid valued hospital partners like Cambridge in accelerating their virtual hospital and telehealth programs – ultimately helping to improve patient outcomes while reducing the cost of care. We are excited for Cambridge clinicians and patients.” 

Cambridge University Hospitals NHS Foundation Trust launched its virtual ward program in 2022, as part of a National Health Service (NHS) England telehealth initiative designed to promote earlier patient discharge to the home. More than 20 specialties across the hospital now participate in Cambridge’s virtual program, which sends patients home with a variety of Masimo products – such as MightySat^® and wearable medical devices like Radius PPG^®, Radius Tº^®, and now Masimo W1 – that allow monitoring and vitals signs data to be relayed to clinicians back at the hospital. Via the Masimo SafetyNet clinician dashboard, hospital clinicians can keep an eye on their patients’ physiological status from afar, allowing patients to stay monitored in the comfort of their own homes. 

Dr. Iain Goodhart, Clinical Director of the Virtual Hospital Program at Cambridge University Hospitals NHS Foundation Trust, commented, “Masimo W1 will help us expand our Virtual Hospital program by offering continuous monitoring of oxygen saturation and pulse rate, as well as ECG spot-checking, in a comfortable, easy to use watch. We hope that, integrated with Masimo SafetyNet, the telehealth platform we already use, Masimo W1 can help support more confident patient discharge and management for patients who, before our Virtual Hospital program, might have needed to stay longer in the hospital. We’re excited to incorporate Masimo W1 into our telehealth practices.” 

Masimo W1 for use in medical applications is pending FDA clearance in the U.S.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo W1™ and Masimo SafetyNet^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo W1 and Masimo SafetyNet, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that Cambridge University Hospitals fails to realize the expected benefits of Masimo W1; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Stork™ Delivers State-of-the-Art Baby Monitoring to the Home 

Irvine, California - May 1, 2023 - Masimo (NASDAQ: MASI) a global leader in pulse oximetry and other innovative noninvasive monitoring technologies, today announced the launch of Stork, a revolutionary home baby monitoring system. This innovative system offers parents insights into their baby’s health data, helping them learn more about and be better connected with their baby.

“When we set out in 1989 to reinvent pulse oximetry, we named the project ‘Stork’ because our hope was that this technology would help reliably bring healthy babies home to their parents,” said Joe Kiani, Founder and CEO of Masimo. “With Stork’s introduction today, we’ve taken our passion for newborn care and our innovative and groundbreaking technologies to craft a solution that we hope will give parents greater insights into their babies and help them live healthier lives. Parenting is the hardest thing one loves to do. With Stork, our goal is to improve the parenting experience through a seamless, thoughtful integration of advanced and trusted health technologies that bring real data to parents.” 

“We designed Stork so parents and their babies can stay connected, when they can’t be next to each other,” continued Mr. Kiani. “Today’s parents are technologically sophisticated and better educated about their babies than ever. They track their own health data and know how managing that data can help them understand more about themselves. With Stork, we bring them the highest quality data so that they can be vigilant and learn even more about their babies.” 

The Masimo Stork monitoring ecosystem, which comprises several components, will be available in multiple configurations. Masimo Stork Vitals+, the flagship solution, consists of a boot with sensor, video camera, and a mobile app.

The Masimo Stork boot is made from an ultra-soft, comfortable medical-grade silicone that conforms gently on the baby's skin and comes in three sizes to ensure a good fit. The boots are designed to grow with the baby (up to 18 months old). The sensors embedded in the Stork boot are the product of meticulous engineering to harness decades of expertise in newborn health to detect babies’ oxygen saturation (SpO₂), pulse rate, and temperature with remarkable accuracy and dependability.

Masimo Stork also features a 2K QHD-capable, high-resolution camera with a mobile app. The Stork camera provides outstanding nighttime vision and offers high-quality two-way audio through the camera, letting parents hear and talk to their babies as if they were right next to them. The camera is also equipped with room condition monitoring to accurately report room temperature, humidity, and noise levels. All components are connected to the Masimo Stork app, which allows parents to see their baby’s monitoring data and milestones; view summaries of averages and trends; and coming soon, share images directly with others. The simple and intuitive app contains built-in educational tools to empower parents with the confidence to know what’s important, when it’s important.

For consumers who do not require streaming video, the Stork Vitals solution replaces the camera with a health hub which connects the Stork boot and sensor to the Stork App, while providing two-way audio and the ability to monitor room conditions.

Masimo Stork is an ideal gift for new and expecting parents, for baby showers, or as a thoughtful gesture for those who want to track health indicators to get to know their baby better. The Masimo Stork system bundles range from $249 to $549 USD. Bundles are now available for pre-order in the U.S. at MasimoStork.com and will begin shipping in June 2023.

Masimo Stork is not for medical purposes.

The Masimo Story

34 years ago, two engineers undertook the daunting task of reimagining pulse oximetry in order to address an issue previously thought “unsolvable”: how to make pulse oximetry monitoring accurate and reliable on the most vulnerable patients of all, premature babies in the NICU. Their groundbreaking innovation, known as Masimo Signal Extraction Technology^®, or SET^®, has transformed patient care, reducing mortality and morbidity, and giving clinicians more time to focus on their patients and not their previously unreliable pulse oximeters.¹ Today, Masimo SET^® is used to continuously monitor more than 200 million patients a year around the world,² and is the primary pulse oximetry at 9 of the top 10 U.S. hospitals.³

Over the years, Masimo’s unwavering dedication to enhancing outcomes for the most delicate and youngest patients has resulted in significant reductions in neonatal blindness from retinopathy of prematurity,⁴ and significant improvements in screening newborns for critical congenital heart disease.⁵ Its original breakthrough innovation, SET^®, has been shown to outperform other pulse oximetry technologies in more than 100 independent and objective studies.¹ With Stork, which uses that same technology, Masimo now offers that same level of superior performance and reliability in a baby monitor.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,² and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.³ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Estimate: Masimo data on file.
3. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview
4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
6. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo Stork™ and SET^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo Stork and SET^®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Announces FDA Clearance of the Rad-G^® with Temperature 

Irvine, California - April 18, 2023 - Masimo (NASDAQ: MASI) today announced that the Rad-G^® with Temperature has received FDA 510(k) clearance. Rad-G with Temperature is a rugged, versatile, handheld monitor that provides clinically proven SET^® pulse oximetry, respiration rate from the pleth (RRp^®), and other important parameters alongside non-contact infrared clinical thermometry. With its long-lasting rechargeable battery, robust rubber casing, light weight, and the added convenience of integrated noninvasive forehead thermometry, Rad-G with Temperature makes it easier for care teams to quickly measure vital signs using a single, compact, portable device and make informed decisions anywhere patient assessment is needed. Rad-G with Temperature is designed for use in a variety of settings, including physicians’ offices, outpatient services, urgent care facilities, wellness clinics, and in first-responder scenarios, both indoors and in the field.

Joe Kiani, Founder and CEO of Masimo, said, “With Rad-G, we set out to create an accessible, high-quality care solution that could be used in a multitude of care settings to serve the five billion people on our planet that to date have not had access to pulse oximetry, let alone SET^® pulse oximetry. With the addition of temperature measurements, Rad-G is more versatile than ever, streamlining the assessment of multiple key vital signs. Having a product that is light, small, multifunctional, and ‘accurate when you need it most’ is crucial, and Rad-G was designed to be just that. With this FDA clearance, Rad-G with Temperature can now be deployed across the U.S., in addition to many other parts of the world, helping support clinicians in almost any care scenario.” 

The infrared thermometry offered by Rad-G with Temperature provides a host of benefits. Rad-G’s thermometer is non-contact and does not require probe covers or other disposable accessories. Its integration into the Rad-G platform eliminates the need for clinicians to locate a separate clinical thermometer to take body temperature measurements and ensures that many people can be seamlessly and efficiently screened for temperature, with one-touch operation, alongside oxygen saturation, respiration rate, and more, in the same session, using a single device. Designed from the start to maximize portability and battery life, Rad-G’s rechargeable battery provides an impressive 24 hours of operational use between charges – allowing clinicians to work in transport, emergency, and other challenging scenarios with confidence that the device will continue to function hour after hour. 

First developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device for use in pneumonia screening, Rad-G with Temperature originally launched outside the U.S. Since its introduction in Europe, more than 100 global customers have adopted the device to help them assess patient status in a variety of care settings. Among other care scenarios, the National Health Service (NHS) England, which provides the majority of healthcare in England, uses the technology to support primary care assessments of unwell children in physician’s offices across the country. In a survey of 109 NHS England clinicians whose primary care facilities were using more than 4,000 Rad-G with Temperature devices, 85% of respondents scored Rad-G with Temperature as “Quite Easy” or “Very Easy” to use.¹

SpO₂ and PR monitoring on Rad-G is provided using clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other technologies.² SET^® is estimated to be used on more than 200 million patients a year³ and is the primary pulse oximetry at 9 of the 10 hospitals that top the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁴ With Masimo SET^® technology in Rad-G, clinicians have access to accurate pulse oximetry measurements in the palm of the hand.

In addition to temperature measurements and Masimo SET^® oxygen saturation (SpO₂) and pulse rate (PR), the same SpO₂ sensor can be used to monitor respiration rate from the plethysmograph, with RRp. Difficulty breathing and fever are generally considered two of the earliest signs of patient deterioration, and Masimo believes that the availability of RRp and thermometry on Rad-G may play a role in assisting clinicians and public health officials as they seek to combat numerous types of illnesses, including pneumonia and other respiratory viruses.

