Preliminary results demonstrated high accuracy
of SpO2 and heart rate data in its pivotal
hypoxia trial, bringing the Company one step closer to
developing a medical device
PLEASANTON, Calif., Dec. 14,
2022 /PRNewswire/ -- Movano
Health (NASDAQ:MOVE), a purpose-driven healthcare solutions
company at the intersection of medical and consumer devices,
today announces successful preliminary results of its pivotal
hypoxia trial, which was completed in conjunction with the
University of California, San Francisco
(UCSF) to assess the accuracy of its smart ring's blood oxygen
saturation (SpO2) and heart rate data. In comparing the
overall accuracy of the ring's data with data from the study's
reference devices, Movano Health's ring resulted in an approximate
2% margin of error, well below the FDA consensus standard of 4% for
SpO2. Additionally, the Company's device measured heart
rate that had root mean square error of approximately 2 BPM, which
is also in line with the FDA's requirements. Given these positive
results, Movano Health expects to file for FDA clearance of these
metrics in 2023.
![(PRNewsfoto/Movano) (PRNewsfoto/Movano)](https://mma.prnewswire.com/media/1718078/Movano_Logo.jpg)
Following a successful pilot study in July 2022, the latest study used the same
protocol required by the FDA for the submission and involved 11
subjects of mixed genders and ethnicities. The participants, the
majority of whom were between IV-VI, the darker skin tones on the
Fitzpatrick scale, each wore a ring prototype, a Movano Health
fingertip device and two reference devices. Within a controlled
environment, each participant's oxygen levels were driven down to
as low as 70 percent and then back up to 100 percent to test the
accuracy of Movano Health's devices over the entire range of oxygen
saturation including normal, mild, moderate and severe hypoxia.
Movano Health device data was compared and validated by arterial
blood gas data.
"Our company is deeply committed to developing wearable devices
that go beyond the status quo and give all consumers,
regardless of gender and ethnicity, a higher level of confidence
and trust in their health data. FDA approval remains one of the top
priorities for our smart ring and the outstanding preliminary
results we received from our pivotal study are extremely exciting,"
said John Mastrototaro, CEO of
Movano Health. "Clearance of a wearable device requires
extensive investment in research and development, and it has been a
central goal of ours since the beginning. Providing medical-grade
heart rate and SpO2 data in the future will position us
to help users better predict, prevent and understand health
issues."
For more information on Movano Health, visit
www.movanohealth.com.
About Movano Health
Founded in 2018, Movano Inc. (NASDAQ: MOVE) dba Movano Health is
developing a suite of purpose-driven healthcare solutions to bring
medical-grade, high-quality data to the forefront of consumer
health devices. Featuring modern form factors, Movano Health's
devices capture a comprehensive picture of a person's vital health
information and uniquely translate the data into personalized and
intelligent insights that empower consumers to live healthier and
more balanced lives. Movano Health's end-to-end solutions will soon
enable consumers, caretakers and healthcare professionals to
utilize daily medical-grade data as a tool to proactively monitor
and manage their health. For more information, visit
www.movanohealth.com.
UC Disclaimer
The information stated above was
prepared by Movano Health and reflects
solely the opinion of the corporation. Nothing in this statement
shall be construed to imply any support or endorsement of
Movano Health, or any of its products, by The
Regents of the University of
California, its officers, agents and employees.
Forward Looking Statements
This press release contains
forward-looking statements concerning our expectations,
anticipations, intentions, beliefs or strategies regarding the
future. These forward-looking statements are based on assumptions
that we have made as of the date hereof and are subject to known
and unknown risks and uncertainties that could cause actual
results, conditions and events to differ materially from those
anticipated. Therefore, you should not place undue reliance on
forward-looking statements. Examples of forward-looking statements
include, among others, statements we make regarding expected future
operating results; product development and features, product
releases, clinical trial and regulatory initiatives; our
strategies, positioning and expectations for future events or
performance. Important factors that could cause actual results to
differ materially from those in the forward-looking statements are
set forth in our most recent Annual Report on Form 10-K and any
subsequent Quarterly Reports on Form 10-Q, and in our other reports
filed with the Securities and Exchange Commission, including under
the caption "Risk Factors." Any forward-looking statement in
this release speaks only as of the date of this release. We
undertake no obligation to publicly update any forward-looking
statement, whether written or oral, that may be made from time to
time, whether as a result of new information, future developments
or otherwise.
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SOURCE Movano