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 New Study Finds That Masimo PVi® May Be Useful in Helping ER Doctors Determine the Severity of Asthma Attacks in Pediatric Patients

Researchers Said Masimo PVi Can Be Used As a “Noninvasive, Rapid, and Objective Tool” for Helping Clinicians Predict Response to Treatment and Follow Up in Children with Obstructive Respiratory Disease

INeuchatel, Switzerland – May 23, 2022 - Masimo (NASDAQ: MASI) ) today announced the findings of a retrospective study published in the American Journal of Emergency Medicine in which Dr. Gülsah Demir and colleagues at Tepecik Research and Training Hospital in Izmir, Turkey investigated the potential ability of Masimo PVi® to guide emergency room triage decisions for pediatric patients with signs of obstructive respiratory disease, such as an asthma attack. PVi, or pleth variability index, is a noninvasive measurement of changes in perfusion index that occur during one or more respiratory cycles. The researchers concluded that “Automatic PVi measurement can be used as a noninvasive, rapid, and objective tool in the emergency department triage of patients admitted to the pediatric emergency department with signs of asthma attack or reactive respiratory tract disease.”1

Masimo Radical-7® with PVi®

Masimo Radical-7® with PVi®

Acute asthma attack is a common cause of admission to emergency departments (EDs) among children, and triage by severity is important for determining appropriate clinical treatment.2,3 Noting that PVi has been shown to be an accurate method for measuring the degree of pulsus paradoxus,4,5 a reduction in systolic blood pressure associated with obstructive respiratory tract disease, the authors sought to understand whether PVi might be of assistance to ED clinicians needing to make rapid triage decisions in such cases. They enrolled 133 patients between the ages of 2 and 18 (median age 5 years old) who arrived at the ED between May 2020 and July 2021 with a diagnosis of asthma attack or reactive respiratory tract disease. During initial examination and after treatment, patients’ PVi levels were measured using Masimo Radical-7® Pulse CO-Oximeters®. Severity of the asthma attack/respiratory disease was graded using the Pulmonary Index Score (PIS). Treatment decisions, including to hospitalize or to discharge, were made by clinicians who were blinded to PVi values.

The researchers found that PVi values, both before and after treatment, were significantly higher in patients with “severe” disease, compared to “mild” or “moderate” disease (p < 0.001): “Severe” patients had median PVi values of 47% (42 – 51) before treatment and 38% (32 – 44) after treatment; “moderate” patients, 31.5% (26 – 39) before and 25% (20 – 29) after; and “mild” patients, 24% (19 – 27) before and 19.5% (17 – 22) after. PVi values were also significantly higher for patients who were hospitalized, compared to those who were discharged from the ED (p < 0.001): Hospitalized patients had median PVi values of 46.5% (39 – 49) before treatment and 38% (29 -44) after treatment; discharged patients, 26% (22 – 34) before and 21% (18 – 26) after. For all severity levels, post-treatment PVi values were significantly lower than pre-treatment values (p < 0.001). The researchers calculated a pre-treatment PVi cut-off level of 37.5% for predicting whether a patient had “severe” disease (68.75% positive predictive power, with 100% sensitivity and 85% specificity, p < 0.001) and would require hospitalization (72.34% positive preditive power, with 91.89% sensitivity and 71.74% specificity, p < 0.001).

The authors concluded, “The severity of attacks of many patients who apply to the pediatric emergency department because of an attack due to obstructive respiratory tract diseases can be accurately defined with certain clinical evaluation tools. Although PIS is a very important tool for assessing attack severity, it includes some subjective parameters. Automatic PVI measurement can be useful in intensive emergency department conditions, especially in triage, in terms of predicting the response of patients to treatment and follow-up results by quickly determining the severity of attacks, and in terms of reducing subjective clinical decision variations among physicians. This is because it provides objective data.”

In the U.S., PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult 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. Our mission is to 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.6 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.9-12 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,13 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.14 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies, whose brand include Bowers & Wilkins®, Denon®, Polk Audio®, Marantz®, Definitive Technology®, Classé®, and Boston Acoustics®. Additional information about Masimo and its products may be found a   https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Demir G, Berksoy E, Bardak S, Elibol P, Çiçek A, Özon A, Nalbant T, Gölkap G. Use of the pleth variability index in children with obstructive respiratory disease. Amer J Emerg Med. 11 Mar 2022. DOI: https://doi.org/10.1016/j.ajem.2022.03.019
  2. Network, B.T.S.S.I.G. British guideline on the management of asthma [Internet]. 2016 [cited 2019 June26]. Available from: https://www.brit-thoracic.org.uk/qualityimprovement/guidelines/asthma/
  3. Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015;46(3):622‐39.doi: 10.1183/13993003.00853-2015.
  4. G Krishnan S, Wong HC, Ganapathy S, Ong GY. Oximetry-detected pulsus paradoxus predicts for severity in paediatric asthma. Arch Dis Child. 2020 Jun;105(6):533-38. doi: 10.1136/archdischild-2019-318043.
  5. Brandwein A, Patel K, Kline M, Silver P, Gangadharan S. Using pleth variability as a triage tool for children with obstructive airway disease in a pediatric emergency department. Pediatr Emerg Care. 2018;34(10):702-5. doi: 10.1097/PEC.0000000000000887.
  6. 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.
  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. 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.
  10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  11. 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.
  12. 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.
  13. Estimate: Masimo data on file.
  14. http://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 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
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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Masimo O3® Receives FDA Clearance for Absolute Regional Oxygen Saturation for Somatic Sites

Absolute Somatic Accuracy Enables Clinicians to Monitor Organ Tissue Oxygen Saturation with Greater Confidence Than Ever

Irvine, California – April 25, 2022 – Masimo (NASDAQ: MASI) today announced the FDA 510(k) clearance of the absolute accuracy of O3® regional oximetry for use in monitoring adult somatic tissue oxygen saturation. With this clearance, O3 is now indicated for use in monitoring both absolute and trending regional oxygen saturation (rSO2) in the U.S. in both cerebral and somatic applications for adults. Unlike somatic oximetry solutions that are indicated only for trending measurement, O3 with absolute rSO2 offers clinicians greater confidence that displayed values correlate with tissue oxygenation.