Rad-G with Temperature can be used with a variety of reusable and single-patient use sensors. The universal direct-connect Rad-G reusable sensor, indicated for monitoring adult, pediatric, and infant patients, helps to eliminate the need to stock and carry multiple sensor types, increasing the device’s versatility and ease of use, especially in more challenging field environments. Rad-G with Temperature is also compatible with the vast portfolio of Masimo single-patient-use adhesive sensors—including Masimo RD SET^® sensors, which offer best-in-class accuracy specifications of 1.5% in conditions of motion and no motion—ensuring clinicians can customize their setup based on the unique needs of each care setting. In addition, Rad-G is designed to work reliably on all people, regardless of skin tone, from neonates and babies to elderly patients.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,³ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁴ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Children and Young People Transformation Programme. Paediatric Pulse Oximeters Evaluation Report - July 2022. Provided to Masimo by NHS England.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Estimate: Masimo data on file.
4. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview
5. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
6. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
7. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
8. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
10. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo Rad-G^® with Temperature and SET^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo Rad-G with Temperature and SET^®, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Opioid Halo™ Granted De Novo for the First and Only FDA-Authorized Opioid Overdose Prevention and Alert System 

Opioid Halo Is Indicated for the Detection of Opioid-Induced Respiratory Depression, with Escalating Alarms to Alert Loved Ones That Help Is Needed

De Novo Authorizes Both Over-the-Counter (OTC) Use, on Adults and Children Age 15 and Up, and Prescription Use

Irvine, California - April 03, 2023 - Masimo (NASDAQ: MASI) today announced that Masimo Opioid Halo™, an opioid overdose prevention and alert system, has been granted a De Novo by the FDA – making it the first and only FDA-cleared monitoring solution for detecting opioid-induced respiratory depression, the leading cause of death from opioid overdose. With the De Novo, Masimo also becomes the first winner of an FDA Opioid Innovation Challenge to have an authorized solution designed to help solve the U.S. opioid crisis. The De Novo authorizes Opioid Halo to be made available over the counter (OTC) without a prescription, for use on adults and children age 15 and up, and an Rx version for use by prescription from a healthcare provider. Opioid Halo advances the forefront of continuous monitoring through its unique Opioid Halo engine, an advanced pattern recognition algorithm which helps detect and quantify the risk of severe opioid-induced respiratory depression. Combined with its innovative distributed architecture, Opioid Halo helps to manage and send escalating alarms to family members, friends, and caregivers, notifying them that help may be needed due to an opioid overdose – including triggering an automatic wellness call, which may lead to EMS being dispatched.

Joe Kiani, Founder and CEO of Masimo, said, “We are very excited to be able to offer this solution to our fellow Americans and the community heroes who are helping to battle the opioid crisis – a crisis so devastating in its impact on the young that it has lowered overall life expectancy in the U.S. Now, with Opioid Halo, we hope to help make a big difference by providing a much needed tool that can help millions, whether they are taking prescribed opioids or struggling with illicit opioid use. In 2018, we were honored to be chosen by the FDA, based on our expertise in patient monitoring technologies, to develop a device that could help prevent opioid overdose, as part of their Innovation Challenge addressing the opioid epidemic. And today, we are delighted to have received the first De Novo for our response to that Innovation Challenge, Masimo Opioid Halo. Between then and now, the COVID-19 pandemic accelerated our development and refinement of the Masimo SafetyNet^® family of remote patient management and telehealth solutions, helping save many COVID patients’ lives. We thank the FDA for taking on the opioid epidemic and granting this De Novo – a clearance that is a huge step forward in preventing overdose deaths and helping to end the opioid crisis.” 

Opioid overdose is the leading cause of accidental death in the US, responsible for more than 80,000 of the approximately 100,000 drug-related deaths in 2021, from both illicit opioids, such as fentanyl and heroin, and prescription opioids. Hundreds of thousands more suffer non-fatal overdose events, or the loss of a family member or friend to opioids.¹ Opioids are readily prescribed in the US, with more than 143 million opioid prescriptions written in 2020,² because they can be an effective way to help people manage pain, including after surgery or for chronic conditions. However, opioids also carry serious side effects, especially opioid-induced respiratory depression – slowed or stopped breathing – which is the leading cause of death from opioid overdoses.³ Anyone taking opioids, prescription or illicit, is at risk of experiencing an accidental overdose, the signs of which are unpredictable and can be difficult to detect. 

Masimo Opioid Halo is designed to help family and friends identify the symptoms of an opioid overdose by detecting physiological markers present during opioid-induced respiratory depression and ideally, helping them know when it’s time to intervene – for example, by administering a potentially life-saving dose of naloxone. Opioid Halo can be used at home or in the hospital or another care setting, by patients prescribed opioids after surgery or managing a chronic or prolonged condition, as well as people suffering from opioid use disorder.

The Opioid Halo system consists of four components: 1) a tetherless, adhesive fingertip sensor; 2) a reusable Masimo SET^® pulse oximeter and Bluetooth^® chip; 3) a Bluetooth-to-Wi-Fi Masimo Home Medical Hub; and 4) a smartphone app. The fingertip sensor provides real-time monitoring for opioid-induced respiratory depression, enabled by the Opioid Halo pattern recognition algorithm and Masimo SET^®, Signal Extraction Technology^® – even during movement, when hands are cold, and on all skin pigmentations. Data from the sensor and chip are wirelessly relayed to the Masimo Home Medical Hub and the smartphone app, which continuously analyzes the user’s physiological data for trends and patterns associated with the physiology of an opioid-induced respiratory depression event to quantify the risk of an opioid overdose. As the level of risk rises, the app and hub provide alerts. Upon early onset, an audible and visual alarm, designed to trigger early intervention opportunities for the user to self-recover or get help, is provided. If the Opioid Halo risk score continues to worsen, in addition to the repeated alarms, automatic texts are sent to designated friends and family members, letting them know it may be time to intervene, for example by administering naloxone or taking other action. Finally, if the severity of the risk level progresses even further, there is an optional setting that can be activated during setup that enables a service center to place an automatic wellness call to the user, the outcome of which may lead to EMS being dispatched.

Kim Bennion, MsHS, RRT, CHC, FAARC, System Director of Research for Respiratory Care Clinical Services at Intermountain Health, a 33-hospital system based in Salt Lake City, Utah, said, “Painkillers often called ‘opioids’ can have negative side effects, including opioid-induced respiratory depression. Intermountain Health has demonstrated that home monitoring of post-surgical patients receiving opioids for pain can help identify issues earlier and avoid adverse outcomes.  As a registered respiratory therapist and leader in the field of opioid-induced respiratory depression in the post-surgical setting, we are excited that Masimo’s breakthrough device will be available for our patients.”

Ryan Hampton, a noted advocate, author, and person in recovery, said, “Joe Kiani and his team at Masimo are strong advocates for solutions to help end the overdose crisis. Opioid Halo is another breakthrough innovation that can help save lives by adding to the critical support tools for people who use drugs.”

“My son Parker lost his life after taking prescription opioids to manage his pain after a tonsillectomy,” said Yvonne Gardner, now a patient safety advocate. “No one warned us that this could happen. This technology can help save other parents from losing a child.”

Masimo CEO Kiani added, “For more than 30 years, Masimo has been empowering clinicians with life-saving technologies that improve outcomes for countless patients around the world. Opioid Halo furthers our mission to expand beyond the hospital and into the home, empowering everyday people with a solution that we believe has the power to improve and save many more lives.”

For more information about Masimo Opioid Halo, and to pre-order it today for a loved one, a community hero, or an organization, visit opioidhalo.com.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹¹and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹² In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. https://www.cdc.gov/nchs/pressroom/nchs_press_releases/2022/202205.htm
2. https://www.cdc.gov/drugoverdose/rxrate-maps/index.html​​​​​
3. Schiller EY, Goyal A, Mechanic OJ. Opioid Overdose. [Updated 2022 Sep 19]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK470415/
4. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
5. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
6. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
7. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
8. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
10. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
11. Estimate: Masimo data on file.
12. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo Opioid Halo™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo Opioid Halo, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Unveils the Future of Smart Wearables with the Pre-Sale Launch of the Freedom™ Smartwatch

First of Its Kind Smartwatch Combines Masimo’s Accurate, Continuous Health Tracking Technology and Breakthrough Features in a Premium, Elegant Watch 

Masimo CEO Joe Kiani: “Freedom Will Revolutionize Wearable Technology and Health Tracking” 

Irvine, California - March 28, 2023 - Masimo (NASDAQ: MASI) a global leader in pulse oximetry and innovative noninvasive monitoring technologies, unveiled the newest addition to its wearable product line: the Masimo Freedom™ smartwatch. Developed to revolutionize the wearable technology industry, the Masimo Freedom smartwatch offers you the freedom to take control of your personal health and privacy through accurate and continuous health tracking, including a novel hardware feature designed to reduce radiation and free you from privacy infringement.

“We are thrilled to finally unveil Freedom,” said Joe Kiani, Founder and CEO of Masimo. “We believe that this groundbreaking new product will revolutionize wearable technology and health tracking. We are allowing people to take control of their health with continuous and accurate actionable biosensing information along with the convenience of being connected, but without compromising their freedom.”

The Masimo Freedom smartwatch builds on the success of the Masimo W1™ advanced biosensing watch by leveraging its state-of-the-art sensor and digital signal processing technology, enabling it to provide continuous, accurate, and reliable readings of key health data, like arterial blood oxygen saturation (SpO₂), hydration index (Hi™), pulse rate, heart rate, and respiration rate. The Freedom smartwatch seamlessly integrates Masimo’s cutting-edge health tracking technology into an elegant, user-friendly wearable with premium connectivity through Bluetooth^®, Wi-Fi, and LTE technologies, enabling the everyday conveniences of texting, calling, music, and third-party app compatibility. Masimo Freedom is an ideal companion for active individuals looking for better control of their day-to-day health and wellness data. Unlike other products on the market, Masimo Freedom features a physical privacy switch that instantly stops all data sharing beyond the device, including user data, as well as microphone, location, and metadata. 

