Company's first 510(k) clearance unlocks a TAM
of $40 billion in healthcare B2B
opportunities
PLEASANTON, Calif., Dec. 2, 2024
/PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer
in health technology, today announced U.S. Food and Drug
Administration (FDA) 510(k) clearance for the pulse oximeter in its
EvieMED Ring. The clearance enables Movano Health to pursue
multi-billion dollar business opportunities for health monitoring
solutions needed for applications such as clinical trials,
post-clinical trial management, and remote patient monitoring for
both healthcare providers and payors.
Movano Health Receives FDA Clearance for
EvieMED Ring
"We launched the Evie Ring in the consumer wearable market, but
our broader goal has always been to provide a clinical-grade device
for B2B channels," said John
Mastrototaro, President and CEO of Movano Health. "This FDA
510(k) clearance marks a major milestone for the Company and
expands our reach to pharmaceutical companies, medical device
manufacturers and payors looking for a more accurate, consistent
and comfortable health monitoring solution that would help improve
compliance by fitting easily into patient lifestyles."
In anticipation of an expected 510(k) clearance, Movano Health
has been collaborating with a number of potential partners
operating across the entire healthcare industry spectrum and
expects its partner pipeline to expand further following the news
of a clearance. The Company is currently in the agreement phase
with a large payor for a pilot study with the EvieMED Ring planned
for early 2025 related to the health management of high-risk
populations and is also in discussions with a global pharmaceutical
company and leading clinical research organization (CRO) to use the
EvieMED Ring in upcoming clinical trials. In addition, the EvieMED
Ring was recently selected for a groundbreaking MIT study on long COVID and chronic Lyme
disease.
"This milestone marks the beginning of our plans to accelerate
distribution of EvieMED. With the significant foundational work in
achieving our first clearance now behind us, we are eager to
continue to collaborate with the FDA on securing additional
clearances including respiration rate and other critical analytes
and diagnoses," continued Mastrototaro. "We also remain excited
about the opportunities to leverage our proprietary radio frequency
(RF) technology to address cuffless blood pressure and noninvasive
glucose monitoring."
Pulse oximeters measure blood oxygen (SpO2) levels
and heart rate, but conventional solutions have significant
shortcomings and can be uncomfortable, discouraging compliance that
is needed to ensure reliable information for evaluating a patient's
health. The EvieMED Ring eliminates those limitations by combining
the accuracy of a medical device with the comfort of a wearable
that can be worn continuously, thanks in part to an award-winning
design with a small gap in the ring surface and slight flex that
accommodates finger swelling. A pivotal study also found that the
EvieMED Ring produces accurate readings among users with darker
skin tones as measured by the Fitzpatrick scale of skin color
classification.
In addition, the EvieMED Ring collects wellness metrics
including sleep, activity, temperature variability, calories burned
and respiration rate that can give both patients and healthcare
providers a broader picture of the user's overall wellness.
The EvieMED Ring will be available in eight sizes ranging from 5
to 12 to accommodate the widest selection of patients.
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 plans with
respect to the commercial launches of the Evie Ring and EvieMED;
our expectations regarding potential commercial opportunities;
planned cost-cutting initiatives; anticipated FDA clearance
decisions with respect to our products; 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