Masimo Patient SafetyNet<sup>™</sup>

Masimo O3® Regional Oximetry

O3 regional oximetry continuously monitors the oxygen saturation of hemoglobin in the tissue under the sensor – whether in the brain or another tissue – with absolute accuracy specifications of 5% ARMS* (adult somatic, pediatric cerebral) and 4% ARMS (adult cerebral) and a trending specification of 3% ARMS (cerebral and somatic, all ages) through the use of O3 multi-wavelength sensors and O3 near-infrared spectroscopy (NIRS) technology. Unlike peripheral pulse oximetry, which reflects the body's general arterial blood oxygenation, O3 provides information about the hemoglobin oxygen saturation in local tissue, whether cerebral or somatic tissue. The absolute accuracy specifications were validated by comparing O3 rSO2 values to arterial and venous saturation values obtained via blood draw. With the clearance for absolute accuracy of somatic rSO2, clinicians can now monitor not only the direction of changes in a specific tissue's level of oxygen saturation (whether rSO2 is rising or falling) but also an rSO2 value established through comparison to a blood reference – information that may provide additional insight into a patient’s local oxygenation during various surgeries.

Monitoring both brain and somatic tissue oxygenation simultaneously has been found to further improve clinicians' ability to provide rapid and accurate care.1 André Denault, MD, PhD, Department of Anesthesiology, Critical Care Program at the Montreal Heart Institute and Central Hospital of the University of Montreal, said, "There is a growing interest in the use of somatic NIRS owing to the association of cerebral and somatic desaturation with unfavorable outcomes in shock states. As an addition to O3 cerebral oximetry, the somatic component could serve as an earlier warning of impaired tissue perfusion. Somatic NIRS has been validated as a monitor of peripheral perfusion and shows an excellent correlation with peripheral perfusion compared with radionuclide plethysmography. As previously reported,2 cerebral and somatic NIRS combined with bedside whole-body ultrasound can help in early detection of different types of shock to formulate proper therapeutic strategies."

O3 seamlessly integrates with the Root® Patient Monitoring and Connectivity Platform, a powerful, expandable monitor that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root's plug-and-play expansion capabilities allow clinicians to simultaneously monitor with O3, SedLine, and other measurements, such as SET® Measure-through Motion and Low Perfusion™ pulse oximetry, providing clinicians with expanded visibility of oxygenation status. Additional modalities available on Root include advanced rainbow® noninvasive measurements such as total hemoglobin (SpHb®) and PVi® (an indicator of fluid responsiveness), NomoLine® capnography, and more – all via an easy-to-interpret, customizable display. Using Root in combination with the Masimo Hospital Automation™ platform, monitoring data from O3 can be automatically charted in electronic medical records (EMRs). The O3 module is also available through the integration into OEM partner monitors.

Joe Kiani, Founder and CEO of Masimo, said, "Keeping an eye on the precise oxygenation status of individual organs can be critical in the operating room. This additional indication for O3 further expands its utility, giving clinicians more confidence that displayed somatic rSO2 values have been established in comparison to a blood reference. Now more than ever, we believe that O3 represents an important resource for helping clinicians and researchers better understand how the body utilizes oxygen."

 

@Masimo || #Masimo

*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study.

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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.11 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Lecluyse et al Desaturation in the Intensive Care Unit: Preliminary Experience and Review. J Cardiothoracic Vascular Anesth. (2017) 1805-1809.
  2. Denault A et al. A Practical Approach to Cerebro-Somatic Near-Infrared Spectroscopy and Whole-Body Ultrasound. J Cardio Vasc Anesth. 2019;03.039. DOI: https://doi.org/10.1053/j.jvca.2019.03.039
  3. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. http://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 O3®. 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 O3, 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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Medical Monitoring Pioneer Announces the Limited Market Release of the Masimo W1™ Watch for Consumers

On Its Anniversary, The Inventor of Measure-through Motion and Low Perfusion™ Pulse Oximetry Introduces the First Health Watch to Offer Accurate, Continuous Measurements

Irvine, California – April 25, 2022 – Masimo marks its 33rd anniversary today by announcing the limited market release of the W1™ health watch for consumers. The first of its kind, the Masimo W1 offers accurate, continuous measurements and actionable health insights – from the leader in hospital pulse oximetry – in a personal, discreet, lifestyle-friendly wrist-worn wearable. Building on Masimo's decades of leadership in creating revolutionary noninvasive blood parameter monitoring solutions, W1 provides accurate, continuous monitoring of multiple health parameters – including oxygen saturation (SpO2), pulse rate, perfusion index, PVi®, and respiration rate, alongside step count and fall detection.

Masimo Patient SafetyNet<sup>™</sup>

Masimo W1™

Incorporated on May 2, 1989 as a garage startup dedicated to solving the "unsolvable" problem of inaccurate and unreliable conventional pulse oximetry under real-life conditions such as patient movement, Masimo and its breakthrough Measure-through Motion and Low Perfusion™ SET® pulse oximetry today touch hundreds of millions of lives around the world each year.1 SET® pulse oximetry has been shown in more than 100 independent studies to outperform other pulse oximetry technologies,2 and is the only pulse oximetry shown in numerous large studies – involving more than 300,000 infants – to improve critical congenital heart disease (CCHD) screening in newborns.3-13 SET® pulse oximetry has also been shown to improve outcomes for patients on opioids in post-surgical wards,14-17 reduce eye damage and blindness in the neonatal intensive care unit,18 and reduce mortality among COVID patients remotely monitored at home.19 Through Masimo's continued focus on innovation and improvement, SET® has evolved to feature the industry's highest accuracy specifications, on the new RD line of patient sensors; become tetherless, with the secure Bluetooth®-equipped continuous Radius PPG™; and now, as the foundational technology driving the W1, has become a truly lifestyle-friendly technology for consumers outside hospitals.

For the limited market release of W1, Masimo is inviting a select group of early adopters to help evaluate and refine the product over the coming months. Masimo will provide up to 10,000 W1s on a first-come, first-served basis, at a 50% discount, to users who agree to the program details and to provide feedback and data to Masimo. For additional information and to express interest in the program, please go to www.masimo.com/w1.

With this consumer release of W1, Masimo is bringing its expertise in medical monitoring, connectivity, and automation to consumers looking to take control of their personal health, including those wanting to fine-tune their athletic training and recovery, the quality of their sleep, and their overall physiological status. Paired via secure Bluetooth to the Masimo Personal Health smartphone app, W1 provides continuous health data and guidance with accuracy heretofore unknown in a wrist-based device, unlocking meaningful, actionable insights – all in the convenient and discreet form of a durable watch.

Tommy Haas, former professional tennis player, commented, "I've always believed in the power of data to improve my performance. Accurate vital sign measurements have helped me track my activity and recovery both on and off the court. Now with Masimo W1, I have a convenient way to continuously track my vitals right on my wrist."