The Masimo Freedom smartwatch utilizes technology based on Masimo SET^® pulse oximetry to optimize the capture of health data on the wrist. Masimo SET^®, co-invented by Joe Kiani, is the primary pulse oximetry technology used at 9 of the top 10 hospitals, as ranked in the 2022-23 U.S. News & World Report Best Hospitals Honor Roll,¹ and has been shown in over 100 studies to outperform other pulse oximetry technologies in clinical settings.²

In addition to Masimo Freedom, Masimo is also introducing a sleek, screenless band built on the innovations developed for Masimo W1 and Freedom. The band is designed to work in tandem and seamlessly synchronize with Freedom, so that you can wear one while charging the other – a 24/7 continuous wear ecosystem maximizing your ability to track your health both during the active day and at night while you sleep.

Consumers can pre-order Masimo Freedom now by placing a fully refundable $100 deposit, with expected shipping this fall. Masimo W1 is currently shipping. The Masimo band is expected to be ready for sale this summer. Those who would like to begin taking advantage of Masimo’s advanced biosensing technology now can purchase a Masimo W1 and automatically reserve their place in line to purchase Freedom with a $400 discount off the retail price. For more information about the Masimo family of wearables, and to order Masimo W1 and reserve your Masimo Freedom, visit freedom.masimoconsumer.com.

Masimo Freedom is not cleared for use in medical applications in the U.S.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo Freedom™ and Masimo W1™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo Freedom and W1, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

European Society of Anaesthesiology and Intensive Care (ESAIC) Recommends Noninvasive, Continuous Hemoglobin Monitoring

Technologies Like Masimo SpHb^® Offer a “Practical Approach” to Perioperative Blood Management and “Timely Detection of Changes” 

Neuchatel, Swirzerland - March 15, 2023 - Masimo (NASDAQ: MASI) today announced that updated guidelines published by the European Society of Anaesthesiology and Intensive Care (ESAIC) highlight the value of noninvasive, continuous hemoglobin (Hb) monitoring in helping clinicians manage perioperative bleeding. Referencing studies using technologies such as Masimo SpHb^®, the guidelines note that “the use of noninvasive Hb-monitoring methods may be a practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.”¹

Noting that in this area of care it is “essential to remain informed by the latest evidence,” the ESAIC, which has pledged to revisit its perioperative blood management guidelines at least every five years, has just published its updated findings, the result of a systematic review of research published from 2015 to 2021. Noting that managing bleeding during surgery is complex and “involves multiple assessment tools and strategies to ensure optimal patient care,” the guidelines cover numerous modalities, disciplines, scenarios, and patient populations – including how noninvasive, continuous hemoglobin monitoring offers a valuable way to improve blood management.

In the updated guidelines, the ESAIC notes a major drawback to measuring hemoglobin during surgery using blood gas analyzers and invasive blood sampling: “single measurements taken at different time points may not depict accurate values.” In addition, they note, excess blood sampling can lead to iatrogenic blood loss and hospital-acquired anemia. While noninvasive hemoglobin monitoring is not intended to replace invasive blood sampling, it may offer a “practical approach to monitor[ing] the Hb concentration continuously and without accumulating additional blood losses.” The guidelines also note its value “for trend analysis and to monitor changes in addition to laboratory-measured Hb concentrations during the intervals between invasive blood sampling and Hb measurements.” The guidelines continue, “Having access to continuous measurements of Hb concentrations offers timely detection of changes in Hb concentrations and adjustment, if necessary, in the clinical setting.”

In their summary of the guidance derived from their systematic literature review, the guidelines also note that when severe bleeding and volume shifts are expected or occurring, “continuous noninvasive haemoglobin monitoring may be considered for trend analyses and for reducing blood sampling for invasive laboratory measurement of haemoglobin concentration, especially in children.”

Launched in 2008, Masimo SpHb is part of the rainbow^® Pulse CO-Oximetry platform, available on a variety of Masimo Pulse CO-Oximeters^® and on devices from numerous third-party manufacturers, including Draeger, GE, Philips, and ZOLL. Utilizing multiple wavelengths of light, SpHb provides real-time, continuous visibility to changes in the hemoglobin trend between invasive blood samples. As part of patient blood management programs, SpHb has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,^2,3 reducing the units of red blood cells transfused per patient,^4-6 reducing the time to transfusion,⁷ reducing costs,⁸ and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi^®).⁹ The evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.^2-10 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.

Professor Kai Zacharowski, Ambassador and Immediate Past President of ESAIC and senior author of the guidelines, commented, “Noninvasive hemoglobin measurements now represent standard of care in many clinical scenarios. With their inclusion in the latest perioperative bleeding guidelines, we hope that more anesthesiologists and intensivists around the world incorporate this technology into their daily practice to help improve overall patient blood management.”

Professor Edoardo De Robertis, current President of ESAIC and co-author of the guidelines, noted, “The ESAIC holds the most prominent position in the community of anaesthesiologists and intensivists in Europe and elsewhere. We are pleased to share the updated guidelines with the goal of improving patient outcomes by focusing on the quality of care and patient safety strategies. Noninvasive hemoglobin monitoring has an important role throughout the perioperative period and in acute care, as it can provide trend data for more informed decision making. We look forward to seeing it adopted more widely for better patient care.”

Dr. William C. Wilson, Chief Medical Officer, Masimo, added, “With laboratory measurements, and even with bedside point-of-care hemoglobin testing, results are intermittent, sampling errors can occur, and performing these tests can be distracting during complex cases and while caring for critically ill patients. SpHb monitoring provides real-time visibility to hemoglobin levels throughout the continuum of care and has the advantages of trend analysis as well as reductions in workload and delay, enabling clinicians to adjust blood management and observe results simultaneously.”

Joe Kiani, Founder and CEO of Masimo, said, “Since its introduction 15 years ago, we’ve been heartened to see more and more clinicians around the world adopt SpHb as their standard of care, more and more clinical studies demonstrate its utility, and more and more esteemed organizations like ESAIC recognize the benefits of noninvasive hemoglobin monitoring. The result of years of development and continued refinement, powered by our expertise in advanced signal processing techniques, SpHb plays a critical role in our mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.”

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹² improve CCHD screening in newborns,¹³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^14-17 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Kietaibl S et al. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care. Eur J Anaesthesiol 2023; 40:226-304.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Nakamori E et al. Geriatr Orthop Surg Rehabil. 2021 Nov 19;12:21514593211060575.
4. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
5. Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
6. Saracoglu A, Abdullayez R, Sakar M, Sacak B, Incekoy F, Aykac Z. Continuous hemoglobin measurement during frontal advancement operations can improve patient outcomes. J Clin Mon Comp. 7 Mar 2022. https://doi.org/10.1007/s10877-022-00813-5.
7. Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
8. Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
9. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
10. Akdag S, Zengin SU, Cakmak G, Umuroglu T, Aykac ZZ, Saracoglu A. Targeted Bleeding Management Guided by Non-Invasive Haemoglobin Measurement in Surgical Patients. J Coll Physicians Surg Pak 2022; 32(10):1242-1248. 
11. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
12. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
13. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
14. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
15. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
16.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
17. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
18. Estimate: Masimo data on file.
19. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo SpHb^® and rainbow^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo SpHb and rainbow^®, contribute to positive clinical outcomes and patient safety;risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Finds That Masimo PVi^® Reliably Predicted Fluid Responsiveness in Young Children Undergoing Neurosurgery

Noninvasive, Continuous PVi Performed Well; Pressure-based Invasive Techniques Performed Poorly 

Neuchatel, Swirzerland - March 09, 2023 - Masimo (NASDAQ: MASI) today announced the findings of a prospective study published in Pediatrics International in which Dr. Ya-Fei Liu and colleagues at Peking University First Hospital in Beijing evaluated the ability of noninvasive, continuous Masimo PVi^®, alongside other dynamic parameters, to predict fluid responsiveness in children 1-3 years old who were undergoing major neurosurgery. The researchers concluded, “Volume-based PVi and ∆Vpeak [respiratory variation in aortic blood flow peak velocity] showed acceptable reliabilities for fluid responsiveness prediction in young children undergoing major neurosurgery, while pressure-based SVV [stroke volume variation] using FloTrac/Vigileo, Ea_dyn [dynamic arterial elastance], and PPV [pulse pressure variation] [did] not.”¹

Noting that dynamic variables have been shown to predict fluid responsiveness more accurately than static variables, and the critical importance of optimizing fluid administration in pediatric surgical patients, the researchers sought to evaluate and compare the performance of a variety of dynamic variables in such a scenario. The parameters evaluated were noninvasive, continuous PVi (pleth variability index, obtained from the photoplethysmographic waveform measured by fingertip pulse oximetry sensors and, in this study, the Masimo Radical-7^® Pulse CO-Oximeter^®), ∆Vpeak (obtained intermittently by Doppler echocardiography), SVV (measured by the Edwards Lifesciences FloTrac/Vigileo system), PPV (obtained from the peripheral arterial pressure waveform), and Ea_dyn (an index of arterial load). 

The researchers enrolled 60 patients, aged 1-3, who were undergoing major neurosurgery with mechanical ventilation set at a fixed tidal volume of 8 ml/kg. Following induction of anesthesia, during a hemodynamically stable period, the patients were administered 10 ml/kg of Ringer’s lactate solution, over 10 minutes; all variables were measured before and within five minutes of fluid loading. Patients with an increase in cardiac index (CI) of 10% or more were identified as a fluid responder. (CI was defined as stroke volume index multiplied by heart rate.)

