Masimo Announces Full Market Release of Masimo SafetyNet-OPEN™

Easy-to-Implement Solution Helps Businesses, Schools, and Other Organizations Reopen Responsibly and Stay Open Safely During Infectious Illnesses

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the full market release of Masimo SafetyNet-OPEN™, a web and mobile app solution that helps businesses, schools, and other organizations screen, trace, and manage users as they face COVID-19 and other infectious illnesses, such as seasonal flu. SafetyNet-OPEN not only helps organizations bring their people back to the workplace responsibly, but stay open safely. Tailored for each organization’s safety protocols and needs, SafetyNet-OPEN is capable of covering all stages of back-to-work management, including risk screening, exposure contact tracing, and recovery management.

As a global leader in noninvasive patient monitoring technologies and advanced connectivity and automation solutions, Masimo is uniquely positioned to provide organizations with the tools to assist them in staying open safely. Trusted by leading hospitals to monitor more than 200 million patients each year,¹ Masimo, in the first phase of the COVID-19 pandemic, developed the Masimo SafetyNet™ remote patient management solution, now in use at hospitals around the world, to help keep patients and frontline workers safe. SafetyNet-OPEN builds on SafetyNet by scaling this patient management to the level of entire organizations, no matter the size. When escalation of care is needed, SafetyNet-OPEN can even integrate clinical monitoring using Masimo SafetyNet, in partnership with the organization’s health care provider or local hospital.

Masimo SafetyNet-OPEN helps organizations identify those who are most at risk of COVID-19 or other infectious viruses, trace possible exposure to limit the spread of the virus, and monitor users’ vital signs, including temperature, to help detect the onset of fever, and arterial oxygen saturation, for signs of dangerous deterioration. Based on answers to daily questions and physiological data from connected monitoring devices, users receive a personalized daily risk score, automating directives to stay home, get tested, or seek treatment, configured according to each organization’s safety protocols, back-to-work procedures, and changing local health authority guidelines.

Flexible and versatile, the Masimo SafetyNet-OPEN system can be augmented with additional components to offer more advanced management of the organization’s users. To help screen potentially infected users, results from on-site testing, implemented in coordination with a trusted lab partner, can be securely stored and taken into account in risk scoring and assessment. To improve contact tracing, SafetyNet-OPEN can be customized with proximity wristbands or with the Radius Tº™ wearable continuous thermometer for both temperature measurement and proximity analysis, to help track users’ exposure to those who may be at risk, including time spent in close contact. And when care escalation may be needed, the organization, in collaboration with a trusted clinical partner, can easily incorporate vital signs data into SafetyNet-OPEN, to monitor impacted users as their risk level rises or during recovery from COVID-19, flu, or another illness. Data can be collected from the Radius Tº continuous thermometer (to help track fever), the Radius PPG™ wearable continuous pulse oximeter, and other monitoring devices.

For businesses, schools, and organizations both large and small, Masimo SafetyNet-OPEN is easy and fast to implement, with no desktop software to install and with a dedicated Masimo support team to ensure seamless rollout. A web-based workforce management dashboard provides a clear picture of every team member’s status – who’s at risk, who’s recovering, who’s cleared to work, proximity violations, etc. – helping organizations efficiently and safely manage their teams during COVID-19 and beyond. Every aspect, from the daily risk-assessment questions, to the rules of the algorithm that determines risk scores, to group assignments for contact tracing, and more, can be easily customized. Furthermore, SafetyNet-OPEN is designed to ensure user data is secure.

Dr. Richard Carmona, MD, MPH, 17th Surgeon General of the United States and Distinguished Professor of Public Health at the University of Arizona Mel and Enid Zuckerman College of Public Health, said, “One of Masimo SafetyNet-OPEN’s greatest strengths is its great versatility and customizability, which gives it enormous potential to provide utility in so many settings. As a former Surgeon General I can see tremendous application across a number of federal agencies whose day-to-day operation and 24/7 capability we all depend upon. At the University of Arizona, where I lead the effort to safely reopen our campuses, we’ve been involved in numerous initiatives examining how COVID-19 affects social groups – for example, the effects of asymptomatic carriers, and how to prevent ‘superspreader’ events. SafetyNet-OPEN’s risk assessment and mitigation tools, which can be fine-tuned to accommodate our evolving understanding of the disease, are ideal for better understanding and coping with such a complex challenge.”

Claremont McKenna College President Hiram E. Chodosh, JD, said, “We are grateful to Masimo for the pilot use of its SafetyNet-OPEN tools, which we believe provide yet another important way for us to strengthen the health and safety capabilities of our college campus and the broader community.”

Dr. Mark Ferris, MSc, MRCGP, MFOM, Occupational Physician, UK, commented, “Over the last year, we have gained considerable knowledge about COVID-19 and how best to control it. It is clear that to protect our colleagues or students, their families, our workplaces, and the wider community, we need to combine as many strategies as possible. These include the provision of accurate information, physical distancing, masks, ventilation, hygiene precautions, testing and monitoring, contact tracing, and supported isolation. The Masimo SafetyNet-OPEN solution offers a vital way to help organizations apply this combined strategy.”

Filmmaker Mark Kassen, Co-Founder and Executive Chairman of Like Minded Media Ventures, added, “We are all anxious to get back to work but without Masimo SafetyNet-OPEN, which we used during its limited market release, we never would have felt safe and secure enough to ask our cast and crew to come back to set.”

Dr. Oscar San Román Orozco, MD, COVID-19 Clinic, University Health System, Universidad Autonoma de Queretaro, Mexico, explained, “Public Health interventions never work in silos, because pandemics don’t just affect one sector. To overcome the challenges that COVID-19 has given us, we need a robust systematic approach that involves intersectoral, evidence-based interventions and technology. Masimo SafetyNet-OPEN provides employers and university leaders with the necessary tools to make their communities feel safe through an organized, controlled, and monitored strategy. We might not eradicate the disease soon, but we can control it by segmenting work and social groups based on their risk, monitoring these social bubbles using a robust screening and contact tracing method, and trusting in new intersectoral approaches and technologies. These will allow us to delimit the viral propagation and maintain tight control in case any individual gets infected.”

Joe Kiani, Founder and CEO of Masimo, said, “As the COVID-19 pandemic continues, organizations around the world are struggling with the immense challenge of balancing the health and safety of employees, students, and members with the economic and educational needs of their communities. Masimo has developed numerous technologies to help patients and clinicians stay safe during the pandemic. With SafetyNet-OPEN, we’ve combined our decades of expertise in patient monitoring with our latest innovations in automation and connectivity to help organizations confront this challenge and better manage future ones.”

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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.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,¹ and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 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^®, 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. Estimate: Masimo data on file.
2. Published clinical studies on pulse oximetry and the benefits of Masimo SET^® can be found on our website at 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. 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 SafetyNet-OPEN™, Radius Tº™, and Radius PPG™. 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-OPEN, Radius Tº, and Radius PPG, 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.