In addition to use by consumers, W1 is also available outside the U.S. for telehealth applications, benefiting from Masimo's expertise not only in noninvasive monitoring but in hospital connectivity and automation innovations. For patients recovering at home after surgery or illness, as well as patients with chronic conditions (such as heart failure, COPD, or cancer), W1 represents a convenient, reliable remote patient monitoring and telehealth solution enabling clinicians to keep track of their patients' physiological status from afar, even as patients go about everyday tasks at home. A natural complement to the Masimo SafetyNet® remote patient monitoring platform, W1 enables wireless transmission of patient data to the Masimo SafetyNet smartphone app and Masimo’s secure data cloud.

Dr. Abeer Bakhsh, Head of the Heart Function Unit at Prince Sultan Cardiac Center in Saudi Arabia, which has been using W1 for telehealth monitoring of patients, commented, "We have begun using Masimo W1 with Masimo SafetyNet for remote patient monitoring of our chronic heart failure patients. The watch is very comfortable to wear, and the continuous Masimo measurements give us confidence to help keep our patients safe."

Joe Kiani, Founder and CEO of Masimo, said, "As we celebrate our 33rd year, and as we embark on the next chapter of our expansion through the recent acquisition of Bowers & Wilkins, Denon, Marantz, Polk Audio and their home automation technologies, it is only fitting that we are today debuting the first wearable device to offer accurate and continuous physiological measurements based on the technology we’ve honed for use in hospitals for more than three decades. From our own original breakthrough technology, SET® pulse oximetry, to our advanced hospital monitors like Root®, to our Hospital Automation™ platform and its many innovative connectivity and remote monitoring systems, to our tetherless Masimo SafetyNet remote and home patient management and telehealth solutions, and now to W1, we are excited to be able to bring our technologies directly to even more people everywhere."

The Masimo W1 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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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,18 improve CCHD screening in newborns,4-13 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,1 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.20 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. 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.
  3. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. Zhao et al. Lancet. 2014;384(9945):747-54.
  5. Gunaratne CR et al. Sri Lanka J Child Health. 2021;50(1):04-11.
  6. Slitine N et al. Int J Neonatal Screen. 2020;6(53).
  7. Ewer AK et al. Lancet. 2011;378(9793):785-94.
  8. de-Wahl Granelli A et al. Acta Paediatr. 2007;96(10):1455-9.
  9. Meberg A et al. J Pediatr. 2008;152:761-5.
  10. Schena F et al. J Pediatr. 2017;183:74-79.
  11. Hamilçıkan S, Can E. J Perinat Med. 2018;46(2):203-207.
  12. Jawin V et al. PLoS One. 2015;10(9):e0137580.
  13. Gopalakrishnan S et al. Med J Armed Forces India. 2021;77(2):214-219.
  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. 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.
  19. Pronovost P, Cole M, Hughes, R. Remote Patient Monitoring During COVID-19: An Unexpected Patient Safety Benefit. JAMA. Published online February 25, 2022. doi:10.1001/jama.2022.2040.
  20. http://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™. 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 W1, contribute to positive clinical outcomes and patient safety; risks that Masimo W1 fails to be available 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.

Media Contact
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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Masimo SedLine® Brain Function Monitoring Reduced the Use of Anesthetic Agents and Opioids in a Study on Patients Undergoing Cardiac Surgery

SedLine Was Also Associated with Reduction in Bleeding During Surgery and Shorter Duration on Mechanical Ventilation

Irvine, California – April 25, 2022 – Masimo (NASDAQ: MASI) today announced the findings of a retrospective study published in the Journal of Cardiothoracic and Vascular Anesthesia in which Dr. André Denault and colleagues at the Montreal Heart Institute and Centre Hospitalier de l’Université de Montréal investigated the impact of anesthesia during cardiac surgery guided by Masimo SedLine® Brain Function Monitoring, in particular by SedLine’s processed electroencephalography (pEEG) feature, the Patient State Index (PSi). This study is the first to primarily explore the impact of pEEG-guided anesthesia on vasoactive and inotropic drugs—drugs that affect the diameter of blood vessels and that modify the force of the heart’s contractions, respectively—in the ICU. The researchers found that pEEG-guided anesthesia was associated with a reduction in the use of such drugs, as well as less use of anesthetic agents and opioids in the OR, lower central venous pressure (CVP), less fluid administration, less intraoperative bleeding, and shorter duration on mechanical ventilation.1

Masimo Patient SafetyNet<sup>™</sup>

Masimo Root® with SedLine® Brain Function Monitoring

Noting that pEEG-guided anesthesia may improve hemodynamic stability and that high postoperative doses of vasoactive and inotropic drugs have been associated with mortality and renal dysfunction, the researchers sought to determine whether use of pEEG-guided anesthesia might improve outcomes by reducing use of such agents during cardiac surgery and at arrival in the ICU. Their primary goal was to determine whether pEEG-guided anesthesia would be associated with reduced hemodynamic instability during cardiopulmonary bypass (CPB) separation, measured by stratifying the operation into three categories: “easy” (use of only one vasoactive or one inotropic agent), “difficult” (use of at least two different classes of agents), or “complex” (requiring a return to CPB or use of mechanical circulatory support). Their secondary goal was to determine if pEEG-guided anesthesia would lead to the hypothesized reduction in vasoactive and inotropic drug administration in the ICU, measured by vasoactive and inotropic score (VIS). 

The researchers compiled a retrospective cohort of 300 adult patients who underwent cardiac surgery using CPB between 2013 and 2020 at the Montreal Heart Institute. The patients were divided into two groups, depending on whether anesthesia was guided by pEEG, which became a standard of care in 2017. Patients in the pEEG group (n=150) had their brain function monitored, from the moment they entered the OR to arrival in the ICU, using Masimo SedLine.

In the pEEG group, patients received fewer vasoactive and inotropic drugs in the first hour after ICU admission, resulting in lower VIS scores (pEEG: 5 [0-10], control: 8 [2-15], p=0.003). Being in the pEEG group reduced the odds of being in a higher VIS category by 57% (OR=0.43; 95% confidence interval: 0.26-0.73; p=0.002). In addition, in the pEEG group, several additional outcomes were lower: duration of mechanical ventilation (pEEG: 3 hours [2-4 hours], control: 4 hours [3-7 hours], p<0.001), intraoperative fluid balance (pEEG: 758 mL [351-1329 mL], control: 500 mL [300-700 mL], p=0.002), and the amount of bleeding (pEEG: 400 mL [282-500 mL], control: 500 mL [300-700 mL], p=0.002).

A lower proportion of patients experienced unsuccessful (difficult or complex) CPB separation in the pEEG group than the control group (60% vs. 72%, p=0.028). However, after adjusting for other parameters using multiple logistic regression, use of pEEG-guided anesthesia was not independently associated with successful CPB separation; instead, as the researchers note, unsuccessful separation was associated with several independent known predictors of hemodynamic complications.

