New Study Evaluates the Utility of Masimo ORi™ in Reducing Hyperoxemia During Laparoscopic Gastrectomy

Masimo (NASDAQ: MASI) today announced the findings of a prospective, double-blinded, randomized controlled study published in Medicine in which Dr. Jin Hee Ahn and colleagues at the Sungkyunkwan University School of Medicine in Seoul, Korea, evaluated the ability of Masimo ORi™ to assist clinicians in guiding supplemental oxygenation during elective laparoscopic gastrectomy surgery. The researchers found that the combination of ORi and standard of care oxygen saturation (SpO₂) monitoring reduced hyperoxemia compared to SpO₂ monitoring alone.¹

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ORi, available outside the U.S. since 2014, is a noninvasive and continuous parameter intended to provide additional insight into a patient’s oxygen status under supplemental oxygen. Enabled by the multi-wavelength rainbow^® Pulse CO-Oximetry platform, ORi is provided alongside SpO₂ measured by clinically proven Masimo SET^® pulse oximetry.

Noting that the use of supplemental oxygen during general surgery increases the risk of hyperoxemia, the researchers sought to evaluate whether noninvasive, continuous ORi might improve clinicians’ ability to detect hyperoxemia, since SpO₂ monitoring alone cannot monitor beyond 100% saturation, and since arterial blood gas analysis has the disadvantages of being invasive and giving intermittent, delayed results. To test their hypothesis, the researchers randomly allocated 62 adult patients scheduled for elective laparoscopic gastrectomy into two groups, one whose fraction of inspired oxygen (FiO₂) during anesthesia was guided by ORi and SpO₂ monitoring (the ORi-SpO₂ group, n=30), and a control group whose FiO₂ was guided by SpO₂ monitoring alone (the SpO₂ group, n=32). Patients in both groups were monitored with Masimo Radical-7^® Pulse CO-Oximeters^® with rainbow^® sensors. In addition to Masimo ORi and SET^® SpO₂, Masimo PVi^® (pleth variability index) was monitored as part of goal-directed fluid management.

In the ORi-SpO₂ group, FiO₂ was adjusted to maintain ORi > 0 and < 0.3, which was evaluated every 2 to 3 minutes throughout surgery. In the SpO₂ group, FiO₂ was adjusted to maintain SpO₂ ≥ 98%, similarly evaluated every 2 to 3 minutes. To assess the incidence of hyperoxemia, the clinicians recorded the arterial partial pressure of oxygen (PaO₂), measured using an ABL-90 FLEX Plus blood gas analyzer, before surgical incision and one, two, and three hours after surgical incision. Hyperoxemia was defined as PaO₂ ≥ 100 mmHg and severe hyperoxemia as PaO₂ ≥ 200 mmHg.

The researchers found that one hour after surgical incision, PaO₂ was higher in the SpO₂ group (250.31 ± 57.39 mmHg) than in the ORi-SpO₂ group (170.07 ± 49.39 mmHg) (p < .001), and remained consistently higher in the SpO₂ group than in the ORi-SpO₂ group over time (p = .045). The rate of severe hyperoxemia was higher in the SpO₂ group (84.4%) than in the ORi-SpO₂ group (16.7%) 1 hour after incision (p < .001).

The researchers concluded, “[I]ntraoperative hyperoxemia was reduced when FiO₂ was adjusted based on the combination of SpO₂ and ORi compared with SpO₂ alone in patients undergoing laparoscopic gastrectomy.”

ORi has not yet received FDA clearance and is not available in the United States.

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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.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.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ 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.¹⁰ 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. Ahn JH, Shim J-G, Park J, Lee SH, Ryu K-H, Cho E-A. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine. October 2022. DOI: 10.1097/MD.0000000000031592.
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. 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.
4. 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.
5. 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. 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.
8. 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.
9. Estimate: Masimo data on file.
10. 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 ORi™, SET^®, rainbow^®, and Radical-7^®. 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 ORi, SET®, rainbow^®, and Radical-7^®, 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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Contact information

Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com