Masimo Announces U.S. Release Of Trace Data Visualization And Reporting Tool

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the U.S. release of Trace™, patient data visualization and reporting software designed for Masimo Root^® and Radical-7^® monitors.

Trace is the first data visualization and reporting software compatible with the full capabilities of the Masimo Root Patient Monitoring and Connectivity Platform, including Radical-7 and Radius-7^® Pulse CO-Oximeters^®, Root with integrated noninvasive blood pressure and temperature, and connected MOC-9™ modules such as SedLine^® brain function monitoring, ISA™ and ISA OR⁺ capnography, and O3^® regional oximetry.

“Trace adds a valuable and powerful visualization resource to clinical toolkits,” said Joe Kiani, Founder and CEO of Masimo. “With its unique versatility and customizability and with access to all of Masimo’s advanced measurement technologies, Trace offers clinicians the ability to review and focus on the patient data patterns that matter most for each case, in the format that provides the most insight.”

Clinicians who are interested in reviewing overnight sleep studies and who review six-minute walk patient data can benefit from Trace’s ability to rapidly generate standard oximetry reports, as well as customized oximetry reports that also include acoustic respiration rate (RRa^®) and end-tidal carbon dioxide (EtCO₂) data. Clinicians and researchers can download and evaluate patient data involving advanced rainbow SET™ parameters and capnography, SedLine, and O3 measurements. Trace can display patient data from all of these technologies on the same time axis, facilitating clinical case review. The ability to annotate and store data helps clinicians build easily accessible case histories.

Trace can communicate with Masimo devices via high-speed wired or wireless connections, with the ability to download up to 96 hours of patient data in seconds, aiding workflow efficiencies. Trace can provide analytics such as the determination of the minimum, maximum, and mean values for each measurement, the percentage of time spent at defined parameter thresholds, threshold crossing counts, and the duration of desaturation events. Visual tools such as trend graphs, histograms, and event annotations are also supported. Data can be tagged with notes, labelled with identifiers, and cropped and adjusted to allow clinicians to focus on segments and items of interest, from which a PDF report can be generated or CSV file exported.

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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. 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 help clinicians reduce severe retinopathy of prematurity in neonates,¹ improve CCHD screening in newborns,² and, when used for continuous monitoring with Masimo Patient SafetyNet™* 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,⁶ and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.⁷ 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^®), and more recently, Oxygen Reserve Index^™ (ORi™), in addition to SpO₂, pulse rate, and perfusion index (Pi). 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. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

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

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. Estimate: Masimo data on file.
7. 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 Trace™. 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 Trace, 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.