The researchers concluded, “pEEG-guided anesthesia is associated with a reduction in the use of inotropic or vasoactive drugs at arrival in the ICU. In addition, its implementation was associated with lower requirements of anesthetic agents and opioids in the OR, lower CVP, fluid requirements, intraoperative bleeding, and shorter duration of mechanical ventilation. However, its use did not facilitate weaning from CPB compared to a group where pEEG was unavailable. Future research is needed to confirm these results in prospective randomized clinical trials.”

@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. Our mission is to 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.10 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies.   Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Jarry S, Halley I, Calderone A, Momei M, Deschamps A, Richebé P, Beaubien-Souligny W, Denault A, Couture E. Impact of Processed Electroencephalography in Cardiac Surgery: A Retrospective Analysis. J Cardio Vasc Anesth. March 2022. DOI: 10.1053/j.jvca.2022.03.030
  2. 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.
  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. https://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®. 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 SedLine, 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
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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New JAMA Article Highlights the Outcome and Safety Benefits of Remote Patient Monitoring During the Pandemic and Beyond

Masimo SafetyNet® Reduced Mortality Among COVID-19 Patients

Irvine, California – April 12, 2022 – Masimo (NASDAQ: MASI) today announced the findings of a Viewpoint article recently published in the Journal of the American Medical Association (JAMA) which highlighted the benefits of remote home patient monitoring, reporting in part on research that used Masimo SafetyNet®, a remote patient management solution. In the article, "Remote Patient Monitoring During COVID-19: An Unexpected Patient Safety Benefit," Peter J. Pronovost, MD, PhD, and colleagues Melissa Cole, MSN, and Robert Hughes, DO, at University Hospitals Health System (UH) and Case Western Reserve University in Cleveland, Ohio conclude that through recent technological advances in remote monitoring, a patient's physiological needs can now more often be the primary factor in determining the level of monitoring they receive, rather than their physicallocation (i.e. the monitoring capabilities of the beds in a particular hospital care area).1 By not only ensuring that patients receive the appropriate level of monitoring, but enabling lower-acuity patients to be safely and reliably monitored in the comfort of their own home, Masimo SafetyNet remote patient monitoring solutions helped keep valuable hospital beds free for higher-acuity patients and improve patient safety while doing so.

Masimo Radical-7<sup>&reg;</sup> with SpHb<sup>&reg;</sup>

Masimo SafetyNet®

To frame their argument, the authors note that the COVID-19 pandemic has "accelerated the move to monitoring and therapy based on patient risks and needs" through a "combination of medical urgency, technology advances, and payment policy." In their article, they stress the importance of continuous monitoring throughout the patient’s hospital stay, and while still ill in the home. The authors also highlight the newly recognized benefits of this shift to monitoring based on need (not location) by demonstrating how technological advances have led to impressive positive outcomes for patients monitored at home. They note that the same "[Masimo SET®] Pulse oximeters used in hospitals can now be deployed at home with patient data relayed to smartphones, secure cloud servers, and web-based dashboards where physicians and hospitals can monitor the patient’s status in near real time." This capability not only improves patient satisfaction, but leads to better patients outcomes and can "help avoid hospitalizations."

The authors note that "A recent cost-utility analysis estimated that daily assessment and 3-week follow-up of at-home pulse oximetry monitoring was projected to be potentially associated with a mortality rate of 6 per 1000 patients with COVID-19, compared with 26 per 1000 without at-home monitoring. Based on a hypothetical cohort of 3,100 patients, the study projected that remote monitoring could potentially be associated with 87% fewer hospitalizations, 77% fewer deaths, reduced per-patient costs of $11,472 over standard care, and gains of 0.013 quality-adjusted life-years."2 Masimo SafetyNet with SET® pulse oximetry and Radius PPG™ was used in the study. In another study of 33 severe COVID-19 patients discharged home, telemonitoring was found not only to be "safe, user friendly, cost-effective," but to reduce hospitalization by a mean of 6.5 days for patients requiring home oxygen.3

The researchers outline a series of steps they believe public health agencies and health systems should take to effectively encourage and implement remote patient monitoring. In conclusion, they note, "Home monitoring and hospital at-home models offer the potential to transform care and potentially allow a substantial proportion of hospitalized patients to receive care from home. Yet health systems will need to collaborate with technology companies to accelerate learning and produce greater value for patients, clinicians, and health care organizations."

Dr. Peter Pronovost, Chief Quality and Clinical Transformation Officer at UH and Clinical Professor of Anesthesiology and Perioperative Medicine at Case Western Reserve School of Medicine, said, "We could not have dreamed of remote monitoring if we didn't have the reliability of Masimo SET® pulse oximetry to provide us with accurate measurements of arterial blood oxygen saturation and pulse rate. Prior to the advent of Masimo SET® pulse oximetry, pulse oximeters were fraught with inaccurate measurements and false alarms, especially on active patients. With reliable pulse oximetry and telemonitoring, patients can now be monitored based on risks and needs rather than location in the hospital."

"Home monitoring and hospital at-home models offer the potential to transform care and potentially allow a substantial proportion of hospitalized patients to safely receive care from home," continued Dr. Pronovost.

Joe Kiani, Founder and CEO of Masimo, said, "We are proud to collaborate with health systems around the world to share the benefits of Masimo SafetyNet and our other monitoring solutions with as many patients and communities as possible. We worked with Dr. Peter Pronovost and his colleagues closely to release Masimo SafetyNet early in the pandemic, in an effort to help clinicians combat COVID-19 through remote monitoring of quarantining and recovering patients safely and reliably at home, at a time when hospitals were experiencing dramatic surges in patient volume. We have been heartened to find that the combination of clinically proven Masimo SET® pulse oximetry, tetherless Radius PPG, advanced connectivity, our secure cloud offering, and streamlined automation has helped clinicians improve outcomes and save lives."

University Hospitals and Masimo will be conducting a joint webinar to discuss the JAMA article and the benefits of remote patient monitoring on May 12 at 12:00 pm ET.

