Masimo Announces Halo ION™

IRVINE, Calif.--()--Masimo (NASDAQ: MASI) announced today that after a decade of developing and testing its comprehensive, scalable, and customizable continuous early warning score, with the aid of leading expert clinicians around the world, it is releasing Halo ION™. Halo ION allows clinicians to aggregate trend data from as few as three physiological parameters (oxygen saturation, pulse rate, and perfusion index), and as many as are available, including data from EMRs, into a single continuous early warning score. Each patient’s Halo ION score is displayed on the Masimo Patient SafetyNet™ Supplemental Remote Monitoring and Clinician Notification System as a number ranging from zero to 100, helping to streamline clinicians’ patient assessment workflow.

What is difficult for people is easy for Halo ION: in calculating scores, Halo ION not only takes advantage of immediately available patient data, but more importantly, keeps track of historical physiological data and data from other records. Halo ION thus helps to automate the process by which clinicians assess patient status over time, providing a cumulative, trended score for each patient, easily visible on the Patient SafetyNet View Stations or Replica™ mobile application, configured according to their clinical protocols, that can help facilitate their determination of a patient’s overall status. Trends in Halo ION scores, which are calculated according to how the hospital has chosen to configure Halo ION, help clinicians evaluate whether patients are improving or deteriorating according to their own criteria. Clinicians may then use this information to, for example, intervene with certain patients, to transfer or discharge certain patients, and to schedule nursing assignment loads accordingly.

Halo ION works by continuously extracting key characteristics from clinician-selected parameters that are continuously monitored on the Root® Patient Monitoring and Connectivity Hub and anything connected to Root – such as oxygen saturation (SpO2 using Masimo SET® pulse oximetry), noninvasive hemoglobin (SpHb®), blood pressure, temperature, and pulse rate – to create an overall score. Hospitals and clinicians determine which parameters to include in the overall score, how each is configured, how each is weighted, and how combinations of changes across multiple parameters affect scoring – providing the flexibility and customizability to ensure that Halo ION reflects each institution’s assessment policy.

Unlike other Early Warning Score assessment tools, which take spot-check snapshots of patient vital signs, Halo ION provides cumulative, continuous visibility into patient status over time, taking into account not only historical trend data for each parameter but also more complex characteristics, such as a parameter’s degree of stability and variability. Halo ION creates individualized, patient-specific baseline scores for each parameter – not global, one-size-fits-all thresholds – and tracks how each patient deviates from their baselines, adjusting the overall Halo ION score differently for different patients. For example, the Halo ION score might be different for two patients whose oxygen saturation drops to 89% if one patient normally has 100% SpO2 and the other 94%; those different deltas would be reflected in different amounts of change in their Halo ION scores.

Joe Kiani, Founder and CEO of Masimo, commented, “Precision medicine is no longer only about the right drug for the right patient based on their genetics, but also about individualized assessment of their state of health. Halo ION represents many years of research into how best to take the complex, almost overwhelming stream of high quality physiological data available to clinicians and present it in a way that is intuitive, efficient, and provides individualized insight into a patient’s overall status. With its unique ability to create patient-specific baselines and to take into account many subtle changes over time, Halo ION helps automate and simplify the process of patient assessment, helping clinicians stay focused on providing the best care for their 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.1 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,2 improve CCHD screening in newborns,3 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.4-6 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,7 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.8 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 patients’ 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®, 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 Iris® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://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. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  6. 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.
  7. Estimate: Masimo data on file.
  8. 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 Halo ION™. 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 Halo ION, 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; 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.

Contacts

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

Release Summary

Masimo announced the release of Halo ION™, a comprehensive, scalable, and customizable continuous early warning score.

Contacts

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