The researchers identified 26 of the 60 patients as fluid responders. They found that baseline PVi showed “fair diagnostic accuracy” for CI-fluid responsiveness, with an area under the receiver operating characteristic curve (AUROC) of 0.775, p < 0.001. A baseline PVi cutoff value of 15% predicted CI-fluid responsiveness with 77% sensitivity and 68% specificity. Baseline ∆Vpeak was an “excellent predictor” of a CI increase, with AUROC of 0.982, p < 0.001, and a cutoff value of 9.6%. However, ∆Vpeak, which is dependent on the timing of echocardiograms, can only be obtained intermittently; the authors also note, as a practical drawback, that the limited availability of echocardiographic professionals “decreases its wide use in routine clinical settings.” The researchers found the other methods were either “poor” or “were not” predictors.

The researchers concluded, “Volume-based PVI and ∆Vpeak showed acceptable reliabilities to predict fluid responsiveness, defined by a CI increase, after anesthesia induction in mechanically ventilated young children undergoing major neurosurgery. However, pressure-based FloTrac/Vigileo-derived SVV, Ea_dyn, PI, PPV, and SVIc were not or [were] poorly reliable predictors. PVi’s noninvasiveness, continuity and acceptable predictability for fluid responsiveness could make it a potential aid in evaluating hemodynamic status, facilitating fluid administration, and developing optimal fluid management protocols in young children undergoing neurosurgery.”

Joe Kiani, Founder and CEO of Masimo, said, “From its inception, Masimo has focused on developing technologies that improve outcomes for the very youngest and most fragile of patients. This latest study on PVi – the second we are reporting on just this week! – adds to the body of evidence that PVi can help clinicians predict fluid responsiveness.”²

In the U.S., PVi is FDA 510(k) cleared as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Liu YF, Song LL, Ma W, Wang DX. Dynamic variables to predict fluid responsiveness in young children. Pediatrics International. 18 Jan 2023. DOI: 10.1111/ped.15477.
2. Published clinical studies on PVi can be found on our website at http://www.masimo.com.
3. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
6. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
10. Estimate: Masimo data on file.
11. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo PVi^® and Radical-7^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo PVi and Radical-7, contribute to positive clinical outcomes and patient safety;risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo and Temple Health Form Innovation Collaboration with Focus on Hospital Automation and Telehealth Initiatives

Researchers Found That Noninvasive, Continuous PVi Was Equally Effective in Guiding Fluid Management As Stroke Volume Variation (SVV), an Invasive Method Requiring an Arterial Line

Irvine, California and Philadelphia, Pennsylvaia - March 07, 2023 - Masimo (NASDAQ: MASI) a leading global provider of medical technology and automation solutions, and Temple Health, Philadelphia’s 979-bed academic health system, announced today that they are entering into a strategic innovation collaboration. With an emphasis on advancing the forefront remote patient monitoring and telehealth, as well as automating high-quality care, the collaboration may include the use of such innovations as the Masimo W1™ advanced health tracking watch, the Radius VSM™ tetherless, multimodal patient monitor, and Masimo Hospital Automation™ solutions like UniView^®, UniView :60™, Halo ION^®, and Sepsis Index™ for Patient SafetyNet™. The collaboration is designed to further the organizations’ mutual goals of improving health, increasing care value, and transforming models of care delivery.

Joseph DiMartino, MSN, RN, Associate Vice President of Nursing at Temple University Hospital, said, “Temple Health is committed to driving medical advances through clinical innovation, pioneering research and world-class education.  Our commitment aligns with Masimo’s vision for achieving tomorrow’s outcomes and helping institutions like ours improve and automate the ways we monitor physiological status across more care areas than ever before, as well as extend high-quality care beyond the hospital and into the home. We have collaborated with Masimo since 2008, starting with Masimo SET^® pulse oximetry, which has then expanded into other technology avenues that really help streamline clinical workflows and put our patients’ safety at the forefront. We are particularly excited by Masimo’s innovations in telehealth, remote patient monitoring, and automation, and how they can help us support improved outcomes for our patients both within and after they have left the hospital. The future is bright with Masimo as a technology partner.”

Joe Kiani, Founder and CEO of Masimo, added, “We are delighted to expand our relationship with Temple Health through this innovation collaboration, and to work hand in hand to explore how Masimo’s monitoring, connectivity, and automation technologies, alongside Temple Health’s clinical expertise, can bring safe, easy-to-use, high-quality telehealth and remote patient monitoring services to their patients. We are committed to improving life, improving patient outcomes, and reducing the cost of care.”

Temple Health and Masimo plan to collaborate in a number of areas, including:

• Demonstrating the future of healthcare, for the benefit of the broader healthcare ecosystem, through the deployment of next-generation technologies, therapies, devices, and systems designed to advance patient-centered care across the care continuum, and especially in the automation, remote patient monitoring, and telehealth space.
• Raising awareness of the importance of health equity by leveraging their expertise and regional influence to positively impact access to quality care for all Philadelphia residents.
• Participation in the Temple Health “Collaboratory,” where the latest Masimo technologies will be trialed and refined before broader deployment.
• Joint investigation of best practices for minimizing technology obsolescence in healthcare, a key focus as automation and telehealth infrastructure become more and more sophisticated.
• Clinical and technological exchanges between key leaders designed to advance the frontiers of healthcare.
• Joint clinical research opportunities in in-patient, out-patient, and home-based settings, with cooperation and co-development on technological innovations.

In the U.S., Masimo W1 as a medical device and Masimo Radius VSM are pending FDA clearance. Sepsis Index is not FDA cleared.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo W1™, Radius VSM™, Hospital Automation™, UniView^®, UniView :60™, Halo Index^®, Sepsis Index™, and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo W1, Radius VSM, Hospital Automation, UniView, UniView :60, Halo Index, Sepsis Index, and Patient SafetyNet; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks that Masimo may not realize the expected benefits and goals that may be achieved by its collaboration with Temple Health; risks that Masimo and Temple Health fail to collaborate in the areas stated in this press release as planned; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

About Temple Health

Temple University Health System (Temple Health) is a $2.4 billion academic health system dedicated to providing access to quality patient care and supporting excellence in medical education and research. Temple Health includes Temple University Hospital (TUH)-Main Campus; TUH-Episcopal Campus; TUH-Jeanes Campus; TUH-Northeastern Campus; Temple University Hospital – Fox Chase Cancer Center Outpatient Department; TUH-Northeastern Endoscopy Center; The Hospital of Fox Chase Cancer Center, together with The Institute for Cancer Research, an NCI-designated comprehensive cancer center; Fox Chase Cancer Center Medical Group, Inc., The Hospital of Fox Chase Cancer Center’s physician practice plan; Temple Transport Team, a ground and air-ambulance company; Temple Physicians, Inc., a network of community-based specialty and primary-care physician practices; and Temple Faculty Practice Plan, Inc., Temple Health’s physician practice plan. Temple Health is affiliated with the Lewis Katz School of Medicine at Temple University.

Temple Health refers to the health, education and research activities carried out by the affiliates of Temple Health and by the Katz School of Medicine. Temple Health neither provides nor controls the provision of health care. All health care is provided by its member organizations or independent health care providers affiliated with Temple Health member organizations. Each Temple Health member organization is owned and operated pursuant to its governing documents.

Non-discrimination notice: It is the policy of Temple University Hospital and The Hospital of Fox Chase Cancer Center, that no one shall be excluded from or denied the benefits of or participation in the delivery of quality medical care on the basis of race, ethnicity, religion, sexual orientation, gender, gender identity/expression, disability, age, ancestry, color, national origin, physical ability, level of education, or source of payment.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Temple Health
Christopher Guadagnino
Phone:(215) 707-7790
Email: [email protected]

New Study Evaluates the Use of Masimo PVi^® As an Indicator of Fluid Responsiveness to Guide Goal-Directed Fluid Therapy in Adult Neurosurgical Patients

Researchers Found That Noninvasive, Continuous PVi Was Equally Effective in Guiding Fluid Management As Stroke Volume Variation (SVV), an Invasive Method Requiring an Arterial Line

Neuchatel, Switzerland - March 6, 2023 - Masimo (NASDAQ: MASI)  today announced the findings of a prospective study published in the British Journal of Neurosurgery in which Dr. Ankita Dey and colleagues at institutions in Bathinda and Pondicherry, India evaluated the use of noninvasive, continuous Masimo PVi^®, as part of goal-directed fluid therapy (GDFT), to guide intraoperative fluid administration during neurosurgery – the first study to evaluate PVi in this surgical scenario – by comparing it to a parameter obtained invasively, stroke volume variation (SVV). The researchers concluded that “PVi and SVV are equally effective for guiding intraoperative goal-directed fluid therapy in adult neurosurgical patients scheduled for elective craniotomy for supratentorial brain tumors. However, PVi, being a noninvasive parameter, may be preferable.”¹. 

Noting the value of GDFT for neurosurgical patients in particular, but that most of the dynamic parameters traditionally used to guide GDFT, such as SVV, are invasive, requiring the use of an intra-arterial catheter (an arterial line, or “A-line”), which is associated with a variety of complications, the researchers sought to determine whether a noninvasive parameter, PVi, whose measurements are derived from the photoplethysmographic waveform, might serve as a reliable predictor of fluid responsiveness in such a population. PVi, or pleth variability index, is a measure of the variations in perfusion index over the respiratory cycle, and is indicated as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

To test their hypothesis, the researchers randomly divided 60 adult patients undergoing elective craniotomy into two groups: one whose intraoperative fluid administration was guided by PVi (n=29) and the other, by SVV (n=31). In the PVi group, patients were monitored using Masimo Radical-7^® Pulse CO-Oximeters^® with noninvasive pulse oximetry fingertip sensors. In the SVV group, SVV was invasively measured using an Edwards Lifesciences Vigileo/FloTrac device connected to a cannulated radial artery. The researchers compared the total amount of intravenous fluid administered during surgery, as well as serum lactate and serum creatinine levels at pre-determined time points, the brain relaxation score at dural opening and closure, and correlation between PVi and SVV values. They also compared duration of mechanical ventilation and length of hospital stay.