@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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.12 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Pronovost P, Cole M, Hughes, R. Remote Patient Monitoring During COVID-19: An Unexpected Patient Safety Benefit. JAMA. Published online February 25, 2022. doi:10.1001/jama.2022.2040.
  2. Padula WV, Miano MA, Kelley MA, et al. A cost-utility analysis of remote pulse-oximetry monitoring of patients with COVID-2019. Value in Health. Published online October 22, 2021. doi:10.1016/j.val.2021.09.008 2014. 5:9. 2.
  3. Grutters LA, Majoor KI, Mattern ESK, Hardeman JA, van Swol CFP, Vorselaars ADM. Home telemonitoring makes early hospital discharge of COVID-19 patients possible. J AmMed Inform Assoc. 2020;27(11):1825-1827. doi:10.1093/jamia/ocaa168.
  4. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. http://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 SafetyNet® and the JAMA article based on research using Masimo SafetyNet ("the Article"). 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 SafetyNet, contribute to positive clinical outcomes and patient safety; risks that the researchers' conclusions and findings may be inaccurate; risks that Masimo fails to conduct a joint webinar to discuss the Article on May 12, 2022; 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 Contacts: 

Masimo
Evan Lamb
(949) 396-3376
elamb@masimo.com

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Masimo Closes Acquisition of Sound United

Leading Developer of Premium Consumer Sound and Home Integration Technologies Becomes Masimo Subsidiary

Irvine, California – April 12, 2022 – Masimo (NASDAQ: MASI) today announced that it has successfully completed the previously announced acquisition of Sound United, a leading consumer technology company and owner of multiple premium audio and home entertainment brands. Sound United will operate as a division of Masimo, under its existing leadership, from its headquarters in Carlsbad, California. Sound United operates iconic consumer brands including Bowers & Wilkins®, Denon®, Polk Audio®, Marantz®, Definitive Technology®, Classé®, and Boston Acoustics®. Sold worldwide, these brands are linked by a commitment to the highest production standards and a focus on unparalleled quality and performance.

Joe Kiani, Founder and CEO of Masimo, said, “We are thrilled to add Sound United’s premium technology, established consumer channels, and well-known brands to Masimo’s broad portfolio of hospital and home medical technology solutions. We believe Masimo’s expertise in advanced signal processing, biosensing, and photonics technologies combined with Sound United’s audio and home automation technologies will bring about natural and yet non-intuitive solutions to people around the globe in home and in hospitals. Masimo will leverage Sound United’s expertise across consumer channels to accelerate distribution of the combined company’s expanding portfolio of consumer-facing healthcare products. We welcome the incredibly talented and dedicated teams at Bowers & Wilkins, Denon, Marantz, Polk Audio, HEOS, Definitive Technology, Classé, and Boston Acoustics to Masimo.”

“While we continue to identify growth opportunities by leveraging the strengths and resources from both companies, we want to express our continued commitment to our loyal customers who rely on the Sound United brands to continue driving their businesses with best-in-class solutions and forward-thinking innovation,” said Kevin Duffy, CEO of Sound United. “With our track record of industry-first innovation, superior manufacturing, and a global distribution network, we are confident that Sound United is the ideal partner for Masimo as they transform and enrich the consumer healthcare experience.”

Financial guidance associated with the Sound United acquisition will be provided during Masimo’s first quarter earnings release on Tuesday, May 3, 2022.

@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. Our mission is to 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.9 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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 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.

About Sound United

Sound United, a Masimo company, was founded in 2012 with a simple mission – to bring joy to the world through sound. Today, we are one of the world’s largest portfolio audio companies and home to several legendary audio brands—Denon®, Marantz®, Bowers and Wilkins, Polk Audio, Classé, Definitive Technology, HEOS, and Boston Acoustics®. Each brand boasts its own philosophy and unique approach to bringing home entertainment to life. With centuries of collective experience, Sound United oversees the design and manufacture of a diverse array of premium audio products, including loudspeakers, sound bars, AV receivers, wireless speakers, amplifiers, turntables, and headphones. We create distinct and memorable listening experiences for a wide range of consumers in more than 130 countries. For more information on Sound United and our mission, please visit www.soundunited.com.

To learn more about Sound United and its brands, visit www.soundunited.com.

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 acquisition of Sound United; 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 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 Contacts: 

Masimo
Evan Lamb
(949) 396-3376
elamb@masimo.com

Sound United
Matt Whewell
Matt.whewell@soundunited.com

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New Study Finds That Noninvasive and Continuous Hemoglobin Improved Transfusion Management and Outcomes in Pediatric Patients

Children Monitored with Masimo SpHb® Had Less Blood Transfusion, Less Bleeding, and Shorter ICU Stays

Neuchatel, Switzerland – March 28, 2022 – Masimo (NASDAQ: MASI) today announced the findings of a retrospective study published in the Journal of Clinical Monitoring and Computing in which Dr. Ayten Saracoglu and colleagues at Marmara University in Istanbul, Turkey evaluated the impact of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® on perioperative transfusion management and postoperative patient outcomes on pediatric patients undergoing fronto-orbital advancement surgery. The researchers found that pediatric patients monitored with SpHb had lower intraoperative packed red blood cell (PRBC) transfusion, less postoperative bleeding, and shorter ICU stays.1

Masimo Radical-7<sup>&reg;</sup> with SpHb<sup>&reg;</sup>

Masimo Radical-7® with SpHb®

Noting the frequency of significant hemorrhage during craniofacial reconstruction surgery, and the importance of an adequate patient blood management (PBM) policy during such surgery, the researchers sought to determine whether PBM that included noninvasive and continuous hemoglobin monitoring might improve transfusion management and outcomes for children undergoing frontal advancement surgery. For their retrospective, case-control study, they collected data for 42 pediatric patients (average age 8.6 months ± 3.9 months) with plagiocephaly or trigonocephaly who underwent surgery between 2018 and 2021, dividing them into a group of 16 patients whose perioperative PBM included noninvasive, continuous hemoglobin monitoring (SpHb group), and 26 patients who were managed conventionally (control group). The SpHb group’s hemoglobin was intraoperatively monitored using SpHb on Masimo Radical-7® Pulse CO-Oximeters®.

The researchers found that patients in the SpHb group had significantly lower intraoperative PRBC transfusion (136.3 mL ± 40.1 mL vs. 181.5 mL ± 74.8 mL, p = 0.015), less postoperative surgical site drainage (125.3 mL ± 47.7 mL vs. 185.8 mL ± 97.6 mL, p = 0.013), and shorter postoperative ICU stay (37.1 hours ± 12.0 hours vs. 64.8 hours ± 24.9 hours, p < 0.001) than patients in the control group.

The investigators concluded, “SpHb measurement in pediatric craniofacial surgery for craniosynostosis is a safe, noninvasive tool to monitor Hb values and help transfusion decision-making, when used keeping in mind bias and inaccuracies of the device. Patients with continuous SpHb monitoring had decreased intraoperative PRBC transfusions, reduced postoperative surgical site bleeding, and shorter postoperative ICU stay.”

