Masimo Announces the Addition of Early Warning Score to the Root® Patient Monitoring and Connectivity Platform

Masimo (NASDAQ: MASI) announced today the limited market release of Early Warning Score (EWS) on the Root^® patient monitoring and connectivity platform. EWS aggregates information from multiple vital signs and clinical observations to generate a score that represents the potential degree of patient deterioration.

Root, which works in conjunction with Radical-7^® or Radius-7^® Pulse CO-Oximeters^® and Masimo Open Connect™ (MOC-9™) measurements, features Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, rainbow SET™ pulse CO-Oximetry, Nomoline™ capnography and gas monitoring, SedLine^® brain function monitoring, O3™ regional oximetry, and SunTech^® blood pressure and Welch Allyn^® temperature monitoring. Masimo SET^® helps clinicians monitor oxygen saturation and pulse rate during motion and low perfusion for more than 100 million patients a year¹ and is the primary pulse oximetry technology at top hospitals, including 9 of the top 10 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.²

Patient data from Radical-7 or Radius-7 and data collected using Root and other connected Masimo and third-party devices can be shared with Masimo Patient SafetyNet™*, providing hospital-wide remote monitoring and clinician notification, as well as the ability to automatically push patient data to a hospital’s Electronic Medical Record (EMR). Each time a clinician pushes data to the EMR via Root connected to Patient SafetyNet, an Early Warning Score (EWS) can now be included. Clinicians can also choose to have the standalone Root perform EWS calculations.

There are several EWS protocols, such as Pediatric Early Warning Score (PEWS), Modified Early Warning Score (MEWS), and National Early Warning Score (NEWS). These various scores require vital signs contributors – such as oxygen saturation, pulse rate, respiration rate, body temperature, and systolic blood pressure – and contributors input by clinicians, such as level of consciousness, use of supplemental oxygen, and urine output. The weighting and number of contributors differ depending upon which EWS protocol is used. Root can be customized for various predefined EWS protocols, or hospitals can configure their own set of required contributors, and their relative weights, to create an EWS unique to their care environment.

Recent peer-reviewed studies, across care areas, have suggested that the use of NEWS may have clinical benefits: Vanamali et al. notes that NEWS is a “useful simple physiological scoring system for assessment and risk management of medical emergency admissions.”³ Smith et al. found that an EWS of 5 or greater after laparotomy is associated with adverse outcomes, while recommending that future studies evaluate the ability of EWS to predict and prevent such outcomes.⁴

Outside the U.S., as part of the Patient SafetyNet platform, Masimo also offers Halo Index™. Whereas EWS provides a spot-check score using the NEWS standard, Halo Index presents a dynamic, cumulative trending assessment of global patient status as a single displayed number ranging from 0 to 100. Halo Index uses available Masimo parameters from connected monitoring devices, but is scalable to include additional information from the patient data repository. Masimo designed Halo Index to mimic the systematic approach that expert clinicians use in assessing patient physiologic deterioration, analyzing the patient’s history and extracting key vital sign parameter characteristics; increases in a patient’s Halo Index may indicate the need for clinicians to more closely assess the patient.

“Root, from its versatile connectivity options to its advanced patient monitoring, from rainbow^® SpHb^® to SET^® SpO₂, has long been helping hospitals improve and automate their patient care. Now, with Early Warning Score, Root can help clinicians stay ahead of the care race and transfer their patient home safely,” said Joe Kiani, Founder and CEO of Masimo.

Root with Early Warning Score (EWS) and Halo Index are not available in the U.S. EWS is a convenient aid to clinical assessment and not a substitute for clinical judgment.

@MasimoInnovates | #Masimo

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

1. Estimate: Masimo data on file.
2. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview Taenzer AH 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.
3. Vanamali DR, et al. The Role of National Early Warning Score (News) in Medical Emergency-Patients in Indian Scenario: A Prospective Observational Study. Journal of Evolution of Medical and Dental Sciences. 2014; Vol. 3, Issue 13, March 31; Page: 3524-3528, DOI: 10.14260/jemds/2014/2315.
4. Smith, et al. Early warning score: An indicator of adverse outcomes in postoperative patients on a gynecologic oncology service. Gynecol Oncol. 2016 Oct; 143(1):105-8. doi: 10.1016/j.ygyno.2016.08.153. Epub 2016 Aug 6.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET^® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.^3,4,5 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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^®), and more recently, Pleth Variability Index (PVi^®) and Oxygen Reserve Index (ORi™), in addition to SpO₂, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion^*,6,7 and when used with PVi, reductions in length of hospital stay⁸ and 30- and 90-day mortality.⁹ In 2014, Masimo introduced Root^®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO₂ ^® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

References

1. 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.
2. 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;338.
3. Taenzer AH 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. McGrath SP 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.
6. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
7. Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.
8. Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
9. Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring. Proceedings from the 2016 ASA Annual Meeting, Chicago. Abstract #A1103.

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 Root^®. 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 Root, contribute to positive clinical outcomes and patient safety; 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

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