Masimo SafetyNet^® Reduced Mortality Among COVID-19 Patients

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 physical location (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.

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Masimo SafetyNet® (Photo: Business Wire)

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.

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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.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, iSirona™, Patient SafetyNet, Replica^®, Halo ION™, UniView^®, UniView :60™, and Masimo SafetyNet^®. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

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

References

1. 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
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 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.
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 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.

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