MASIMO

Masimo (NASDAQ: MASI) today announced the findings of a before-and-after study published in PLoS ONE in which Dr. Ahmed Balshi and colleagues at King Saud Medical City in Riyadh, Saudi Arabia, evaluated the impact of implementing remote patient monitoring with Masimo Patient SafetyNet™ on the efficacy of hospital rapid response teams (RRTs). Comparing outcomes before and after implementation of Patient SafetyNet, they found that the “after” group experienced more RRT activations but had significantly lower incidence and rate of cardiopulmonary resuscitation (CPR), significantly shorter hospital length of stay (LOS), and lower hospital mortality.¹

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Noting that RRT activation depends on the “timely detection of [patient] deterioration,” the researchers sought to determine whether a remote patient surveillance system that automated calculation and relaying of early warning scores could lead to earlier recognition of changes in patient status and the improved efficacy of RRTs. They hypothesized that implementing such a system could decrease the rate of severe adverse events, as a result of potentially quicker RRT activation. To that end, they designed a “before” and “after” study at a large government hospital (1,200 inpatient beds) in central Saudi Arabia where the ICU provides outreach, in the form of an RRT, to the general ward.

In the “before” period (retrospective data) nurses manually recorded patient vital signs, calculated warning scores, and activated RRTs; in the “after” period” (prospective data), vital signs data collected at the bedside, alongside automatically calculated warning scores, were wirelessly relayed to nursing stations for centralized remote patient surveillance and RRT activation. Both before and after, activation of an RRT was triggered when a patient’s vital signs deteriorated to the point they scored ≥ 5 on the MEWS (Modified Early Warning Score) scale. “Before” group data was analyzed from 2,346 adult patients from January to August 2020, and “after” group data from 2,151 patients from September 2020 to April 2021. For the “after” group, Masimo Patient SafetyNet was used to automate transfer of bedside monitoring data to central nursing stations, with alarm and notification data also relayed to clinicians’ smartphones using Masimo Replica^®.

The researchers found that in the “before” group, there were 78 episodes of CPR over 20,510 total inpatient days, for an incidence of 3.3% and rate of 3.8 per 1000 inpatient days (95% confidence interval: 3 – 4.7 episodes). In the “after” group, there were 42 episodes over 17,945 inpatient days, for an incidence of 1.95% and rate of 2.3 per 1000 inpatient days (95% CI: 1.7 – 3.2). CPR incidence in the “after” group was significantly lower (p = 0.01). In addition, the CPR success rate was significantly higher in the “after” group (before: 38.5% vs. after: 59.5%; p = 0.04). The average hospital LOS was higher in the “before” group (before: 8.7 days ± 3.4 days vs. after: 8.3 days ± 3 days; 95% CI of the difference: 0.2 – 0.6 days; p < 0.001). The number of RRT activations was lower in the “before” group (before: 20 ± 7 vs. after: 23.7 ± 9.4; 95% CI of the difference: 3.2 – 4.2; p < 0.001). Overall hospital mortality was lower in the “after” group (before: 5.45% vs. after: 4%; 95% CI: 0.6 - 2.2; p < 0.001). Using multivariable logistic regression, they calculated that being in the “after” group decreased a patient’s odds of needing CPR by 33% (odds ratio: 0.67; 95% CI: 0.46 – 0.99; p = 0.04).

The investigators concluded, “Automated activation of the RRT by Masimo Patient SafetyNet applied to medical ward patients significantly reduced CPR events and rates, reduced hospital length of stay, and increased the number of RRT activations. There was no difference in the ICU admission rates. Further evaluation of the system in surgical wards and mixed settings [should be] conducted.”

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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. Balhi AN, Al-Odat MA, Alharthy AM, Alshaya RA, Alenzi HM, Dambung AS, Mhawish H, Altamimi SM, Aletreby WT. Tele-Rapid Response Team (Tele-RRT): The effect of implementing patient safety network system on outcomes of medical patients—A before and after cohort study. PLoS ONE. 17(11):e0277992. https://doi.org/10.1371/journal.pone.0277992.
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 Patient SafetyNet™ and Replica^® 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 Patient SafetyNet and Replica, 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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