As noted in the table below, the researchers found that the volume of fluid administered intraoperatively was significantly higher in the SVV group. The other parameters and outcomes they measured were comparable between the two groups: serum lactate, serum creatinine, brain relaxation score, duration of mechanical ventilation, and length of hospital stay, as noted below. The researchers also observed “a moderate to strong correlation between SVV and PVi at corresponding points of time during the intraoperative period. This suggests that PVi, derived noninvasively from the pulse oximetry waveform, is a reliable indicator of fluid responsiveness.”

Outcome	PVi Group	SVV Group	p-Value
Volume of fluid administered	2139.3 ± 898.6 mL (mean)	3208.3 ± 1836.2 mL (mean)	0.005
Serum lactate level, over time	Ranging from 1.59 ± 0.91 to 2.73 ± 1.18	Ranging from 1.79 ± 0.97 to 2.44 ± 0.88	Ranging from 0.55 to 0.82
Serum creatinine level, over time	Ranging from 0.64 ± 0.14 to 0.66 ± 0.15 mg/dL	Ranging from 0.64 ± 0.17 to 0.71 ± 0.21 mg/dL	Ranging from 0.23 to 0.86
Brain relaxation score	2 (1-3) at dural opening, 2 (12) at dural closing (median)	2 (1-4) at dural opening and closing (median)	0.49 (opening) 0.33 (closing)
Duration of mechanical ventilation	19.09 ± 15.9 hours (mean)	27.9 ± 15.9 hours (mean)	0.1
Length of hospital stay	12.6 ± 19.26 days (mean)	16.4 ± 26.8 days (mean)	0.53

 

The researchers concluded, “Based on the findings of our study, we conclude that PVi and SVV are equally effective for guiding intraoperative goal directed fluid therapy in adult neurosurgical patients scheduled for elective craniotomy for supratentorial brain tumors. However, PVi, being a noninvasive parameter, may be preferable.” They continued, “The two groups in our study were comparable with respect to serum creatinine and serum lactate measured at predetermined time points intraoperatively and post operatively. The two groups were also comparable with respect to brain relaxation scores at dural opening and dural closure. There was moderate to strong correlation between SVV and PVi at corresponding time points intraoperatively. The duration of mechanical ventilation and the length of hospital stay was also comparable between the two groups.”

Joe Kiani, Founder and CEO of Masimo, said, “We introduced PVi in 2007. It was the first and still is the only noninvasive way of measuring fluid responsiveness in mechanically ventilated patients at a fraction of the cost of invasive methods and without risk of invasive procedures to the patient.  Since then, over 100 studies have shown that PVi or PVi in combination with our noninvasive hemoglobin technology, SpHb^®, has made a tremendous contribution to patient care.² This latest study adds to the evidence that PVi can be used to help clinicians manage the fluid levels of their patients without invasive catheters.”

In the U.S., PVi is FDA 510(k) cleared as a noninvasive dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients. Accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure and device related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Dey A, Bidkar PU, Swaminathan S, Kumari M, Joy JJ, Balasubramanian M, Bhimsaria S. Comparison of two techniques of goal-directed fluid therapy in elective neurosurgical patients – a randomized controlled study. Br J Neuosurgery. 3 Feb 2023. DOI: 10.1080/02688697.2023.2173722/
2. Published clinical studies on PVi can be found on our website at http://www.masimo.com.
3. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
6. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
10. Estimate: Masimo data on file.
11. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo PVi^®, SpHb^®, and Radical-7^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo PVi, SpHb, and Radical-7, contribute to positive clinical outcomes and patient safety;risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Evaluates the Utility of Masimo ORi™ in Reducing Hyperoxemia During Laparoscopic Gastrectomy

Researchers Found That Using ORi with SpO₂ to Help Guide Supplemental Oxygen Delivery Reduced Intraoperative Hyperoxemia 

Neuchatel, Switzerland - February 21, 2023 - Masimo (NASDAQ: MASI) today announced the findings of a prospective, double-blinded, randomized controlled study published in Medicine in which Dr. Jin Hee Ahn and colleagues at the Sungkyunkwan University School of Medicine in Seoul, Korea evaluated the ability of Masimo ORi™ to assist clinicians in guiding supplemental oxygenation during elective laparoscopic gastrectomy surgery. The researchers found that the combination of ORi and standard of care oxygen saturation (SpO₂) monitoring reduced hyperoxemia compared to SpO₂ monitoring alone.¹ 

ORi, available outside the U.S. since 2014, is a noninvasive and continuous parameter intended to provide additional insight into a patient’s oxygen status under supplemental oxygen. Enabled by the multi-wavelength rainbow^® Pulse CO-Oximetry platform, ORi is provided alongside SpO₂ measured by clinically proven Masimo SET^® pulse oximetry.

Noting that the use of supplemental oxygen during general surgery increases the risk of hyperoxemia, the researchers sought to evaluate whether noninvasive, continuous ORi might improve clinicians’ ability to detect hyperoxemia, since SpO₂ monitoring alone cannot monitor beyond 100% saturation, and since arterial blood gas analysis has the disadvantages of being invasive and giving intermittent, delayed results. To test their hypothesis, the researchers randomly allocated 62 adult patients scheduled for elective laparoscopic gastrectomy into two groups, one whose fraction of inspired oxygen (FiO₂) during anesthesia was guided by ORi and SpO₂ monitoring (the ORi-SpO₂ group, n=30), and a control group whose FiO₂ was guided by SpO₂ monitoring alone (the SpO₂ group, n=32). Patients in both groups were monitored with Masimo Radical-7^® Pulse CO-Oximeters^® with rainbow^® sensors. In addition to Masimo ORi and SET^® SpO₂, Masimo PVi^® (pleth variability index) was monitored as part of goal-directed fluid management. 

In the ORi-SpO₂ group, FiO₂ was adjusted to maintain ORi > 0 and < 0.3, which was evaluated every 2 to 3 minutes throughout surgery. In the SpO₂ group, FiO₂ was adjusted to maintain SpO₂ ≥ 98%, similarly evaluated every 2 to 3 minutes. To assess the incidence of hyperoxemia, the clinicians recorded the arterial partial pressure of oxygen (PaO₂), measured using an ABL-90 FLEX Plus blood gas analyzer, before surgical incision and one, two, and three hours after surgical incision. Hyperoxemia was defined as PaO₂ ≥ 100 mmHg and severe hyperoxemia as PaO₂ ≥ 200 mmHg.

The researchers found that one hour after surgical incision, PaO₂ was higher in the SpO₂ group (250.31 ± 57.39 mmHg) than in the ORi-SpO₂ group (170.07 ± 49.39 mmHg) (p < .001), and remained consistently higher in the SpO₂ group than in the ORi-SpO₂ group over time (p = .045). The rate of severe hyperoxemia was higher in the SpO₂ group (84.4%) than in the ORi-SpO₂ group (16.7%) 1 hour after incision (p < .001).

The researchers concluded, “[I]ntraoperative hyperoxemia was reduced when FiO₂ was adjusted based on the combination of SpO₂ and ORi compared with SpO₂ alone in patients undergoing laparoscopic gastrectomy.”

ORi has not yet received FDA clearance and is not available in the United States.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Ahn JH, Shim J-G, Park J, Lee SH, Ryu K-H, Cho E-A. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine. October 2022. DOI: 10.1097/MD.0000000000031592.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness ofMasimo ORi™, SET^®, rainbow^®, and Radical-7^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimo ORi, SET^®, rainbow^®, and Radical-7, contribute to positive clinical outcomes and patient safety;risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Centroid^® Receives Innovative Technology Designation from Vizient 

The Vizient Designation, for Masimo’s Wearable, Wireless Patient Position, Orientation, and Activity Sensor, Recognizes Products That Bring Improvements to the Healthcare Industry

Irvine, California - February 15, 2023 - Masimo (NASDAQ: MASI) today announced that Centroid^®, a wearable, wireless patient orientation and activity sensor, has received an Innovative Technology designation from Vizient, Inc., the largest healthcare performance improvement company in the United States. Masimo exhibited Centroid in combination with the Masimo Root^® Patient Monitoring and Connectivity platform at the Vizient Innovative Technology Exchange held in Dallas last October.

Every year, healthcare experts serving on Vizient member-led councils review select products and technologies for their potential to enhance clinical care, patient safety, healthcare worker safety or to improve business operations of healthcare organizations. Innovative Technology designations are awarded to previously contracted products to signal to healthcare providers the impact of these innovations on patient care and business models of healthcare organizations.

Masimo Centroid is designed to help clinicians monitor patient position to avoid hospital-acquired pressure injuries (HAPIs) – which affect nearly 2.5 million patients in the U.S. each year, of whom nearly 60,000 die as a direct result¹ – and can alert clinicians to sudden movements such as fall-like events. In addition, Centroid detects chest movements to continuously provide respiration rate, assisting clinicians with additional data to help them make more informed care decisions. Centroid pairs with Root using Bluetooth^® to track a patient's posture, orientation, and activity, providing the ability to monitor patient position and detect changes in position. The data transmitted by Centroid can be displayed in various formats on Root, giving clinicians multiple ways to assess adherence to protocols regarding tissue stress and to tailor care to the specific needs of each patient. 

