Market Overview

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

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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.

This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180910005179/en/

Masimo Root® with Radical-7®, RRa®, and the RAS-45 Infant/Neonatal Sensor (Photo: Business Wire)

Masimo Root® with Radical-7®, RRa®, and the RAS-45 Infant/Neonatal Sensor (Photo: Business Wire)

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 accurate1,2 and reliable1,
but also easy-to-use1, easy-to-tolerate1,3, 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

@MasimoInnovates |
#Masimo

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.

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