PLEASANTON, Calif., March 14,
2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a
pioneer in health technology, has completed another hypoxia
trial with the University of California, San
Francisco (UCSF) yielding new blood oxygen saturation (SpO2)
data, confirming the accuracy of its Evie Ring pulse oximeter
exceeds the U.S. Food and Drug Administration (FDA) guidelines.
The Evie Ring entered commercial production in late 2023 as a
consumer wellness device. This latest UCSF study, completed in the
first quarter of 2024, used the production model ring, which
reflected several design improvements from the pre-commercial model
used in the earlier study and will be submitted to FDA and sold
under the brand name Evie Med. During the second trial, each
subject wore four Evie Rings. When
testing arterial blood gas levels, the four Evie Rings achieved a root mean square error
(RMSE) average of 2.46%, which was once again well below the FDA
guidance of 3.5% for SpO2. Additionally, the Evie Ring's accuracy
exceeded that of the two commercially available, hospital-grade
reference pulse oximeters in the study.
Movano Health believes one of the most critical components of
the FDA submission remains the ring's clinical performance. The
company plans to address the outstanding FDA comments from
August 2023 for the Evie Med Ring in
April 2024 and present the
corroborating data from the first quarter of 2024 clinical study.
Movano Health expects to receive a decision regarding its 510(k)
clearance in July 2024.
"Our goal for Evie is to deliver both a consumer and medical
device wearable that combines accessibility, personalization and
style with the recognized capabilities of a medical device," said
John Mastrototaro, CEO of Movano
Health. "The results of this latest study lay the groundwork to
fulfilling all aspects of that goal. The journey toward
establishing ourselves as a medical device company demands
considerable effort, yet we view it as a substantial competitive
advantage and a valuable asset in comparison to existing wellness
solutions. We look forward to continuing to work closely with the
FDA throughout this final step in the review process."
The Evie Ring combines health and wellness metrics to give a
full picture of one's health: resting heart rate, heart rate
variability, SpO2, respiration rate, skin temperature variability,
period and ovulation tracking, menstrual symptom tracking, activity
profile, including steps, active minutes and calories burned, sleep
stages and duration, and mood tracking. This data is delivered
through a mobile app which aims to simplify how data is presented,
moving away from complex graphs and charts, and turning biometric
information into actionable insights that will help women make
manageable lifestyle changes and take a more proactive approach to
mitigating the risks of chronic disease.
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 and their healthcare professionals to utilize
daily medical-grade data as a tool to proactively monitor and
manage health outcomes. For more information on Movano Health,
visit https://movanohealth.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 plans with respect to commercial launch of the Evie
Ring; planned cost-cutting initiatives; anticipated FDA clearance
for the Evie Ring and other products in development; expected
future operating results; product development and features, product
releases, clinical trials 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