This study adds outcomes evidence for pediatric patients to the growing literature on the value of continuous hemoglobin monitoring with SpHb. In adults, SpHb, as part of PBM programs, has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving transfusions,2 reducing the units of red blood cells transfused per patient,3-5 reducing the time to transfusion,6 reducing costs,7 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®).8 This evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.1-8 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.

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. Our mission is to 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.9 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,10 improve CCHD screening in newborns,11 and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.12-15 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,16 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.17 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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®.  Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. 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.
  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. 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.
  4. Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.
  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. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  14. 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.
  15. 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.
  16. Estimate: Masimo data on file.
  17. https://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 SpHb, 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
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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Masimo Debuts Telehealth for Patient SafetyNet at HIMSS 2022 Global Health Conference

Remote Patient Monitoring Platform Enhanced with Secure, End-to-End, Multi-Way Audio and Visual Communication

Orlando, Florida – March 14, 2022 – Today at the 2022 HIMSS Global Health Conference, Masimo (NASDAQ: MASI) announced a major expansion of Masimo Patient SafetyNet, its premier hospital remote patient monitoring and clinician notification platform, with the addition of secure telehealth capabilities – making an already powerful solution even more versatile and comprehensive.

Masimo Patient SafetyNet™

Masimo Patient SafetyNet

Available via software upgrade for existing Patient SafetyNet systems, and seamlessly integrated into view stations, telehealth for Patient SafetyNet offers secure, end-to-end, multi-way audio and visual communication between the point of care (in the room or at the bedside) to central command rooms and remote clinicians – helping to improve clinical workflows and communication efficiency across the continuum of care – without interfering with the remote monitoring of patient data. As with the recently announced expansion of the Masimo SafetyNet® platform, the system integrates TODA transcoding technology from LMLabs, which dynamically adjusts bit rates based on available bandwidth to transcode live audio and video and ensure the highest quality reproduction while requiring dramatically less bandwidth. These capabilities can be hosted within existing hospital infrastructure or even reside in the cloud, helping hospitals manage resources and comply with IT requirements while supporting fast deployment and flexible scaling. 

Telehealth for Patient SafetyNet offers a host of additional advanced features designed to further improve workflow efficiency and accommodate as many communication and patient scenarios as possible. The platform supports multiple simultaneous audio and visual streams, allowing numerous clinicians and specialists to communicate and collaborate in real time, regardless of location. In addition to video discussions, users can also securely chat via text, transfer files, share their screens, and use collaborative digital whiteboards, providing seamless access to patient data, notes, and discussion in whatever medium is most relevant to each case.

With its added telehealth capabilities, Patient SafetyNet enables clinicians to remotely access continuous patient monitoring data, in near real time, while simultaneously communicating via live video stream with nurses and other clinicians – helping facilitate true 24/7 management of patient events from a central location. In addition, family members and other visitors can consult with remote clinicians virtually while staying by the patient’s bedside. Specialists and intensivists can take advantage of the streamlined multi-way communication and other advanced capabilities to offer their expertise on more patient cases, more easily than ever.

Joe Kiani, Founder and CEO of Masimo, said, “We are excited to be able to introduce such meaningful enhancements to Patient SafetyNet and showcase them at HIMSS, an organization and conference dedicated to enhancing how information is managed and conveyed in healthcare spaces. Just as telehealth for Masimo SafetyNet makes it possible for clinicians and patients to meet from afar, telehealth for Patient SafetyNet allows clinicians to collaborate and communicate in sophisticated but intuitive and efficient ways, ultimately helping to improve patient outcomes and reduce the cost of 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. Our mission is to 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.9 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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  https://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

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. 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 Patient SafetyNet, 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
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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Masimo Announces FDA Clearance of Pediatric Indication for SedLine® Brain Function Monitoring and the SedLine Pediatric EEG Sensor

SedLine's Advanced Depth of Anesthesia Monitoring Now Cleared for Use on Patients as Young as 1 Year Old in the United States

Irvine, California – February 28, 2022 - Masimo (NASDAQ: MASI)announced today the FDA clearance of SedLine® brain function monitoring for pediatric patients (1-17 years of age) and the SedLine Pediatric EEG Sensor. With this clearance, the potential benefits of SedLine have been expanded to all patients one year old and above in the United States. Equipped with Masimo's advanced signal processing technology, SedLine helps clinicians monitor brain activity bilaterally by processing electroencephalogram (EEG) signals from Masimo's four-lead SedLine EEG sensors.

Split image of patient talking to doctor on patients phone and doctor talking to patient on the doctors computer

Masimo SedLine® Brain Function Monitoring

This clearance brings Masimo's bilateral brain activity monitoring to children 1 to 17 years old, in conjunction with specially sized pediatric sensors designed for easier application on smaller pediatric foreheads. Brain activity monitoring under anesthesia on pediatric patients is different from that of adults.1-2 Maintaining an appropriate depth of anesthesia is key to preventing anesthesia-related events and enabling faster recovery.3 To aid clinicians in monitoring anesthesia depth on children, SedLine features both the display of EEG signals and the Multitaper Density Spectral Array (DSA) from both sides of the brain, to provide clinicians with a more complete picture of the brain.

Dr. Cristina Verdú of Hospital Universitario La Paz, Madrid, Spain, said, "SedLine is an easy window into a child's electroencephalogram. It helps us to personalize sedoanalgesia. Now, we can choose the appropriate dose according to its effects, not just according to weight or age. But in addition to monitoring anesthetic depth, it allows us to detect warning signs such as asymmetries or seizures; it tells us what is happening to the child's brain."

Joe Kiani, Founder and CEO of Masimo, said, "SedLine is achieving for brain function monitoring what Masimo SET® did for pulse oximetry. We believe SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging and the youngest brains are appropriately anesthetized. We are proud to be able to bring its benefits to children 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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.12 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Davidson et. Current Anesthesiology Reports 3. 1 (2013): 57-63.).
  2. Cornelissen L et al. Elife 4 (2015): e06513.
  3. Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260.
  4. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. http://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 the SedLine Pediatric EEG Sensor, as well as their FDA clearance for pediatric patients. 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 SedLine, 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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Masimo Adds Telehealth to Its SafetyNet® Telemonitoring System

Patient Management Platform Combines Clinically Proven Continuous Remote Monitoring, Full-Featured Video-Based Virtual Consultations, EMR Connectivity, and More

Irvine, California – February 10, 2022 - Masimo (NASDAQ: MASI) today announced a major expansion of Masimo SafetyNet® that brings robust, secure video conferencing to the remote patient management and connectivity platform to offer a comprehensive telehealth and telemonitoring solution—and for patients, a better “hospital at home” experience. Now, Masimo SafetyNet allows clinicians and hospitals to schedule and conduct multi-way audio- and video-based virtual appointments with at-home patients through the Masimo SafetyNet smartphone app—while still viewing continuous and spot-check vital signs and other physiological data. By combining the power of advanced remote patient monitoring, including Masimo’s clinically proven SET® pulse oximetry technology, with telemedicine capabilities like virtual visits and the benefits of Masimo’s Hospital Automation platform, such as full two-way integration with hospital electronic medical records (EMRs), Masimo SafetyNet enables use of telehealth: the ability to provide full-featured remote care with virtual face-to-face meetings while simultaneously accessing a patient’s continuous physiological data.

