Masimo Expands the Masimo SafetyNet(TM) Remote Patient Management Solution with Continuous Body Temperature Measurement

Masimo (NASDAQ: MASI) today announced a significant expansion to the Masimo SafetyNet™ platform with the introduction of Radius Tº™, a wearable, wireless sensor that provides continuous body temperature measurements. By augmenting the already powerful Masimo SafetyNet, which features Radius PPG™ tetherless pulse oximetry, with Radius Tº, the remote patient management solution becomes capable of tracking four key vital signs – oxygen saturation, respiration rate, pulse rate, and now temperature – making it an ideal solution for assessing the status of patients with suspected or low-acuity COVID-19, among many other remote patient management uses. Unlike spot-check thermometry solutions, Radius Tº measures body temperature continuously, providing remote notifications when a patient’s temperature is outside a clinician-specified range – giving peace of mind to caregiver and patient alike.

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Masimo SafetyNet™ with Radius PPG™ and Radius Tº™ (Photo: Business Wire)

Masimo SafetyNet uses a tetherless, wearable single-patient-use Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry sensor to monitor a patient’s blood oxygen saturation and pulse rate, as well as respiration rate, perfusion index, and PVi®. Masimo SafetyNet is designed to help manage the surge in COVID-19 patients while maintaining distance from other patients and providers, allowing hospitals to expand remote patient monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. The telehealth platform combines tetherless pulse oximetry—and now also Radius Tº continuous temperature measurement – with a cloud-based remote data capture and surveillance platform accessible from a patient’s Android or iOS smartphone or smart device. Monitoring key physiological data provides clinicians with the ability to assess patient status and facilitates awareness of the need for intervention.

Temperature measurement by patients at home typically occurs intermittently, at the prompting of a clinician, and is prone to poor compliance in the collection and reporting of data to healthcare providers in a timely, consistent fashion. A patient taking their temperature at regular or semi-regular intervals may only notice a spike in temperature hours after a fever has begun, or may not even be aware of it, delaying possible clinical intervention. In contrast, Radius Tº collects data continuously and seamlessly, recording trend data and automatically notifying remotely when a clinician-specified high temperature threshold is breached, without any action needed on the patient’s part. By eliminating inconsistent manual measurements and concerns about patient compliance, while providing continuous insight into changes in body temperature, Radius Tº is intended to significantly improve patient status assessment workflows.

Radius Tº is small, light, and comfortable, and is easily applied to the chest. Each shower-proof, single-patient-use sensor lasts up to 8 days and can be worn throughout the day and night, allowing patients to continue normal daily activities while still being monitored. Applied to the skin, Radius Tº uses proprietary algorithms to measure the patient’s body temperature, not just external skin temperature, with laboratory accuracy within ±0.1ºC, whereas other thermometry solutions typically have laboratory accuracy within ±0.2ºC. Using Bluetooth®, Radius Tº provides this continuous data to the Masimo SafetyNet app on the patient’s smartphone and via secure cloud to clinicians back at the hospital, allowing them to track and trend a patient’s body temperature, helping them to spot potential deterioration in patient status using the web-based Masimo SafetyNet Clinician Portal.

Joe Kiani, Founder and CEO of Masimo, said, “We’re proud to add this noninvasive, continuous, wearable thermometer solution to our growing family of remote patient management solutions. Masimo SafetyNet has already helped clinicians effectively care for countless patients during the pandemic. With the addition of Radius Tº, Masimo SafetyNet becomes an even more useful tool for remotely managing patients with COVID-19 and many other health concerns.”

Radius Tº is indicated for use on patients 5 years and older. Radius Tº is not FDA 510(k) cleared; the device is marketed under the FDA’s Enforcement Policy for Clinical Electronic Thermometers During COVID-19.

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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.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 according to the 2019-20 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. 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™ and Radius Tº™. 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 and Radius Tº, 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.

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