Masimo Announces CE Marking of the Rad-G™ with Temperature

Masimo (NASDAQ: MASI) today announced the CE marking of the Rad-G™ with Temperature, a rugged handheld device that provides clinically proven SET^® pulse oximetry, respiration rate from the pleth (RRp^®), and other important parameters alongside clinical-grade, non-contact infrared thermometry. With its long-lasting rechargeable battery, robust rubber casing, light weight, and integrated noninvasive, real-time forehead temperature measurement, Rad-G with Temperature makes it easier for clinicians to quickly assess patients and make informed care decisions anywhere pulse oximetry or vital signs checking is needed in a compact, portable form factor. Coupled with the universal Mini-Clip™ pulse oximeter sensor to provide the ultimate in handheld versatility, Rad-G with Temperature can be used in a variety of settings, including but not limited to entry screening, physicians’ offices, outpatient services, long-term care facilities, wellness clinics, first-response scenarios, and limited-resource environments both indoors and in the field. Rad-G can provide both spot-check measurement and continuous monitoring.

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Masimo Rad-G™ with Temperature (Photo: Business Wire)

The infrared thermometry offered by Rad-G with Temperature provides a host of benefits. Rad-G’s thermometer is non-contact and does not require probe covers or other disposable accessories. Its integration into the Rad-G platform eliminates the need for clinicians to locate a separate clinical thermometer to take body temperature measurements and ensures that many people can be seamlessly and efficiently screened for temperature, with one-touch operation, alongside oxygen saturation, respiration rate, and more, in the same session, using a single device. Designed from the start to maximize portability and battery life, Rad-G’s rechargeable battery provides an impressive 24 hours of continuous use between charges – allowing clinicians to work in transport, emergency, and other challenging scenarios with confidence that the device will continue to function hour after hour.

First developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device for use in pneumonia screening, the Rad-G with Temperature expands on its predecessor’s capabilities not only with the ability to measure temperature, but the addition of alarms, and thus the ability to provide both continuous monitoring and spot-check measurement – without sacrificing any portability, convenience, or ruggedness. Using the included power adapter, Rad-G can be easily converted from a handheld, spot-check device into a continuous monitoring device, in the absence of other multi-parameter monitors. As of 2010 – twenty years after use of pulse oximetry during surgery became routine in affluent countries – more than 77,000 operating theaters in low- and middle-income countries were still conducting surgery without pulse oximetry.¹ Working with a myriad of non-profit organizations, Rad-G is being made available at an affordable price so that the five billion people who don’t have access to reliable pulse oximetry can finally have it. When used for continuous monitoring, the high-resolution screen displays a continuous pleth waveform and the fully configurable, audible alarms help alert clinicians to changes in patient status that may require their intervention.

The development of Rad-G stems in part from the findings of a multi-center, prospective, two-stage observation study funded by The Bill & Melinda Gates Foundation, whose protocols were published in JMIR Research Protocols, in which Dr. Kevin Baker, MA, MSc, Senior Research Specialist at the Malaria Consortium, and colleagues sought to identify the most accurate, usable, and acceptable devices to aid community health workers in the diagnosis of pneumonia symptoms in resource-poor settings.² The researchers found that “The Masimo mobile phone pulse oximeter [iSpO₂^® Rx] had the best overall performance across all measures and in both age strata of the children the device was tested on. This may be due to the motion signal processing techniques incorporated in Masimo pulse oximeters which attempts to reduce motion artefact, which may be particularly important when using these devices on moving children.”³

Paul Farmer, Kolokotrones University Professor at Harvard, Chair of the Department of Global Health and Social Medicine at Harvard Medical School, Chief of the Division of Global Health Equity at Brigham and Women’s Hospital in Boston, and Co-Founder and Chief Strategist of Partners in Health, said, “In the places where I’ve worked around the world, there has always been a demand for tools that enable the continuous monitoring of key vital signs, like respiration rate, oxygen saturation, and temperature, which can help providers and patients fight against illnesses from pneumonia to congenital heart disease.”

Eric D. McCollum, MD, MPH, Director of the Global Program in Respiratory Sciences at the Johns Hopkins School of Medicine in Baltimore, Maryland, said, “The Masimo Rad-G is a fantastic device that is thoughtfully crafted and user-friendly for both healthcare workers with diverse training backgrounds and pediatric patients across the age spectrum. We are using the Rad-G currently in four countries in our pediatric global health work and the device is no doubt at the high standards set by Masimo with its range of high-quality pulse oximeters. The healthcare providers and children love it.”

“Bacterial and viral pneumonias – including those caused by COVID-19 – are a leading cause of death in children and adults globally, with a disproportionate burden of disease in low-resource settings,” said Peter Moschovis, MD, MPH, a pulmonologist at Massachusetts General Hospital. “Pulse oximetry plays an important role in the triage and management of patients with pneumonia.”