Split image of patient talking to doctor on patients phone and doctor talking to patient on the doctors computer

Masimo SafetyNet®

Masimo has integrated TODA, a robust audio and video transcoding technology from LMLabs, to expand Masimo SafetyNet beyond its original remote patient management capabilities. The integrated video solution dynamically adjusts bit rates based on the available bandwidth to transcode live, secure audio and video and ensure the highest quality reproduction with dramatically less required bandwidth. For clinicians, this means they get the best quality virtual visit combined with real-time patient data, no matter where the patient is. Not only are clinicians able to communicate with their patients, but also collaborate with them with the ability to share their screen, launch a digital whiteboard, chat via in-app secure messaging, or invite additional clinicians for more expertise.

For patients, Masimo SafetyNet is now the easiest way to connect with their doctors and care team without having to download additional apps or send in their physiological measurements separately. Their virtual visits are conducted through the same smartphone app that collects their oxygen saturation, pulse rate, respiration rate, temperature, and other data from tetherless Masimo Radius PPG and Radius Tº sensors. Through the new virtual whiteboard, providers can educate and share additional information as part of the discussion, enriching patient-clinician interactions and allowing them to be tailored to meet each patient’s health and communication needs. The integrated messaging feature offers yet another way for patients to stay in touch with their care teams, when a full video consultation is not needed.

Joe Kiani, Founder and CEO of Masimo, said, “Masimo SafetyNet has been helping clinicians save and improve patients’ lives at home and in the hospital, around the world, since the start of the pandemic. With the addition of advanced telehealth capabilities, our already powerful remote monitoring solution becomes an even more comprehensive platform.”

Designed to help providers remotely manage patient care, Masimo SafetyNet is a secure, scalable, cloud-based patient management platform that features clinical-grade spot-checking and continuous measurements, CarePrograms (customizable digital care plans), remote patient surveillance, and flexible, automated, two-way integration with hospital EMR systems – now augmented with video telemedicine. First developed for use during the COVID pandemic, for lower-acuity patients recovering or quarantining at home, Masimo SafetyNet has expanded use to post-surgical patients, patients with a variety of chronic conditions, and to patients with episodic illnesses, including fever. The platform helps seamlessly extend care from the hospital to the home (or any other location outside of the hospital or doctor’s office) by collecting monitoring data from the fingertip and chest-worn sensors, relayed to the patient’s smartphone with Bluetooth®, and from there to the secure Masimo SafetyNet cloud. Using the web-based clinician portal, doctors and other clinicians can keep an eye on patients’ physiological progress from afar, intervening if a patient’s condition appears to worsen, and now with the ability to conduct comprehensive virtual visits as well.

@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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.9 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG, 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 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. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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 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

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 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 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 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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Temple University Hospital Adopts Masimo Centroid™

Premier Philadelphia Academic Medical Center Implements Advanced Masimo Wearable, Wireless Patient Position, Orientation, and Activity Sensors in its ICUs

Philadelphia, Pennsylvania - February 7, 2022 - Masimo (NASDAQ: MASI) and Temple Health today announced that Temple University Hospital (TUH), a 722-bed academic medical center located in Philadelphia, is expanding its use of Masimo technologies with Centroid™, an advanced wireless patient position, orientation, activity, and respiration rate sensor, at 100 beds across its ICU units.

Masimo Root® with O3® Regional Oximetry and SedLine® Brain Function Monitoring

Masimo Centroid™ with Root® and Replica®

Centroid helps clinicians monitor patient position to avoid preventable pressure injuries, 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 that may inform care decisions. Centroid pairs with the Root® Patient Monitoring and Connectivity Platform 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.

At TUH, all ICU beds are being equipped with Root and with Centroid, including the Trauma ICU, Cardiothoracic ICU, Burn ICU, Neurological ICU, and Medical Respiratory ICU. Angelo Venditti, DNP, RN, Executive Vice President for Patient Care and Chief Nursing Executive at Temple Health, said, "We are pleased to expand our relationship with Masimo, which has already proven itself as a key technology partner in our efforts to improve patient outcomes. When we trialed Centroid, we found it helped our teams prioritize workflows more effectively, with increased focus on following turn protocols and decreased incidence of pressure injuries."

Hospital-acquired pressure injuries (HAPI), commonly known as bed sores, are on the rise – occurring in nearly 5% of all hospitalized patients in the US.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," or 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. 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 hospitals in the US still use techniques such as paper wall clocks or egg timers to try and optimize this practice4 – methods that are proving to be ineffective and archaic in modern healthcare. Staffing issues and competing priorities have strained nurses across the US, and staying on top of when a patient was last turned is difficult without a more sophisticated system.

Centroid is a single-patient-use adhesive sensor indicated for the orientation monitoring of patients who may be susceptible to pressure ulcers by tracking patient movement and activity using an accelerometer and gyroscope. Centroid can identify a patient's position and orientation to the nearest degree, with alerts based on the duration in a static position to help clinicians adhere to hospital patient turn protocols. Centroid also features customizable alarm zones to help avoid patient positions that could negatively impact recovery time. Unlike simple time-based rotation protocols, Centroid provides an advanced pressure risk algorithm that takes into account the cumulative pressure exposure time, with body segment-by-segment resolution, using the integrated gyroscope, displayed on the Root screen using color-coded markers. This can help clinicians not only identify if a patient has been turned, but also identify if the new position may still be resulting in pressure risk to the same tissue – and ultimately, helping to guide clinical decisions about the most appropriate, least risky positions for each patient.

Temple Health and Masimo have been pulse oximetry technology partners since 2008. Temple implemented Masimo Patient SafetyNet in 2014, has since expanded their Patient SafetyNet system to seven units, and has also adopted Masimo SpHb® noninvasive hemoglobin monitoring, NomoLine® capnography, SedLine® brain function monitoring, O3® regional oximetry, and now the Centroid patient positioning tracker.