In addition, Centroid data can be relayed via the Masimo Hospital Automation™ platform to Patient SafetyNet™, Masimo’s centralized remote patient supplemental monitoring platform, and Replica^®, a mobile application that allows clinicians to view continuous data regardless of location. Moreover, connectivity to the Masimo Hospital Automation platform allows clinicians to automate the charting of patient turns in electronic medical records (EMRs), as well as run reports and analytics, helping to direct resources and drive continuous improvement in turn protocol adherence.

HAPIs are on the rise, occurring in nearly 5% of all hospitalized patients in the U.S.¹ Elderly and critically ill patients are often at highest risk for developing a HAPI, which can lead to further treatments and extended lengths of stay in the hospital. To compound the patient impact associated with these pressure injuries, there is a major economic burden for the hospital as well. Pressure injuries are classified as a hospital-acquired condition (HAC), and the treatment costs associated with HACs are non-reimbursable to the hospital. One pressure injury can quickly add up to tens of thousands of dollars in excess patient care expenses. Many facilities in the US spend millions each year treating these wounds.² Pressure injuries are also a reportable quality metric to CMS.³

According to the National Pressure Injury Advisory Panel (NPIAP), scheduled turning protocols are known to prevent HAPIs, yet most U.S. hospitals still use techniques such as paper wall clocks or egg timers – methods proving to be ineffective and archaic in modern healthcare – to try and optimize this practice.⁴ Staffing issues and competing priorities have strained nurses, and staying on top of when a patient was last turned is difficult without a more sophisticated system – such as Masimo Centroid.

Bilal Muhsin, Chief Operating Officer of Masimo Healthcare, said, “We are honored that Vizient has selected Centroid for its Innovative Technology designation. Centroid takes advantage of our many years of experience developing advanced monitoring technologies, algorithms, and automation solutions to provide a streamlined and powerful way to help hospitals track patient position from moment to moment. Many thanks to the Vizient council for recognizing our commitment to helping improve patient outcomes, reduce the cost of care, and improve life.”

“A product receives this designation when it has a unique quality that differentiates it from its competitors,” said Kelly Flaharty, Vizient Senior Director of Contract Services. “Our member council determined that Centroid met this standard and recognizes its potential to improve quality outcomes.”

Vizient represents a diverse membership that includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute healthcare providers and represents approximately $130 billion in annual purchasing volume. Through its Innovative Technology Program, Vizient works with member-led councils and task forces to evaluate products for their potential to bring real innovation to healthcare. Vizient may award a contract to products deemed worthy of the Innovative Technology designation outside of the competitive bid cycle. 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.⁵ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁶ improve CCHD screening in newborns,⁷ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^8-11 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹² and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹³ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3217823
2. https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/Value-Based-Programs/HAC/Hospital-Acquired-Conditions 
3. https://pubmed.ncbi.nlm.nih.gov/30693644/
4. https://cdn.ymaws.com/npiap.com/resource/resmgr/white_papers/1i._pressure_ulcers_in_indiv.pdf 
5. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
6. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
7. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
8. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
9. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
10.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
11. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
12. Estimate: Masimo data on file.
13. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Centroid^®, Root^®, Replica^®, Hospital Automation™, and Patient SafetyNet™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, includingMasimoCentroid, Root, Replica, Hospital Automation, and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks that Masimo does not realize the expected benefits of being awarded the Innovative Technology designation by Vizient; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo Announces the Limited Market Release of Visual Clinical Activity Monitoring (VCAM^™) 

AI-Based Video Analysis System Promotes Hand Hygiene Compliance, Integrates with Masimo Hospital Automation^™ Platform

Irvine, California - January 30, 2023 - Masimo (NASDAQ: MASI) today announced the limited market release of Visual Clinical Activity Monitoring (VCAM^™), a video analysis system that uses artificial intelligence to help facilitate compliance with hospital hand hygiene protocols. VCAM, which integrates seamlessly with the Masimo Hospital Automation^™ platform of solutions, including Masimo Patient SafetyNet^™, Replica^®, and Root^®, is designed to help hospitals and other care facilities optimize protocol adherence, with real-time notifications at the point-of-care about current hand hygiene status and powerful analytics around protocol compliance – with the ultimate goal of helping institutions decrease the incidence of hospital-acquired infections (HAIs).

Hand hygiene is well known to be an important factor in infection control activities, with numerous studies showing that washing one’s hands is the “single most important, simplest, and least expensive means of reducing the prevalence of HAIs and the spread of antimicrobial resistance.”¹ A recently published study conducted across multiple sites over eight years in Finland, for example, found a direct correlation between increased compliance with hand hygiene protocols and decreased incidence of HAIs.² However, in the absence of “active” hand hygiene initiatives – programs, for example, designed to measure and automate compliance – the compliance rate with such protocols rarely exceeds 40% in hospitals and other healthcare institutions.¹ 

Masimo VCAM, powered by Masimo’s expertise in AI-enabled algorithms and based on each facility’s standards, makes it easier for hospitals to optimize staff adherence to hand hygiene protocols by providing notifications on the spot, tracking compliance, and automating reporting. VCAM detects when clinicians are performing hygiene activities, such as washing hands or using an alcohol-based sanitizer, and identifies when they interact with people and objects, as well as when they touch or pick up an object from a potentially unclean surface such as the floor. Immediate notifications about current hygiene status are relayed to individual clinicians on bedside Root monitors and on Replica-equipped smartphones, prompting them, for example, to wash or sanitize their hands when they may have neglected to do so. In turn, VCAM’s rich reporting capabilities provide detailed analysis, such as the rates of clean vs. dirty incidents (which can be filtered by room and by department), helping leadership target opportunities for workflow improvements. 

Vijay Dhar, MD, Chief of Neonatology at Children’s Hospital of Orange County (CHOC), California, said, “We, at CHOC, are eagerly anticipating the deployment of Masimo VCAM, the innovative artificial intelligence (AI) system that can characterize hand hygiene compliance. We hope VCAM will be able to help us to decrease hospital-acquired infections (HAIs), including viral pathogens such as respiratory syncytial virus (RSV), bacterial organisms such as MRSA, and other nosocomial organisms responsible for central line associated blood stream infections (CLABSI), the most common form of nosocomial infection affecting neonates. With Masimo VCAM helping us maintain hand hygiene, we aim to diminish these totally preventable HAIs and improve the safety and wellbeing of our neonates.” 

Joe Kiani, Founder and CEO of Masimo, said, “VCAM adds an important new tool to the growing Masimo ecosystem of Hospital Automation products, building on our experience developing breakthrough algorithms and next-generation connectivity solutions, to help streamline hospitals’ ability to meet compliance goals with as fundamental and critical a task as hand-washing. VCAM aligns with our continued mission to improve patient outcomes, reduce the cost of care, and ultimately, improve life.”

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹¹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature. 

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Mathur P. Hand hygiene: back to the basics of infection control. Indian J Med Res. 2011 Nov;134(5):611-20.
2. Ojanperä H, Ohtonen P, Kanste O, Syrjälä H. Impact of direct hand hygiene observations and feedback on hand hygiene compliance among nurses and doctors in medical and surgical wards: an eight-year observational study. J Hosp Infect. 2022 Sep;127:83-90.
3. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
6. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
10. Estimate: Masimo data on file.
11. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

 

 

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo VCAM^™, Hospital Automation^™, Patient SafetyNet^™, Replica^®, and Root^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo VCAM, Hospital Automation, Patient SafetyNet, Replica, and Root, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Researchers Harness the Power of Masimo Root^®’s Advanced Multimodal Monitoring Capabilities to Study the Impact of Different Ventilatory Strategies on Brain Oxygenation During Thoracoscopic Surgery

Simultaneous Use of Masimo O3^® Regional Oximetry, NomoLine^® Capnography, SedLine^® Brain Function Monitoring, and rainbow^® Pulse CO-Oximetry Helped Clinicians Determine that Maintaining Higher End-tidal Carbon Dioxide (EtCO₂) Improved Cerebral Oxygenation, Leading to Improved Outcomes

Neuchatel, Switzerland - January 23, 2023 - Masimo (NASDAQ: MASI) today announced the findings of a prospective, single-blinded, randomized controlled study published in the Journal of Anesthesia & Intensive Care Medicine in which Dr. Mona Mohamed Mogahed and colleagues at Tanta University in Tanta, Egypt and The King Fahd General Hospital in Jeddah, Saudi Arabia, sought to evaluate the impact of varying ventilation strategies on the cerebral oxygenation of patients undergoing video-assisted thoracoscopic surgery (VATS). To monitor the variety of physiological parameters needed to undertake such an evaluation, they turned to the multi-modal Masimo Root^® patient monitoring and connectivity platform, which is designed to allow clinicians to streamline their ability to keep track of numerous modalities, simultaneously, using a single, intuitive monitor. The technologies involved included O3^® regional oximetry, capnography with NomoLine^® sampling lines, SedLine^® brain function monitoring, and multiple rainbow^® Pulse CO-Oximetry measurements. Using Root and Masimo monitoring technologies, the researchers were able to determine that maintaining higher end-tidal carbon dioxide (EtCO₂) improved baseline regional cerebral oxygenation (rSO₂), with impacts on early postoperative cognitive function that included improvements in Aldrete scores and mini mental status exam (MMSE) scores.¹ 

Noting the increased risk of hypoxemia during one-lung ventilation (OLV) as part of VATS, which can lead to postoperative neurocognitive dysfunctions, the authors hypothesized that increasing EtCO₂ could be a “convenient and powerful” way to manage cerebral desaturation during the surgery. They enrolled 70 patients, ages 18-65, undergoing elective VATS requiring OLV, between September 2021 and September 2022 at The King Fahd General Hospital, Jeddah. All patients were operated on by the same surgical team. The patients were randomly divided into two groups: in the first, EtCO₂ was maintained at 32-38 mmHg (group I) and in the second, at 39-45 mmHg (group II). During the procedure, monitored parameters included oxygen saturation (Masimo SET^® SpO₂), heart rate (HR), and noninvasive hemoglobin (Masimo SpHb^®) via an RD rainbow SET^® fingertip sensor; EtCO₂ via capnometer and NomoLine sampling line; noninvasive blood pressure (NIBP), body temperature, and rSO₂ via O3 near-infrared spectroscopy (NIRS) sensors monitoring both brain hemispheres; and Masimo Patient State Index (PSi^™), a processed EEG parameter used to help clinicians maintain appropriate sedation, via SedLine. Outcomes included Aldrete scores and MMSE scores assessed at 3 and 24 hours after surgery.

