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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).

Masimo VCAM with Root®

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: elamb@masimo.com

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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 

Masimo Root®

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: elamb@masimo.com

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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™ and Philips Enterprise Patient Monitoring

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: elamb@masimo.com

Philips
Meredith Amoroso
Phone:(724) 584-8991
Email: meredith.amoroso@philips.com

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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: elamb@masimo.com

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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

Masimo Rad-67® with SpHb®

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: elamb@masimo.com

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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

Masimo Patient SafetyNet™ with Replica® and Root®

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: elamb@masimo.com

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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

Masimo Root® with SpHb® and PVi®

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: elamb@masimo.com

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