Study Investigates the Ability of Masimo O3® to Aid in Monitoring Septic Shock ICU Patients and Predicting Mortality

(BUSINESS WIRE) -- Masimo (NASDAQ: MASI) announced today the findings of a study published in the Journal of Anesthesia & Clinical Research in which Dr. Debdipta Das and colleagues at Medical College Kolkata in India evaluated the utility of Masimo O3^® Regional Oximetry to aid in monitoring septic shock patients admitted to the ICU.¹ O3, available on the Masimo Root^® Patient Monitoring and Connectivity Platform, uses noninvasive near-infrared spectroscopy (NIRS) to enable monitoring of regional oxygen saturation (rSO₂) in the region of interest, such as the brain or cerebral tissue (CrSO₂). The researchers found that O3 trends correlated significantly with a variety of other hemodynamic variables and lactic acid levels commonly used in the monitoring of septic shock patients. They also found rSO₂ values differed significantly between patients who survived and those who did not, suggesting it may have value as a predictor of mortality in septic shock patients.

Noting the value of assessing tissue perfusion to aid in the management of hemodynamically challenged ICU patients, the researchers sought to evaluate whether noninvasive cerebral regional oxygen saturation monitoring might prove a viable adjunct or alternative to methods that may be affected by the patient’s baseline condition (such as vital signs monitoring) and invasive methods (like blood lactate measurement), which carry a host of limitations (intermittent and delayed measurement, blood loss, etc.). To do so, they monitored 40 adult patients, diagnosed with septic shock and admitted to the Critical Care Unit, with Masimo O3 and a variety of other measurements every six hours for 72 hours after admission.

The researchers found that O3 cerebral oxygenation trends correlated significantly with other parameters commonly used in monitoring septic shock patients. There was a significant negative correlation between cerebral rSO₂ and lactic acid (r = -0.749 to -0.956) after the first six hours after admission. They also found significant positive correlations between cerebral rSO₂ and central venous saturation (r = 0.904 to 0.993), mean arterial pressure (r = 0.957 to 0.993), and arterial oxygen saturation (r = 0.864 to 0.988).

Notably, the researchers found that survivors (n = 29) had a significant difference in cerebral rSO₂ over the 72 hours after admission compared to non-survivors (n = 11) (p < 0.001), suggesting that O3 rSO₂ measured on cerebral tissue may have predictive value for mortality in septic shock patients.

As part of the study, patients with cerebrovascular stroke, cerebral infarction, cerebral hemorrhage, convulsions, or paresis, as well as patients with a more than 10% difference in rSO₂ values between the two sides of the brain, were excluded.

The researchers concluded that Masimo O3 rSO₂ on cerebral tissue “could be [a] parameter in patients with shock and it could have a prognostic value in mortality prediction and clinical outcome.” They elaborated, “In the current study, we highlight other new advantages of NIRS monitoring in circulatory shock (septic) as a continuous monitor and as an outcome predictor. The most important observation from this study is the significant correlation between NIRS oximetry readings and hemodynamic variables, especially lactic acid [and] central venous oxygen saturation in patients experiencing shock. These data, therefore, propose a method for rapid and noninvasive assessment of circulatory status in patients experiencing shock.”

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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. Das D, Mitra K, Das S. Brain CO-Oximetry: A Useful Noninvasive Parameter Adjuvant to Standard Perfusion Parameters in Septic Shock. J Anesth Clin Res. 12(1)987.

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 O3^®. 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 O3, 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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