New Study Investigates the Impact of ORi-Guided Oxygen Titration on Hyperoxemia-Mediated Morbidity During One-Lung Ventilation

Masimo (NASDAQ: MASI) announced today the findings of a study published in the Turkish Journal of Medical Sciences in which Dr. Ayten Saracoglu and colleagues at the Marmara University Pendik Training and Research Hospital in Istanbul evaluated the ability of ORi to guide oxygenation by measuring its impact on hyperoxemia-mediated morbidity during one-lung ventilation (OLV) conducted as part of thoracic surgery.¹ They concluded that ORi-guided oxygen titration “may reduce hospital stay and increase patient safety.”

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Masimo Root® with ORi™ (Photo: Business Wire)

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 oxygen saturation (SpO₂) measured by clinically proven Masimo SET^® pulse oximetry.

Noting that during OLV, a common technique for facilitating a wide variety of pulmonary procedures, 100% fraction of inspired oxygen (FiO₂) supplemental oxygen administration is commonly used, which exposes patients to the possibility of hyperoxia-induced lung injury, the researchers sought to determine whether ORi could “protect patient from the harmful effects of hyperoxemia with a noninvasive probe during OLV.” They divided 103 patients with lung tumors (18-70 years of age, ASA I-III), enrolled between September 2018 and September 2019 and requiring OLV as part of elective thoracic surgery, into four groups as noted below:

During OLV, oxygen titration was performed without ORi for patients in groups 1 and 2, while groups 3 and 4 used ORi from Masimo Radical-7^® Pulse CO-Oximeters^® and rainbow^® sensors. For all 4 groups, SpO₂ and partial pressure of arterial oxygen (PaO₂) were routinely measured while FiO₂ was routinely administered at 50% after induction, rising to 60% when the OLV was applied, and increasing to 70%-100% as necessary.

The researchers found that ORi monitoring was associated with significantly shorter duration of OLV with FiO₂ > 60%, with significantly lower mean FiO₂ values during OLV (as shown in the table above), and with lower recorded PaO₂ values. They also found that the duration of FiO₂ > 80% during OLV was strongly correlated with longer hospital stays (p < 0.001).

The observation that mean FiO₂ values were found to be significantly lower in the ORi groups (3 and 4), compared to the groups without ORi (1 and 2), led the researchers to hypothesize that “the risk of hyperoxia will be lower in patients undergoing ORi monitor[ing].” The researchers noted, “ORi cannot replace arterial blood gas analysis; however, it is useful to assess oxygenation. In groups without ORi monitors, the FiO₂ was significantly higher than 80%. Moreover, in our study, it was revealed that these patients had a longer hospital stay.”

There was no significant difference in ORi values between the low-flow (group 3) and high-flow (group 4) cohorts.

The researchers concluded, “The adjustment of ORi with peripheral oxygen saturation and blood gas analysis demonstrated that hyperoxemia could be prevented during OLV in patients under low flow or high flow anesthesia. We concluded that ORi-guided thoracic anesthesia may reduce hospital stay and increase patient safety.”

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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ 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 Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView^®, UniView :60™, and Masimo SafetyNet™. 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. Saracoglu A, Yamansavci Şirzai E, Yildizeli B, Yüksel M, Aykaç ZZ. Oxygen Reserve Index Guided Oxygen Titration in One Lung Ventilation with Low Fresh Gas Glow. Turkish Journal of Medical Sciences. 2021 May. DOI: 10.3906/sag-2009-149.
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™. 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, 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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