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Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine® Brain Function Monitoring

MASI | March 4, 2019

Masimo Announces CE Marking of Pediatric Indication for Next Generation SedLine^® Brain Function Monitoring

Next Generation SedLine Now Available for Use on Patients 1-18 Years Old in CE Mark Countries

Masimo (NASDAQ: MASI) announced today the CE marking of Next Generation SedLine^® brain function monitoring for pediatric patients (1-18 years of age). With this clearance, the benefits of Next Generation SedLine are available for all patients one year old and above in CE mark countries. SedLine helps clinicians monitor the state of the brain under anesthesia with bilateral data acquisition and processing of four leads of electroencephalogram (EEG) signals.

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Masimo Root® with Next Generation SedLine® (Photo: Business Wire)

SedLine uses a pediatric-specific signal processing engine to improve performance of Masimo’s processed EEG parameter, the Patient State Index (PSi), when monitoring pediatric patients one year old and above. The use and monitoring of anesthesia on pediatric patients can differ from its use on adults.^1-2 Maintaining an appropriate level of anesthesia is key to preventing anesthesia-related events and enabling faster recovery.³ The PSi in SedLine, driven by its pediatric-specific engine, is uniquely suited to helping clinicians interpret the EEGs of this challenging population.

In addition to the newly announced pediatric-specific signal processing when used on pediatric patients, Next Generation SedLine offers significant improvements over original SedLine, including:

A PSi with less susceptibility to electromyography (EMG) interference.
A Multitaper Density Spectral Array (DSA), which may enhance visibility of EEG features.

Joe Kiani, Founder and CEO of Masimo, said, “Next Generation SedLine is doing for brain function monitoring what Masimo SET^® did for pulse oximetry. We believe Next Generation SedLine is the best and most advanced way to monitor depth of sedation, crucial to helping ensure patients with even the most challenging brains are appropriately anesthetized. We are gratified that its benefits are now available to those younger patients whose brains are particularly delicate and to whose wellbeing Masimo has always been so committed.”

Next Generation SedLine has received FDA clearance for adults but is not currently indicated for pediatric patients in the USA.

@MasimoInnovates | #Masimo

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 over 100 independent and objective studies to outperform other pulse oximetry technologies.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.^7-9 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,¹⁰ 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.¹¹ 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/evidence/featured-studies/feature/.

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

Davidson et. Current Anesthesiology Reports 3. 1 (2013): 57-63.).
Cornelissen L et al. Elife 4 (2015): e06513.
Musialowicz et al. Current Anesthesiology Reports 4. 3 (2014): 251-260.
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
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.
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.
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.
Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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.
Estimate: Masimo data on file.
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 SedLine^® and Next Generation SedLine. 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 SedLine and Next Generation SedLine, 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.