New Study Finds That Masimo PVi® May Be Useful in Helping ER Doctors Determine the Severity of Asthma Attacks in Pediatric Patients

Masimo (NASDAQ: MASI) today announced the findings of a retrospective study published in the American Journal of Emergency Medicine in which Dr. Gülsah Demir and colleagues at Tepecik Research and Training Hospital in Izmir, Turkey investigated the potential ability of Masimo PVi^® to guide emergency room triage decisions for pediatric patients with signs of obstructive respiratory disease, such as an asthma attack. PVi, or pleth variability index, is a noninvasive measurement of changes in perfusion index that occur during one or more respiratory cycles. The researchers concluded that “Automatic PVi measurement can be used as a noninvasive, rapid, and objective tool in the emergency department triage of patients admitted to the pediatric emergency department with signs of asthma attack or reactive respiratory tract disease.”¹

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Acute asthma attack is a common cause of admission to emergency departments (EDs) among children, and triage by severity is important for determining appropriate clinical treatment.^2,3 Noting that PVi has been shown to be an accurate method for measuring the degree of pulsus paradoxus,^4,5 a reduction in systolic blood pressure associated with obstructive respiratory tract disease, the authors sought to understand whether PVi might be of assistance to ED clinicians needing to make rapid triage decisions in such cases. They enrolled 133 patients between the ages of 2 and 18 (median age 5 years old) who arrived at the ED between May 2020 and July 2021 with a diagnosis of asthma attack or reactive respiratory tract disease. During initial examination and after treatment, patients’ PVi levels were measured using Masimo Radical-7^® Pulse CO-Oximeters^®. Severity of the asthma attack/respiratory disease was graded using the Pulmonary Index Score (PIS). Treatment decisions, including to hospitalize or to discharge, were made by clinicians who were blinded to PVi values.

The researchers found that PVi values, both before and after treatment, were significantly higher in patients with “severe” disease, compared to “mild” or “moderate” disease (p < 0.001): “Severe” patients had median PVi values of 47% (42 – 51) before treatment and 38% (32 – 44) after treatment; “moderate” patients, 31.5% (26 – 39) before and 25% (20 – 29) after; and “mild” patients, 24% (19 – 27) before and 19.5% (17 – 22) after. PVi values were also significantly higher for patients who were hospitalized, compared to those who were discharged from the ED (p < 0.001): Hospitalized patients had median PVi values of 46.5% (39 – 49) before treatment and 38% (29 – 44) after treatment; discharged patients, 26% (22 – 34) before and 21% (18 – 26) after. For all severity levels, post-treatment PVi values were significantly lower than pre-treatment values (p < 0.001). The researchers calculated a pre-treatment PVi cut-off level of 37.5% for predicting whether a patient had “severe” disease (68.75% positive predictive power, with 100% sensitivity and 85% specificity, p < 0.001) and would require hospitalization (72.34% positive predictive power, with 91.89% sensitivity and 71.74% specificity, p < 0.001).

The authors concluded, “The severity of attacks of many patients who apply to the pediatric emergency department because of an attack due to obstructive respiratory tract diseases can be accurately defined with certain clinical evaluation tools. Although PIS is a very important tool for assessing attack severity, it includes some subjective parameters. Automatic PVi measurement can be useful in intensive emergency department conditions, especially in triage, in terms of predicting the response of patients to treatment and follow-up results by quickly determining the severity of attacks, and in terms of reducing subjective clinical decision variations among physicians. This is because it provides objective data.”

In the U.S., PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

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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 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.⁶ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁷ improve CCHD screening in newborns,⁸ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^9-12 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹³ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.¹⁴ 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^®. In 2022, Masimo acquired Sound United, a leading developer of premium consumer sound and home integration technologies, whose brand include Bowers & Wilkins^®, Denon^®, Polk Audio^®, Marantz^®, Definitive Technology^®, Classé^®, and Boston Acoustics^®. 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. Demir G, Berksoy E, Bardak S, Elibol P, Çiçek A, Özon A, Nalbant T, Gölkap G. Use of the pleth variability index in children with obstructive respiratory disease. Amer J Emerg Med. 11 Mar 2022. DOI: https://doi.org/10.1016/j.ajem.2022.03.019.
2. Network, B.T.S.S.I.G. British guideline on the management of asthma [Internet]. 2016 [cited 2019 June 26]. Available from: https://www.brit-thoracic.org.uk/qualityimprovement/guidelines/asthma/
3. Reddel HK, Bateman ED, Becker A, Boulet LP, Cruz AA, Drazen JM, et al. A summary of the new GINA strategy: a roadmap to asthma control. Eur Respir J. 2015;46(3):622‐39.doi: 10.1183/13993003.00853-2015.
4. G Krishnan S, Wong HC, Ganapathy S, Ong GY. Oximetry-detected pulsus paradoxus predicts for severity in paediatric asthma. Arch Dis Child. 2020 Jun;105(6):533-38. doi: 10.1136/archdischild-2019-318043.
5. Brandwein A, Patel K, Kline M, Silver P, Gangadharan S. Using pleth variability as a triage tool for children with obstructive airway disease in a pediatric emergency department. Pediatr Emerg Care. 2018;34(10):702-5. doi: 10.1097/PEC.0000000000000887.
6. 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.
7. 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.
8. 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.
9. 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.
10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
11. 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.
12. 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.
13. Estimate: Masimo data on file.
14. 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 PVi^®. 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 technologies, including PVi, 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