Masimo Announces FDA Clearance of the rainbow Acoustic Monitoring® RAS-45 Sensor for Infant and Neonatal Patients

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today FDA clearance of RAS-45, an acoustic respiration sensor for rainbow Acoustic Monitoring^® (RAM^®), for infant and neonatal patients. RAM could previously be used to monitor adult and pediatric patients greater than 10 kg using RAS-125c and RAS-45 sensors. With clearance of the RAS-45 sensor for infant and neonatal patients, acoustic respiration rate measurement is now, for the first time, possible for patients of all sizes, including neonates, in the United States.

RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer, the RAS-45 and RAS-125c, applied to the patient’s neck area or, for infant and neonatal patients under 10 kg, the chest. Using acoustic signal processing that leverages Masimo Signal Extraction Technology^® (SET^®), the respiratory signal is separated and processed to display continuous respiration rate (RRa^®) and an acoustic respiration waveform, a visualization of the vibrations caused by the patient’s airflow. The acoustic sensor also allows clinicians to listen to the sound of a patient’s breathing, whether at the bedside, through a point-of-care device like the Radical-7^® Pulse CO-Oximeter^®, or remotely, from a Patient SafetyNet™ view station.

The RAS-45 sensor for infant and neonatal patients offers multiple benefits of particular importance for successfully monitoring these youngest and most fragile patients. With the clearance for newborns and neonates, RRa’s accuracy range has been expanded up to 120 breaths per minute, while still providing accuracy of +/- 1 breath per minute, facilitating accurate measurement of the higher respiratory rates common in this population. The sensor itself is significantly smaller than the RAS-125c sensor, and in fact with a diameter of approximately 2.2 cm without adhesive is only slightly larger than a nickel. Similarly, it weighs so little, 13 grams, that its presence may be barely noticeable, and features an adhesive that is transparent, light, and flexible. The size, weight, and adhesive advantages make it particularly suitable for the smaller stature and delicate skin of infants and neonates.

RRa has been shown not only to be accurate^1,2 and reliable¹, but also easy-to-use¹, easy-to-tolerate^1,3, and to enhance patient compliance with respiration monitoring. In a study comparing pediatric patient tolerance of sidestream capnography with a nasal cannula to respiration rate monitoring with an RAS-125c acoustic sensor, 15 out of 40 patients removed the capnography cannula, while only one removed the RAM acoustic sensor.³ In a study of 98 patients consciously sedated during upper gastrointestinal endoscopy, researchers found that RRa monitoring with the RAS-125c sensor more accurately assessed respiration rate than impedance pneumography.²

Joe Kiani, Founder and CEO of Masimo, commented, “From the beginning, we have focused our R&D on neonates and children for many reasons, including our belief that helping clinicians care for children will provide more benefit to society. RAM harnesses the power of our breakthrough signal processing and sensor technology and applies it to a measurement that has either been unreliable or difficult to use, respiration measurement, the third vital sign.”

RAM is available on most rainbow SET™-ready platforms. Continuous monitoring of respiration rate can be helpful in cases such as sedation-based procedures and post-surgical patients receiving patient-controlled analgesia for pain management.^4,5

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

References

1. Macknet MR et al. Accuracy and Tolerance of a Novel Bioacoustic Respiratory Sensor in Pediatric Patients. Anesthesiology. 2007;107:A84 (abstract).
2. Goudra BG et al. Comparison of Acoustic Respiration Rate, Impedance Pneumography and Capnometry Monitors for Respiration Rate Accuracy and Apnea Detection during GI Endoscopy Anesthesia. Open J Anesthesiol. 2013;3:74-79.
3. Patino M et al. Accuracy of Acoustic Respiration Rate Monitoring in Pediatric Patients. Paediatr Anaesth. 2013 Sep 3.
4. Stoelting, RK et al. APSF newsletter. 2011. www.apsf.org.
5. The Joint Commission Sentinel Event Alert. Issue 49, August 8, 2012. www.jointcomission.org.

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 9 of the top 10 hospitals listed in the 2018-19 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/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

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;Jan 8;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 RAS-45, RAM^®, and RRa^®. 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 RAS-45, RAM, and RRa, 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.