Vital health metric demonstrates wearable's
potential to properly track heart health and detect possible
illnesses
PLEASANTON, Calif., Aug. 9, 2022
/PRNewswire/ -- Movano Inc. (NASDAQ: MOVE), a purpose-driven
healthcare solutions company at the intersection of medtech and
consumer devices, announces today the successful completion
of a study with the University of California
San Francisco (UCSF) to assess the accuracy of the Movano
Ring's blood oxygen saturation (SpO2) and heart rate
data. With results that exceeded the requirements of the industry
standard used by FDA for evaluating SpO2 devices, this
successful study is a promising step toward the company's goal to
provide medically-validated data to consumers and healthcare
professionals.
The study was conducted on seven subjects of mixed genders and
ethnicities and followed the same protocol that we expect will be
required by the FDA for the submission. Wearing a Movano Ring
prototype and 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's device during mild, moderate and severe hypoxia. The
prototype also measured heart rate during this time and
participants' heart rate varied from 60 to 120 beats per minute as
they were being deprived of oxygen.
In comparing the overall accuracy of the Ring's data with that
of the reference devices, the Movano Ring resulted in a 2% margin
of error, well below the FDA's 4% requirement for SpO2.
In addition, the Ring also estimated heart rate with accuracy
commensurate with the FDA's standards.
As Movano eyes its first FDA submission, validating the device's
ability to measure blood oxygen levels, heart rate and other vitals
is a top priority for the company. Based on the positive results
from this study, Movano plans to conduct a larger pivotal study for
the FDA submission later this year.
"The FDA has a high threshold for accuracy and requires an
extensive investment by any company to prepare to meet these
standards. This hypoxia study is a promising display of the quality
metrics our ring can deliver," said John
Mastrototaro, CEO of Movano. "While this outcome is an
exciting step toward the FDA submission, what it really means for
consumers and healthcare providers is we're one step closer to
being able to trust and utilize the ring data in a meaningful
way."
For more information on Movano and the Movano Ring, visit
www.movano.com.
About Movano
Founded in 2018, Movano Inc.
(NASDAQ:MOVE) 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's wearables 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's end-to-end
solutions will soon enable a world where consumers, caretakers and
healthcare professionals can utilize daily health data as a tool to
proactively monitor and manage their health. For more information,
visit www.movano.com.
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