Joe Kiani, Founder and CEO of Masimo, said, "We are honored to continue to be able to equip Temple – one of the country's premier medical institutions – with so many of our life-saving solutions, from monitoring technologies like SET® pulse oximetry and rainbow® Pulse CO-Oximetry, to advanced monitors like Root and Hospital Automation solutions like Patient SafetyNet. With the addition of Centroid, Temple adds another key Masimo innovation to their toolkit. It's a great example of our commitment to developing new ways to provide the highest quality, most relevant data to clinicians in the most intuitive, useful formats. We look forward to helping Centroid prevent many HAPIs and improve the outcomes and lives of their 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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.13 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. 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 https://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. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

About Temple University Hospital

Temple University Hospital's mission is to provide access to the highest quality of health care in both the community and academic settings. The 722 bed academic medical center supports Temple University and its Health Sciences Center's academic programs by providing the clinical environment and service to support the highest quality teaching and training programs for health care students and professionals, and to support the highest quality research programs. The hospital's values are simple: Respect, Service and Quality. Temple University Hospital – Main Campus (TUH) is a nationally respected academic medical center that offers high-quality care, the latest technology and skilled staff – all on a safe, easy-to-reach campus. As the chief clinical training site for the Lewis Katz School of Medicine at Temple University, TUH is a teaching hospital where the latest procedures and techniques are pioneered and where students and other physicians come to learn. It is also a robust research center that is advancing the fight against disease, pushing the boundaries of medical science and altering the course of serious disease. All of this means that Temple physicians and staff are at the forefront of medical knowledge. TUH is many things to many kinds of patients. For some, it's the hospital they depend on for their routine medical care. For others, it's a place to receive specialized, lifesaving treatments that can’t be found at most hospitals. Temple’s nationally renowned medical staff offer dozens of powerful new options for patients who, just a few years ago, were considered untreatable. So whether a patient needs a family doctor or a highly trained specialist, chances are good they can find that physician at Temple. Although surrounded by modern equipment and state-of-the-art facilities, it's notable that Temple physicians and staff never lose sight of what is most important – patients and their families. This personalized approach to care makes the hospital a true medical home for hundreds of thousands of patients each year.

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 Centroid™. 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 Centroid, 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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Retrospective Study Finds That Masimo SET® Pulse Oximetry Has No Difference in Accuracy or Bias Between Black People and White People

Irvine, California - January 17, 2022 - Masimo (NASDAQ: MASI) today announced the findings of an abstract presented last Saturday at the Society for Technology in Anesthesia 2022 Annual Meeting, which reviewed retrospective pulse oximetry data and concluded that there was no clinically significant bias based on ethnicity for black and white volunteer subjects monitored with Masimo SET® pulse oximetry and RD SET® sensors.1

Masimo Root® with O3® Regional Oximetry and SedLine® Brain Function Monitoring

Masimo SET® Pulse Oximetry with RD SET® Sensors

A 2020 letter to the editor2 and paper3 purported to find "racial bias" in pulse oximetry measurements, based upon a comparison of data obtained from black and white patients compiled from multiple sets of health record data, using unspecified pulse oximeters and controls. Masimo Founder and CEO Joe Kiani responded to the letter and promised additional research to test Masimo's understanding of the subject and hypothesis about the performance of Masimo technology. The first of such studies was conducted and reported by Dr. Steven J. Barker (Chief Science Officer, Masimo) and Dr. William C. Wilson (Chief Medical Officer, Masimo). Drs. Barker and Wilson performed a retrospective analysis of Masimo laboratory data obtained from black and white volunteer subjects, in an effort to identify differences in Masimo pulse oximeter accuracy and bias between ethnic groups.

The authors reviewed data collected between October 2015 and July 2021, which included 7,183 paired samples (3,201 black and 3,982 white) collected from 75 subjects (39 black and 36 white), who were screened with the same criteria to remove potential bias based on health conditions. All subjects were exposed to the same hypoxia protocol, which varied the arterial saturation of hemoglobin (SaO2) between 70% and 100%. Noninvasive oxygen saturation (SpO2) values were obtained from Masimo SET® pulse oximeters with RD SET sensors and time-matched (within 5 seconds, rather than up to 10 minutes as in the letter to the editor) with arterial blood gas (ABG) samples analyzed using an ABL-835 blood gas analyzer.

The authors analyzed the data to determine the bias (the mean difference in paired SpO2 and SaO2 samples), precision (standard deviation of the difference), and accuracy (root mean squared error, ARMS*) for both groups. They found a negative bias of 0.20% for black subjects, compared to a negative bias of 0.05% for white subjects, a difference of 0.15% (p < 0.001), which is not clinically significant and is numerically indistinguishable because the SpO2 display resolution is 1% on commercially available pulse oximeters (both from Masimo and other manufacturers). They found precision of 1.40% for black subjects and 1.35% for white subjects. Accuracy (ARMS) was 1.42% for black subjects and 1.35% for white subjects. These results are consistent with the accuracy specifications of RD SET sensors (1.5% accuracy ARMS).

By comparison to the Masimo finding of 0.15% difference in bias between black and white subjects, the 2020 letter to the editor reported a difference in bias of 8.1% in a cohort of black and white hospital patients2 – 54 times higher than the Masimo result.

Masimo is conducting additional studies and will report its findings in the future.

@Masimo || #Masimo

*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within
+/-ARMS of the reference measurements in a controlled study.

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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 2021-22 U.S. News and World Report Best Hospitals Honor Roll.12 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient's physiological status. 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® and Radius PPG™, 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 automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, Patient SafetyNet, Replica®, Halo ION™, UniView®, UniView :60™, and Masimo SafetyNet®. Additional information about Masimo and its products may be found at https://www.masimo.com. Published clinical studies on Masimo products can be found at https://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. Barker SJ, Wilson WC. Accuracy of Masimo SET® Pulse Oximetry in Black and White Volunteer Subjects: A Retrospective Review. Annual Meeting of the Society of Technology in Anesthesiology. Presented Jan 15, 2022.
  2. Sjoding MW, et al: Racial Bias in Pulse Oximetry Measurement. N Engl J Med 2020; 383 (25):2477-2478.
  3. Valbuena VSM, et al: Racial Bias in Pulse Oximetry Measurement Among Patients About to Undergo ECMO in 2019-2020, A retrospective Cohort Study. Chest 2021 Sep 27; S0012-3692(21)04065-4.
  4. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://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. http://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 SET® and RD SET®, and Masimo's plan to conduct additional studies on the accuracy of Masimo SET® and RD SET on black people and white people ("Additional Studies".) 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 SET® and RD SET, contribute to positive clinical outcomes and patient safety; risks that Masimo fails to conduct Additional Studies as planned; 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
Evan Lamb
Phone: (949) 396-3376
Email: elamb@masimo.com

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