Unlocking business-to-business opportunities
with Evie Med, Movano Health's ring pulse oximeter, remains a key
priority for the Company.
PLEASANTON, Calif., May 9, 2024
/PRNewswire/ -- Movano Health (Nasdaq: MOVE)
announced that it successfully submitted updated pivotal clinical
trial results as well as proof of enhanced medical device usability
on April 22, 2024 to the U.S. Food
and Drug Administration (FDA) as part of its 510(k) filing for the
Company's first commercial medical device, the Evie Med Ring pulse
oximeter. An FDA clearance would bring Movano Health a significant
step closer in its pursuit to disrupt the wearables industry while
unlocking significant partnership opportunities. The Company
continues to expect a decision regarding its 510(k) clearance
in July 2024.
"From the outset, our vision has been to develop a wearable that
fits with any lifestyle and is cleared by the FDA as a medical
device," said John Mastrototaro, CEO
of Movano Health. "The exemplary results of our latest study are a
critical component of our FDA filing and lay the groundwork to
fulfilling all aspects of that goal."
In January 2024, Movano Health
completed a second hypoxia trial with the University of
California, San
Francisco (UCSF) confirming the accuracy of its Evie Med
Ring pulse oximeter exceeds the U.S. Food and Drug
Administration (FDA) guidelines. Notably, this accuracy
applied to all skin tones on the Fitzpatrick Scale. This latest
UCSF study used the production model ring, which will be sold under
the brand name Evie Med, and reflected several design improvements
from the pre-commercial model used in an earlier study.
During the trial, each subject wore four Evie Med Rings. The
four Evie Med Rings achieved a pooled root mean square error (RMSE)
of 2.46% in over 800 paired samples, which was once again well
below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Med
Ring's accuracy exceeded that of the two commercially available,
hospital-grade reference pulse oximeters in the study.
Movano Health also recently closed a $24
million private placement with a select group of
institutional and accredited investors. As part of the transaction,
the Company received a strategic seed investment from a tier-one
multi-billion dollar medical device company and signed an agreement
to explore future collaborations relating to development and
commercialization. This strategic investment combined with the
recent clinical results solidify Movano Health's edge over
traditional wellness trackers, paving the way for impactful
partnerships with healthcare providers and other industry
leaders.
The net proceeds of the private placement are expected
to be used for general corporate purposes and working capital,
including accelerating the development of Movano Health's
proprietary technologies and wearable medical device solutions for
healthcare enterprises, including pharmaceutical, medical device
and health insurers.
About The Evie Med Ring
The Evie Med Ring combines medical device and wellness metrics
to give a full picture of one's health. In addition to pulse
oximeter medical data (SpO2 and pulse), these wellness metrics will
be provided:
- Activity: log a workout, active minutes, steps, distance
traveled, heart rate, and calories burned
- Sleep: start time, stop time, duration, and cycles (awake,
light, deep, and rapid eye movement (REM)), resting heart rate
average, oxygenation maximum, heart rate variability, respiration
rate, skin temperature variability average)
- Women's health tracking: menstrual cycle and ovulation, mood,
energy, and symptom tracking
- Goal setting (sleep, active minutes, steps, mood and symptoms,
workout sessions)
- Daily Summary graphic (activity, calories, steps, and sleep,
mood and energy logging)
This data is delivered through a companion mobile app which aims
to simplify how data is presented, moving away from complex graphs
and charts, and turning biometric data into actionable insights
that will help consumers make manageable lifestyle changes and
patients and their health care providers to take a more proactive
approach to managing and treating chronic disease in healthcare and
home environments.
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 data to
the forefront of wearables. Featuring modern and flexible form
factors, Movano Health's devices offer an innovative approach to
delivering trusted data to both customers and enterprises,
capturing a comprehensive picture of an individual's health data
and uniquely translating it into personalized and intelligent
insights.
Movano Health's proprietary technologies and wearable medical
device solutions will soon enable the use of data as a tool to
proactively monitor and manage health outcomes across a number of
patient populations that exist in healthcare. 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 the closing of
the private placement transaction; 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