Joe Kiani, Founder and CEO of Masimo, said, “With Rad-G, we set out to create an accessible, high-quality care solution that clinicians can rely on in a multitude of care settings to serve the five billion people on our planet that to date have not had access to pulse oximetry, let alone SET^® pulse oximetry. With the addition of temperature measurement, Rad-G is more versatile than ever, streamlining the assessment of multiple key vital signs. Many caregivers travel miles, sometimes on bike, sometimes on foot, to help patients, so having a product that is light, small, multifunctional, and ‘accurate when you need it most’ is crucial. Rad-G was designed to be just that.”

SpO₂ and PR monitoring on Rad-G is provided using clinically proven Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other technologies.⁴ SET^® is estimated to be used on more than 200 million patients a year⁵ and is the primary pulse oximetry at 9 of the 10 hospitals that top the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.⁶ With Masimo SET^® technology in Rad-G, clinicians have access to accurate pulse oximetry measurements in the palm of the hand.

In a new cross-sectional study published in Acta Paediatrica, Dr. Baker and colleagues assessed the utility of Rad-G by observing how it was used by healthcare workers screening children under five for pneumonia in three regions of Ethiopia in 2018.⁷ The researchers found that healthcare workers gave correct treatment and referral guidance using Rad-G’s results and their assessment of other symptoms in 94.9% and 95.8% of cases in the first and second of their two observation groups, respectively.

In addition to temperature measurements and Masimo SET^® oxygen saturation (SpO₂), pulse rate (PR), perfusion index (Pi), and PVi^® (for assessing fluid responsiveness), the same SpO₂ sensor can be used to monitor respiration rate from the plethysmograph, with RRp. Difficulty breathing and fever are generally considered two of the earliest signs of patient deterioration, and Masimo hopes that the availability of RRp and thermometry on Rad-G may play a role in assisting clinicians and public health officials as they seek to combat numerous types of illnesses, including pneumonia and COVID-19.

Rad-G with Temperature can be used with a variety of reusable and single-patient use sensors. The universal direct-connect Rad-G reusable sensor, indicated for monitoring adult, pediatric, and infant patients, helps to eliminate the need to stock and carry multiple sensor types, increasing the device’s versatility and ease of use, especially in more challenging field environments. Rad-G with Temperature is also compatible with the vast portfolio of Masimo single-patient-use adhesive sensors—including Masimo RD SET^® sensors, which offer best-in-class accuracy specifications of 1.5% in conditions of motion and no motion—ensuring clinicians can customize their setup based on the unique needs of each care setting. In addition, Rad-G is designed to work reliably on all people, from white to black, neonate to geriatric.

Rad-G is FDA 510(k) cleared and is available in the U.S. Rad-G with Temperature has not received FDA 510(k) clearance and is not currently available in the U.S. PVi is FDA 510(k) cleared as an indicator of fluid responsiveness in select populations of mechanically ventilated adult patients in the U.S.

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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,⁸ improve CCHD screening in newborns,⁹ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^10-13 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁵ 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.⁶ 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. https://www.theatlantic.com/health/archive/2017/02/pulse-oximeter/516510/
2. Baker K, Akasiima M, Wharton-Smith A, Habte T, Matata L, Nanyumba N, Okwir M, Sebsibe A, Marasciulo M, Petzold M, Källander K. “Performance, Acceptability, and Usability of Respiratory Rate Timers and Pulse Oximeters When Used by Frontline Health Workers to Detect Symptoms of Pneumonia in Sub-Saharan Africa and Southeast Asia: Protocol for a Two-Phase Multisite, Mixed-Methods Trial.” JMIR Res Protoc. 2018;7(10):e10191) doi: 10.2196/10191.
3. https://openarchive.ki.se/xmlui/bitstream/handle/10616/46833/Thesis_Kevin_Baker.pdf?sequence=4&isAllowed=y
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. Estimate: Masimo data on file.
6. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
7. Baker K, Ward C, Maurel A, de Cola M, Smith H, Getachew D, Habte T, McWhorter C, LaBarre P, Karlstrom J, Ameha A, Tariku A, Black J, Bassat Q, Kallander K. “Usability and acceptability of a multimodal respiratory rate and pulse oximeter device in case management of children with symptoms of pneumonia: A cross-sectional study in Ethiopia.” Acta Paediatrica. 19 Nov 2020. DOI: 10.1111/apa.15682
8. 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.
9. 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.
10. 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.
11. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
12. 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.
13. 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.

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 Rad-G™, SET^®, RRp^®, and iSpO₂^® Rx. 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 Rad-G, SET^®, RRp, and iSpO₂ Rx, 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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