The researchers found that the percentage of change in rSO₂ differed significantly between groups (p < 0.05), on both sides of the brain, with the higher values, over time, in Group II, in direct relation with the higher EtCO₂ maintained in that group. In the right hemisphere, the difference became significant at the fourth time interval [T4] at which rSO₂ was recorded, p = 0.0012, and maintained significance for the remainder of surgery [T4-T13], p < 0.001. In the left hemisphere, the difference became significant at T2, p = 0.09, and remained significant [T3-13], p < 0.001. Aldrete scores were significantly higher in Group II upon arrival at the post-anesthesia care unit (PACU) (p = 0.013) and 15 minutes after arrival (p = 0.03), then became comparable. MMSE scores were significantly higher in Group II 3 hours after surgery (p = 0.0009), but not at 24 hours after surgery.

The researchers concluded, “Adjusting the ventilator parameters to develop EtCO₂ of 39-45 mmHg improved cerebral oxygenation more than EtCO₂ of 32-38 mmHg, that play[s] a protective role in the brain, causing significant impact on the early postoperative cognitive function in patients with OLV undergoing VATS.” Regarding the use of Masimo Root and associated monitoring technologies, they noted that they “preferred using it as it can display several clinical measurements [at] the same time, such as HR, BP, temperature, SpO₂, EtCO₂, PSi, and rSO₂.”

 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion^™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet^™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC^™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi^™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA^™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM^™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation^™ platform, and include Iris^® Gateway, iSirona^™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60^™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1^™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Mogahed MM, Alnoamani TS, Elkahwagy MS. The Ventilatory Influence on Cerebral Oxygenation in Patients Undergoing Video Assisted Thoracoscopic Surgery. J Anest & Inten Care Med. 12(3). December 2022. DOI: 10.19080/JAICM.202212.555837.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO₂ Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

 

 

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Root^®, O3^®, NomoLine^®, SedLine^®, rainbow^®, RD rainbow SET^®, SpHb^®, SET^®, and PSi^™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Root, O3, NomoLine, SedLine, rainbow, RD rainbow SET, SpHb, SET^®, and PSi, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Masimo and Philips Expand Partnership to Improve Telehealth for Patients and Clinicians Around the World with the Masimo W1™ Watch

Breakthrough Combination of the Masimo W1 Watch with Advanced Philips Solutions Will Become Available for Home Telehealth Applications 

Irvine, California - January 18, 2023 - Masimo (NASDAQ: MASI) and Royal Philips (NYSE: PHG, AEX: PHIA) today announced an expansion of their partnership to augment patient monitoring capabilities in home telehealth applications with the Masimo W1™ advanced health tracking watch. The W1 will integrate with Philips’s enterprise patient monitoring ecosystem to advance the forefront of telemonitoring and telehealth. The combined innovation, which draws upon the two global medical technology leaders’ extensive expertise in monitoring, connectivity, and automation, will be highlighted later this month at Arab Health 2023. 

Masimo W1 is the first watch to offer accurate, continuous pulse oximetry measurements and other insightful health data. Using Masimo’s secure health data cloud, patient information will be relayed to the Philips patient monitoring ecosystem for remote clinician surveillance. Hospital clinicians will be able to seamlessly and remotely monitor key health markers as their patients move throughout their homes and go about their daily lives. Physicians will be able to more confidently discharge patients knowing that their vital signs will still be monitored (via Masimo W1) and their physiological status tracked (via Philips dashboards), helping them catch possible patient deterioration sooner and make more informed interventions. This breakthrough combination of monitoring and connectivity technologies will enable numerous opportunities supporting early discharge initiatives, hospital-at-home programs, and chronic illness management.

Bilal Muhsin, Chief Operating Officer of Masimo Healthcare, said, “Expanding our partnership with Philips in this way is a win-win for patients and clinicians everywhere, and is an important part of our multi-year plan to bring the best of hospital monitoring to the home while continuing to improve access to quality hospital care.”

“At Philips, we believe in an open ecosystem of information that enables physicians in their daily routine, allows for them to access and process vital patient information and deploy a wide range of measurements and patient-worn technologies,” added Christoph Pedain, General Manager, Hospital Patient Monitoring at Philips. “Our integration of the latest Masimo technologies is a testament to that strategy and we are delighted to deepen our relationship with Masimo.”   

Masimo W1 for use in medical applications is CE marked and is pending FDA clearance.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

About Royal Philips

Royal Philips (NYSE: PHG, AEX: PHIA) is a leading health technology company focused on improving people's health and well-being, and enabling better outcomes across the health continuum – from healthy living and prevention, to diagnosis, treatment and home care. Philips leverages advanced technology and deep clinical and consumer insights to deliver integrated solutions. Headquartered in the Netherlands, the company is a leader in diagnostic imaging, image-guided therapy, patient monitoring and health informatics, as well as in consumer health and home care. Philips generated 2021 sales of EUR 17.2 billion and employs approximately 78,000 employees with sales and services in more than 100 countries. News about Philips can be found at www.philips.com/newscenter.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo W1™. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo W1, contribute to positive clinical outcomes and patient safety; risks that Masimo may not realize the expected benefits and goals that may be achieved by its partnership with Philips and the combined innovation; risks that the combined innovation of Masimo and Philips may not be highlighted at Arab Health 2023; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Masimo
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

Philips
Meredith Amoroso
Phone:(724) 584-8991
Email: [email protected]

ITC Judge Rules Apple Violated U.S. Trade Laws by Infringing Masimo Pulse Oximeter Patent 

Irvine, California - January 10, 2023 - A United States Administrative Law Judge in Washington, D.C. ruled that Apple Inc. (Nasdaq: AAPL) violated Section 337 of the Tariff Act of 1930 as amended, by importing and selling within the United States certain Apple Watches with light-based pulse oximetry functionality and components, which infringe one of Masimo's (Nasdaq: MASI) pulse oximeter patents. Apple first released its pulse oximeter sensor with the Apple Watch Series 6 in 2020 and continues to use it in the current Apple Watches. The United States International Trade Commission (USITC) will now consider whether to implement a ban on imports of these Apple Watches. 

“We are happy that the ALJ recognized Apple’s infringement of Masimo’s pulse oximetry technology and took this critical first step toward accountability,” said Joe Kiani, CEO of Masimo.  “Today’s decision should help restore fairness in the market. Apple has similarly infringed on other companies’ technologies, and we believe today’s ruling exposes Apple as a company that takes other companies’ innovations and repackages them.”

Masimo is the global leader of pulse oximeters for medical use, having revolutionized the industry with its Masimo SET® pulse oximetry technology, proven to help reduce blindness in babies in the neonatal intensive care unit, save lives of post-surgical patients on opioids and COVID patients monitored remotely. Masimo recently debuted its own watch – the Masimo W1™ – which is the first wearable device on the market to provide consumers with accurate, continuous health data, including oxygen level, hydration index, and pulse, heart, and respiration rates

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.⁹ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
2. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
3. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
4. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
7. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
8. Estimate: Masimo data on file.
9. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Evaluates the Performance of Masimo SpHb^® Noninvasive Spot-Check Hemoglobin in the Emergency Department

Masimo SpHb on the Handheld Masimo Rad-67^® Demonstrated “Acceptable Accuracy and Excellent Correlation” with Laboratory Hemoglobin

Neuchatel, Switezerland - January 09, 2022 - Masimo (NASDAQ: MASI) today announced the results of a prospective study published in the American Journal of Emergency Medicine in which Dr. Zohair Ahmed Ali Al Aseri and colleagues at King Saud University Medical City and Dar Al Uloom University (Riyadh, Saudi Arabia) evaluated the performance of noninvasive spot-check hemoglobin measurement with Masimo SpHb^® on emergency department (ED) patients. The researchers found that SpHb provided “acceptable accuracy and excellent correlation” with their invasive laboratory measurements and offers an “easy, quick, feasible, cheap, and accurate solution for Hb measurement in the ED.”¹

Noting that invasive blood hemoglobin measurement, while an important step in the management of blood loss, has drawbacks such as “consumption of valuable time, phlebotomy-induced anemia, pain, infection, and more involvement of human resources and equipment,” the authors sought to evaluate whether a noninvasive modality might offer similarly accurate results while mitigating some of these factors. To compare noninvasive and invasive measurements, they enrolled 650 patients (age > 14 years) who visited the EDs of two hospitals within King Saud University Medical City between March and May 2022 and needed complete blood count measurements. Hemoglobin was noninvasively measured (SpHb) using the Masimo Rad-67^® handheld Pulse CO-Oximeter^® with the DCI^®-mini fingertip sensor. Simultaneously, blood samples were collected and analyzed at the time of collection (LabHb) using their automated analyzer, a UniCel DxH 800 Coulter Cellular Analysis System.

