Masimo Announces Limited Market Release of Sepsis Index

(BUSINESS WIRE) -- Masimo (NASDAQ: MASI) today announced the limited market release of Sepsis Index (Si™), an early warning indicator designed to help clinicians identify possible sepsis in patients remotely monitored with Masimo Patient SafetyNet™. Patient SafetyNet, a powerful remote patient monitoring and surveillance system in use around the world, aggregates real-time physiological data from Masimo and third-party bedside monitoring equipment for display at central stations, allowing clinicians to monitor patient condition from afar. By continuously analyzing a variety of vital signs data and other clinical measurements together with EMR data captured by Patient SafetyNet, Si works by quantifying patient status in an easily interpretable sepsis risk score.

Sepsis Index, using the aggregated data from Patient SafetyNet, is designed to provide early warning of possible sepsis or other causes of deterioration in a patient’s condition, and to help track patient status following sepsis diagnosis and monitor the effectiveness of treatment and interventions. In addition, Si is designed to display on-screen decision support and recommended actions that each institution can update according to its sepsis policy. The Si algorithm is customizable and draws upon Masimo’s expertise in developing a variety of advanced early warning risk-scoring solutions, such as Halo and Halo ION^®, since 2009.

Sepsis, a life-threatening condition in which organs malfunction because of widespread infection, is not only common among hospital patients and is a common cause of death.¹ The CDC estimates that every year, about 1.7 million adults in the U.S. develop sepsis, of whom at least 350,000 die during their hospitalization or in hospice. One in every three patients who dies in a U.S. hospital had sepsis during their hospitalization.² Sepsis has also been described as the most expensive condition to treat in the entire U.S. healthcare system, with an estimated $24 billion in annual costs.³ Early detection of sepsis has been associated with decreased mortality.⁴ Masimo Si is designed to help clinicians detect physiologic deterioration associated with the onset of sepsis and track the progress of the patient’s condition during its duration.

Aldo Carmona, MD, Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care at St. Luke’s University Health Network, said, “Although there have been great advancements both clinically and technically, assessment and early identification of sepsis remain an elusive challenge. Masimo’s new indicator, Si, provides a continuous and real-time assessment of sepsis risk for a given patient based on the clinical measurements available from monitors and other EMR data (labs, medications, etc.). This could be a great addition in a hospital’s fight against the leading cause of in-patient mortality. By alerting the clinical staff to the risk of potential sepsis, it would allow for more timely intervention with life-saving resuscitation and medication. Likewise, tracking the patient state will help assess the effects of treatment and interventions so that we can improve appropriate allocation of hospital resources to patients and potentially identify patients who need escalation of treatment earlier.”

Joe Kiani, Founder and CEO of Masimo, “Masimo has always sought to solve those ‘unsolvable’ problems that need resolution. Detection of sepsis has long been one of the unsolved clinical problems, and one which we have spent considerable time and effort to remedy. With Sepsis Index, we hope to help doctors and nurses everywhere identify sepsis before it’s too late to treat it.”

Sepsis Index (Si) is not FDA cleared.

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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. 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.⁵ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁶ improve CCHD screening in newborns,⁷ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^8-11 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹² 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.¹³ 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^®. 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 the Masimo W1™ watch. 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, RPVi, and Radius VSM 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. Singer M et al. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA 2016.

2. https://www.cdc.gov/patientsafety/features/get-ahead-of-sepsis.html#:~:text=About%201.7%20million%20adults%20in,had%20sepsis%20during%20that%20hospitalization .

3. https://www.sepsis.org/news/new-u-s-government-report-reveals-annual-cost-of-hospital-treatment-of-sepsis-has-grown-by-3-4-billion/

4. Kim HI, Park S. Sepsis: Early Recognition and Optimized Treatment. Tuberc Respir Dis (Seoul). 2019 Jan;82(1):6-14. doi: 10.4046/trd.2018.0041. Epub 2018 Sep 28. PMID: 30302954; PMCID: PMC6304323.

5. 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.

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. 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.

9. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

10. 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.

11. 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.

12. Estimate: Masimo data on file.

13. 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 Si™ and Patient SafetyNet™. 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 Si and Patient SafetyNet, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; 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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