Masimo Receives FDA Clearance for Stork™ Baby Monitoring System

Stork Provides Continuous Monitoring of Oxygen Saturation, Pulse Rate, and Skin Temperature, with Alarms, for Sick and Healthy Babies at Home

Masimo (NASDAQ: MASI), a global leader in innovative monitoring technologies used in top hospitals, announced today FDA clearance of Stork™, a revolutionary baby monitoring system, for prescription use with healthy and sick babies 0-18 months of age. Leveraging the same Masimo sensor technology that monitors more than 10 million babies in hospitals every year, Stork provides continuous, accurate monitoring of a baby’s health. Stork is available at retailers nationwide as a non-medical device for general health and wellness purposes. With this clearance, Stork is now available for prescription use to continuously monitor babies at home as a medical device for healthy or sick babies.

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Masimo Stork™ (Photo: Business Wire)

“When my son was born, we were concerned about his breathing. Our doctor prescribed pulse oximetry monitoring for a week for him. A therapist arrived at our home with a large standalone pulse oximeter made for hospitals, with cables and wires everywhere and tethered to our son, and charged us $5,000 for a week of monitoring,” said Joe Kiani, Founder and CEO of Masimo. “I know how important it is for parents to better understand their baby’s physiological well-being, especially when they are sick, and it’s our privilege to provide them with an easy-to-use, accurate product that allows them to continuously monitor key vital signs for less than one tenth of the cost I paid, and also includes video surveillance.”

When prescribed, parents and family members will now be able to receive alarms regarding their baby’s oxygen saturation (SpO₂), pulse rate (PR), and skin temperature. They will be able to share these vital signs data remotely with clinicians. In addition, Stork alerts parents if their baby turns over and is sleeping face down, which can be dangerous for babies.

Stork leverages the same technology that has been used on babies in the neonatal intensive care unit (NICU) for years, helping to improve health outcomes for the youngest and most vulnerable patients. Known as Signal Extraction Technology^®, or SET^®, this technology has helped clinicians reduce the incidence of neonatal blindness from retinopathy of prematurity¹ and has led to significant improvements in screening newborns for critical congenital heart disease.² Stork’s SpO₂ performance specification is industry-leading, at 1.5% A_RMS* at one standard deviation, even during motion.

This patented sensor technology nests within the Stork boot, which is made from an ultra-soft, medical-grade silicone that conforms gently to the baby’s skin and is available in three sizes to ensure a perfect fit as the child grows. The sensor embedded in the boot is the product of meticulous engineering that harnesses decades of expertise in non-invasive monitoring to detect babies’ SpO₂, PR, and skin temperature continuously with unprecedented accuracy and dependability.

With a sleek, minimalistic design ideal for any nursery aesthetic, the Stork Vitals+ bundle includes the boot with sensor that monitors baby’s skin temperature, pulse rate, and oxygen saturation, and a 2K Quad High-Definition (QHD) capable camera with technology supported by the TODA platform from Like Minded Labs. The camera hardware and software architecture are designed to leverage and be compatible with future edge AI-based features, in development. For those who do not require streaming video, the Stork Vitals bundle replaces the camera with a health hub, which connects the Stork vital signs sensor/boot to the Stork app, while still allowing parents to hear and speak to their baby. Stork also monitors the temperature of the baby’s room.

Dr. Ryan S. Bode, a national leader in pediatric hospital medicine and pediatric quality and safety, commented, “I have cared for hospitalized children for over 20 years. In addition, my passion and research interests have focused on quality improvement and patient safety in delivering high value pediatric care and ensuring optimal patient outcomes. Masimo SET^® pulse oximetry technology is unmatched in its ability to measure accurately even when children move or have low perfusion. Any caregiver, parent, or clinician looking to monitor key vitals in young babies should ensure they have accurate, reliable technology, like SET^® pulse oximetry.”

Dr. Mitchell R. Goldstein, Professor of Pediatrics at Loma Linda University, said, “I had the privilege of having access to one of the earliest Masimo SET^® pulse oximeters. A young baby, Joshua, came to our unit at extremis, and we attempted all life-saving measures to get his pulse on a non-Masimo device. With no success, we then tried the Masimo monitor and were able to get readings of his vitals, a signal that we should continue to provide care. Joshua survived and was eventually sent home with his parents, and our unit has relied on Masimo SET^® ever since. It is the only pulse oximeter I’m aware of that has provided the ability from the beginning to measure through challenging conditions and with darker skin colors, as was the case with Joshua. I am glad to see this life-saving technology being expanded to the home.”

For non-medical use, Masimo Stork bundles are available for direct consumer purchase at MasimoStork.com and on shelves at major and specialty U.S. retailers. To access Masimo Stork’s FDA-cleared features, parents can discuss Stork with their child’s primary care physician or, in a soon-to-be-released update, online with a physician via the Masimo Stork App.

For prescription use, Masimo Stork is 510(k) cleared for the following intended use: Masimo Stork is a wearable device intended for the monitoring of multiple physiological parameters. Masimo Stork is intended to be used in home environments. Masimo Stork is indicated for the spot-checking and continuous monitoring of SpO₂ and PR in infants and neonates during no motion, motion, and low perfusion conditions. Masimo Stork is also indicated for continuous skin temperature measurements of infants and neonates.

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*A_RMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- A_RMS of the reference measurements in a controlled study.

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.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns² 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 as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.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^®, Masimo W1 Sport, and Masimo Stork™. 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. 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.
2. 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.
3. 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.
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 Stork^™ and SET^®. 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 Stork and 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 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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