The researchers found a “highly significant correlation” between SpHb and LabHb (Pearson correlation coefficient = 0.812, p < 0.01). Bland-Altman analysis revealed low mean bias of 0.146 g/dL ± 1.39 g/dL, with moderate limits of agreement (-2.58 and 2.87 g/dL) and a margin of error (95% confidence interval) of 2.7 g/dL. 

The researchers concluded that “noninvasive hemoglobin (SpHb) measurement showed acceptable accuracy and excellent correlation with LabHb and provided an easy, quick, feasible, cheap, and accurate solution for Hb measurement in the ED. Further research is required to study its effects on patient outcomes and blood transfusion and time and cost effectiveness.”

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples. 

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Al Aseri ZAA, Aldawood BA, Altamimi et al. Accuracy of noninvasive hemoglobin level measurement in the emergency department. Amer J Emerg Med. DOI: 10.1016/j.ajem.2022.11.012.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Study Finds That Masimo Patient SafetyNet™ Helped Clinicians Reduce CPR Events and Rates, Improve CPR Success Rate, and Reduce Hospital Length of Stay and Mortality

Neuchatel, Switzerland - January 5, 2023 - Masimo(NASDAQ: MASI) today announced the findings of a before-and-after study published in PLoS ONE in which Dr. Ahmed Balshi and colleagues at King Saud Medical City in Riyadh, Saudi Arabia, evaluated the impact of implementing remote patient monitoring with Masimo Patient SafetyNet™ on the efficacy of hospital rapid response teams (RRTs). Comparing outcomes before and after implementation of Patient SafetyNet, they found that the “after” group experienced more RRT activations but had significantly lower incidence and rate of cardiopulmonary resuscitation (CPR), significantly shorter hospital length of stay (LOS), and lower hospital mortality.¹

Noting that RRT activation depends on the “timely detection of [patient] deterioration,” the researchers sought to determine whether a remote patient surveillance system that automated calculation and relaying of early warning scores could lead to earlier recognition of changes in patient status and the improved efficacy of RRTs. They hypothesized that implementing such a system could decrease the rate of severe adverse events, as a result of potentially quicker RRT activation. To that end, they designed a “before” and “after” study at a large government hospital (1,200 inpatient beds) in central Saudi Arabia where the ICU provides outreach, in the form of an RRT, to the general ward. 

In the “before” period (retrospective data) nurses manually recorded patient vital signs, calculated warning scores, and activated RRTs; in the “after” period” (prospective data), vital signs data collected at the bedside, alongside automatically calculated warning scores, were wirelessly relayed to nursing stations for centralized remote patient surveillance and RRT activation. Both before and after, activation of an RRT was triggered when a patient’s vital signs deteriorated to the point they scored ≥ 5 on the MEWS (Modified Early Warning Score) scale. “Before” group data was analyzed from 2,346 adult patients from January to August 2020, and “after” group data from 2,151 patients from September 2020 to April 2021. For the “after” group, Masimo Patient SafetyNet was used to automate transfer of bedside monitoring data to central nursing stations, with alarm and notification data also relayed to clinicians’ smartphones using Masimo Replica^®.

The researchers found that in the “before” group, there were 78 episodes of CPR over 20,510 total inpatient days, for an incidence of 3.3% and rate of 3.8 per 1000 inpatient days (95% confidence interval: 3 – 4.7 episodes). In the “after” group, there were 42 episodes over 17,945 inpatient days, for an incidence of 1.95% and rate of 2.3 per 1000 inpatient days (95% CI: 1.7 – 3.2). CPR incidence in the “after” group was significantly lower (p = 0.01). In addition, the CPR success rate was significantly higher in the “after” group (before: 38.5% vs. after: 59.5%; p = 0.04). The average hospital LOS was higher in the “before” group (before: 8.7 days ± 3.4 days vs. after: 8.3 days ± 3 days; 95% CI of the difference: 0.2 – 0.6 days; p < 0.001). The number of RRT activations was lower in the “before” group (before: 20 ± 7 vs. after: 23.7 ± 9.4; 95% CI of the difference: 3.2 – 4.2; p < 0.001). Overall hospital mortality was lower in the “after” group (before: 5.45% vs. after: 4%; 95% CI: 0.6 - 2.2; p < 0.001). Using multivariable logistic regression, they calculated that being in the “after” group decreased a patient’s odds of needing CPR by 33% (odds ratio: 0.67; 95% CI: 0.46 – 0.99; p = 0.04).

The investigators concluded, “Automated activation of the RRT by Masimo Patient SafetyNet applied to medical ward patients significantly reduced CPR events and rates, reduced hospital length of stay, and increased the number of RRT activations. There was no difference in the ICU admission rates. Further evaluation of the system in surgical wards and mixed settings [should be] conducted.”

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi^™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

References

1. Balshi AN, Al-Odat MA, Alharthy AM, Alshaya RA, Alenzi HM, Dambung AS, Mhawish H, Altamimi SM, Aletreby WT. Tele-Rapid Response Team (Tele-RRT): The effect of implementing patient safety network system on outcomes of medical patients—A before and after cohort study. PLoS ONE. 17(11):e0277992. DOI: 10.1371/journal.pone.0277992.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Patient SafetyNet™ and Replica^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Patient SafetyNet and Replica, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]

New Prospective Study Evaluates the Accuracy of Masimo SpHb^® Noninvasive and Continuous Hemoglobin Monitoring During Elective Cesarean Section

Masimo SpHb Demonstrated ?Clinically Acceptable Accuracy? of Hemoglobin Measurement, Even at Low Hemoglobin Levels

Neuchatel, Switzerland - January 3, 2023 - Masimo (NASDAQ: MASI) today announced the findings of a prospective study published in the Egyptian Journal of Anesthesia in which Dr. Mohamed Ibrahim Beleta and colleagues at Cairo University evaluated the accuracy of noninvasive, continuous hemoglobin monitoring with Masimo SpHb^® on patients undergoing elective cesarean section (CS) with antepartum hemorrhage. The researchers found significant positive correlations between SpHb and invasive hemoglobin (Hb) values, and concluded, "In patients undergoing CS with antepartum hemorrhage, continuous SpHb through Masimo Pulse CO-Oximetry demonstrated clinically acceptable accuracy of Hb measurement compared with invasive Hb, even at low hemoglobin levels."¹

The authors note that antepartum hemorrhage is associated with adverse maternal and neonatal outcomes and that blood transfusion is also associated with a variety of risks, but that invasive laboratory hemoglobin measurement, while a crucial factor in transfusion decisions, yields intermittent and often delayed results. The researchers thus sought to evaluate whether use of noninvasive, continuous hemoglobin monitoring might ?enable a more rapid detection of clinically significant blood loss, improve perioperative transfusion practices, allow patient condition to be assessed more quickly and blood management more adequately, and perhaps even reduce needless transfusions.? They enrolled 60 pregnant women, aged 18-45, scheduled for elective CS under general anesthesia between April 2016 and December 2017. All subjects had antepartum hemorrhage and were candidates for blood transfusion. During the procedure, all patients were monitored as per hospital standards, and in addition, with Masimo SpHb. All blood samples (Lab Hb) were analyzed using the same Coulter laboratory analyzer to avoid variance induced by the use of multiple devices. Lab Hb and SpHb values were recorded before induction of anesthesia (baseline), before transfusion, and after transfusion. Blood transfusion was carried out when Lab Hb decreased by more than 20% from baseline.

The researchers found significant positive correlations between SpHb and invasive Hb at the three points of comparison: baseline (r = 0.946), pre-transfusion (r = 0.902), and post-transfusion (r = 0.698). Differences at those times were insignificant: p = 0.196, p = 0.092, and p = 0.570, respectively. Using Bland-Altman analysis, they found low bias and moderate limits of agreement: 0.348 g/dL (-0.584 and 1.280) at baseline measurement, 0.314 g/dL (-0.561 and 1.188) at pre-transfusion, and 0.348 g/dL (-0.584 and 1.280) at post-transfusion.

The investigators concluded, "Continuous SpHb Masimo Pulse CO-Oximetry shows an appropriate clinically reliable Hb calculation in comparison to Invasive Hb even in patients undergoing CS with low hemoglobin. Further studies are needed on larger sample size with multicenter collaboration. Furthermore, we recommend the assessment of this technique on patients with common morbidities, such as high cholesterol, high blood pressure, and diabetes."

The researchers also noted that "SpHb evaluation has the potential for additional benefits, including patient comfort, increased safety, and decreased complexity for healthcare staff, who are not exposed to the risks of needle-stick injury and bloodspill contamination."

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

@Masimo || #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^®, Radius PPG^®, and Radius VSM™, portable devices like Rad-67^®, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica^®, Halo ION^®, UniView^®, UniView :60™, and Masimo SafetyNet^®. Its growing portfolio of health and wellness solutions includes Radius T°^® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Beleta MI, Abdallah SR, Hammad YM, Hossam EMY, Ali ABE, Mohamad AA, AbdElhameed BM. Noninvasive continuous hemoglobin monitoring of blood transfusion in obstetric procedures. Egyptian J Anesth. 2022, Vol. 38, No. 1, 701-708. https://doi.org/10.1080/11101849.2022.2153976.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET? can be found on our website at www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; Jan 8;338.
5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
6. Taenzer A et al. Postoperative Monitoring ? The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7.  McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
9. Estimate: Masimo data on file.
10. health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC’s website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We do not undertake any obligation to update, amend or clarify these statements or the “Risk Factors” contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: [email protected]