NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jun. 8, 2016--
MASI) announced today the full market release outside the U.S. of the
Pronto® Pulse CO-Oximeter® with Next Generation
SpHb® Spot Check technology. Next Generation Pronto features
rainbow SET™ technology, for noninvasive spot checking of total
hemoglobin (SpHb), oxygen saturation (SpO2), pulse rate (PR),
and perfusion index (PI).
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Pronto Pulse CO-Oximeter with Next Generation SpHb and rainbow DCI-mini Reusable Sensor (Photo: Business Wire)
In addition to the Next Generation SpHb technology, Masimo has also
released the rainbow® DCI®-mini reusable sensor to
accompany the Pronto. The DCI-mini is a universal sensor usable on
patients greater than 3 kg, making Pronto an even more versatile
The Next Generation SpHb technology in Pronto offers motion tolerance
and a 40% reduction in time to display SpHb results. Field accuracy has
been improved in the range of 6 to 11 g/dL, and is comparable to certain
portable invasive point of care devices.
“This is a significant enhancement to the noninvasive measurement we
introduced 7 years ago,” stated Joe Kiani, Founder and CEO of Masimo.
“Since then, all of the clinical outcome studies we’re aware of on our
continuous SpHb technology have been positive,1-3 which is
something that couldn’t be said for standard pulse oximetry before the
introduction of Masimo SET SpO2. We will continue to improve
SpHb until it has the same measure-through motion and low perfusion
performance as our SET SpO2 technology.”
An upgrade program will be available for qualified existing Pronto
customers. Pronto with Next Generation SpHb and the DCI-mini reusable
sensor have not received FDA 510(k) clearance and are not currently
available for sale in the United States.
Ehrenfeld JM, Henneman JP, Bulka CM, Sandberg WS. Continuous
Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A
Randomized Trial .2014. J Blood Disorders Transf. 5:237.
Awada WN, Mohmoued MF, Radwan TM, Hussien GZ, Elkady HW. Continuous
and noninvasive hemoglobin monitoring reduces red blood cell
transfusion during neurosurgery: a prospective cohort study. J Clin
Monit Comput. 2015 Dec;29(6):733-40.
Ponsonnard S, Yonnet S, Marin B, Cros J, Ben Miled S, Nathan N.
"Continuous Hb and plethysmography variability index (PVI) monitoring
is associated to a decreased mortality at the scale of a whole
hospital." Proceedings of the European Society of Anaesthesiology's
Euroanaesthesia 2015 Annual Congress, May 30-June 2, Berlin, Germany,
16AP3-2, Room A1 – Poster Abstract Presentation Session, e-Board 8.
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 by taking noninvasive monitoring to new sites
and applications. 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® is estimated to be used
on more than 100 million patients in leading hospitals and other
healthcare settings around the world. 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®), and
more recently, Pleth Variability Index (PVI®) and 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.
Masimo is also taking an active leadership role in mHealth with products
such as the Radius-7™ wearable patient monitor and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and its
products may be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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’s Pronto® Pulse CO-Oximeter®. 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’s Pronto Pulse CO-Oximeter,
contribute to positive clinical outcomes and patient safety; risks
related to our belief that Masimo noninvasive medical breakthroughs
provide cost-effective solutions with comparable accuracy and unique
advantages, including: immediate and continuous results that enable
earlier treatment without causing invasive trauma in all patients and in
every clinical situation; 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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Irene Paigah, 858-859-7001