Telehealth System Combines Radius PPG™ Tetherless Pulse Oximetry and the Doctella™ Platform

IRVINE, Calif. & CLEVELAND--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) and University Hospitals (UH), one of the largest health systems in Northeast Ohio, today jointly announced Masimo SafetyNet™, an innovative, economically scalable patient management system designed to help clinicians care for patients remotely.

The telehealth solution combines tetherless Radius PPG™ pulse oximetry, driven by breakthough Masimo SET^® Measure-through Motion and Low Perfusion™ technology, with Doctella™, a secure, home-based, remote patient surveillance platform accessible from a patient’s iOS or Android smartphone or smart device.

The COVID-19 health emergency has significantly increased the demand for remote monitoring and patient engagement solutions in multiple settings. To proactively prepare for a surge in COVID-19 patients while maintaining the safety of other patients and providers, this new solution allows UH and other hospitals to expand patient monitoring to the home or to other facility locations set up temporarily to care for the increased demand. Current WHO guidelines recommend the monitoring of suspected or confirmed COVID-19 patients’ oxygen saturation (SpO₂), respiration rate (RR), and temperature, and Masimo and UH are meeting this increased demand by adapting existing technology to deliver a secure remote solution.

Masimo SafetyNet offers care teams a single-platform solution that couples a secure, cloud-based surveillance platform with clinically proven SET^® pulse oximetry, estimated to be used on more than 200 million patients each year.¹ In addition to SpO₂, Radius PPG is capable of continuously monitoring pulse rate (PR), perfusion index, PVi^®, and RRp^®, respiration rate from the photoplethysmograph.

Patients can be sent home with a multi-day supply of single-patient-use Radius PPG sensors and access to the Doctella mobile app, designed for easy, intuitive patient use via a digital home-care plan, or CareProgram, that aligns with expert guidance on COVID-19. Radius PPG shares its SpO₂, PR, and RRp data with Doctella using secure Bluetooth^® wireless technology. In addition, Doctella can manually collect other physiological data, such as temperature. Twice daily, or as directed, the Doctella CareProgram actively notifies patients to answer questions such as, “are you having trouble breathing?” and “what is your temperature?”, and securely pushes these responses along with physiological monitoring data to hospital-based clinicians for evaluation. The Doctella clinician portal allows providers to easily track patient compliance, helping them identify when intervention may be needed, as well as providing insight to help providers prioritize patients. CarePrograms are fully customizable to accommodate each institution’s protocols, each patient’s needs, and any changes in COVID-19 guidance—and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve.

“We appreciate Masimo’s immediate collaboration to stand up this innovative platform that will significantly aid in our ability to scale up remote monitoring and meet the demand for patient care while addressing capacity and safety issues,” explained Peter Pronovost, MD, UH Chief Clinical Transformation Officer. “For our patients with congestive heart failure or chronic obstructive pulmonary disease (COPD), we can provide them with this remote monitoring capability so they do not risk a COVID-19 infection by being near potentially infected patients. Similarly, for patients with a confirmed COVID-19 diagnosis, we can appropriately isolate them from other patients while ensuring they have the access to state-of-the-art care for managing their health through the recovery process.”

Joe Kiani, Founder and CEO of Masimo, said, “We thank the nurses and doctors who are bravely toiling in hospitals taking care of us all during this pandemic. We are delighted that we can help them triage and effectively take care of COVID-19 patients the best they can with Masimo SafetyNet. It has been a delight to work with UH to bring this technology to the health care industry to help them address the challenges they face during this unprecedented time.”

“This alliance demonstrates UH’s strategy to drive improvements in population health,” said Daniel I. Simon, MD, UH Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center. “By deploying ‘outside-in’ tactics and forming this partnership with Masimo, our patients receive cutting edge treatment approaches while we help enhance the product for future users and industry transformation.”

UH plans to begin piloting this system next week.

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.^5-7 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 2019-20 U.S. News and World Report Best Hospitals Honor Roll.⁸ 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 Iris^® platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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. Taenzer AH 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.
4. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP 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.
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. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

About University Hospitals

Founded in 1866, University Hospitals serves the needs of patients through an integrated network of 18 hospitals, more than 50 health centers and outpatient facilities, and 200 physician offices in 16 counties throughout northern Ohio. The system’s flagship academic medical center, University Hospitals Cleveland Medical Center, located in Cleveland’s University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children’s hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; University Hospitals Harrington Heart & Vascular Institute, a high-volume national referral center for complex cardiovascular procedures; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including “America’s Best Hospitals” from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals – part of The Harrington Project for Discovery & Development. UH is one of the largest employers in Northeast Ohio with 28,000 physicians and employees. Advancing the Science of Health and the Art of Compassion is UH’s vision for benefitting its patients into the future, and the organization’s unwavering mission is To Heal. To Teach. To Discover. Follow UH on LinkedIn, Facebook @UniversityHospitals and Twitter @UHhospitals. For more information, visit UHhospitals.org.

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™, Radius PPG™, Doctella™, SET^®, and RRp^®. 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, Radius PPG, Doctella, SET^®, and RRp, 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.

Contacts

Media Contacts:
Masimo
Evan Lamb

949-396-3376

[email protected]

University Hospitals
George Stamatis

216-844-3667

[email protected]