Leading French Healthcare Facility Adopts an Innovative Telemonitoring Platform as Part of a Mobile Neonatology Unit for the Monitoring of Premature Newborns, Serving Both Patients and Caregivers

Masimo (NASDAQ: MASI) today announced that Saint-Denis Hospital Center is adopting the use of the Masimo SafetyNet^® cloud-based telemonitoring platform as part of an experimental mobile neonatology unit aimed at facilitating earlier discharge of premature newborns from the ICU to the home. Launched in February, this pioneering project allows vulnerable neonates to return home safely to their families while remaining under the close supervision of the hospital.

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Masimo SafetyNet® and Saint-Denis Hospital Center, Delafontaine (France) (Photo: Business Wire)

Masimo SafetyNet offers a streamlined approach to remote patient management that can be scaled and tailored to each patient’s unique care needs, offering wireless continuous monitoring and spot-check devices, customizable CarePrograms™ with symptom reporting, and a secure in-hospital clinical portal that allows care teams to keep watch over a large volume of patients. Following discharge, families are sent home with an easy-to-use pulse oximetry sensor, Radius PPG^®, powered by clinically proven Masimo Signal Extraction Technology^® (SET^®), and an intuitive smartphone application. The sensor, worn on the foot of neonatal patients, includes a chip that sends health data to the app, where parents can keep an eye on their baby’s condition and communicate with caregivers. From the hospital, caregivers receive that same data as well as notification logs about changes in a patient’s condition—enabling them to prioritize those who may need care escalation.

Staff members at Saint Denis were already familiar with the benefits of home-based care. Dr. Pascal Bolot, head of neonatal intensive care at Saint-Denis, first implemented home visits in partnership with the ARS, a regional health authority, to address the lack of care following hospital discharge and alleviate the distress of the abrupt shift from hospital to home for families. Saint-Denis’ experience providing home visits was a key advantage when it came to implementing remote neonatal monitoring, alongside 11 other French facilities taking part in the trial. With the integration of Masimo SafetyNet, the pilot has expanded its approach to be more comprehensive and innovative – an approach that, according to Dr. Alizée Lori, the pediatrician at Saint-Denis who oversees the mobile unit, “[brings] premature newborns into a secure home environment equivalent to hospital-grade monitoring quality.” The addition of this technology serves as an opportunity to “put the premature newborn back in the center of the family,” added Dr. Bolot.

The mobile neonatology unit benefits caregivers and families alike. As a general rule, neonatology services do not allow premature babies to return home before the end of 36 weeks of corrected age. Masimo SafetyNet may help make it possible to secure an earlier return home, serving as a relay between hospital staff and families and providing comprehensive support for premature babies in their first few weeks of life. The success of this program could lead to the deployment of Masimo SafetyNet in other care areas, particularly in pediatric care, including home patient management of various conditions.

Dr. Lori commented, “We chose this Masimo solution because of its innovative nature and the practical aspect of wireless physiological data monitoring; it’s easy for families to use and gives our medical team easy access to patients’ health data from the hospital. Since Masimo is used in many neonatology departments, including CH Delafontaine, we were confident in the reliability of the data recorded. This solution allows us to adapt care protocols to meet the needs of our vulnerable patients. Additionally, the Masimo team has supported us since the beginning of the project, and is still available on a daily basis.”

The Saint-Denis Hospital Center, made up of the Delafontaine and Casanova sites, is the only public healthcare facility in the Plaine Commune area, serving a population of 435,000 people. The facility offers 839 hospital beds with adult, pediatric and gynecological emergency services, a large consultation platform, and a type 3 perinatal center for monitoring high-risk pregnancies through high-quality maternal and neonatal care for mothers and children.

Joe Kiani, Founder and CEO of Masimo, said, “Our mission from the beginning has been to improve patient outcomes and reduce cost of care by taking noninvasive monitoring to new sites and applications. And it’s incredible to see how far we’ve come. To see parents be able to be with their newborn baby and each other is extremely gratifying, and to help the dedicated team at Saint-Denis provide earlier discharge yet keep the same level of monitoring is something we’re all proud of. Masimo has long fought to protect vulnerable newborns through innovative continuous monitoring, and it is truly rewarding to see how Masimo SafetyNet—using the same technology we’ve developed and perfected over 35 years—is helping Saint-Denis extend comprehensive care to neonatal patients at home. As healthcare becomes more predictive, preventative, and personalized than ever before, we are committed to innovating solutions that put patients at the center of the care ecosystem.”

@Masimo | #Masimo

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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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 all 10 top U.S. hospitals as ranked in the 2024 Newsweek World’s Best Hospitals listing.⁹ 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^®, Radius PPG^®, and Radius VSM™, 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^® and the Masimo W1^® Medical Watch. Masimo hospital and home 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^®. Its growing portfolio of health and wellness solutions includes Radius Tº^® and Masimo W1 Sport. 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/.

RPVi has not received FDA 510(k) clearance and is 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. 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.
8. Estimate: Masimo data on file.
9. https://www.newsweek.com/rankings/worlds-best-hospitals-2024/united-states

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^®, Masimo Radius PPG^®, and Masimo SET^® and the implementation of Masimo SafetyNet in Saint-Denis Hospital Center (the “Implementation”). 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, Masimo Radius PPG, and Masimo SET^®, 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 our belief of the success of the Implementation and that such success could lead to the deployment of Masimo SafetyNet in other areas; 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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