Leveraging the Company's 4 x 6.7 mm
System-on-a-Chip (SoC), the clinical study results are a
significant step forward in commercializing a cuffless, radio
frequency (RF)-enabled blood pressure device
PLEASANTON, Calif., Oct. 31,
2023 /PRNewswire/ -- Movano Health (Nasdaq:
MOVE), a purpose-driven healthcare solutions company at the
intersection of medical and consumer devices and makers of the Evie
Ring, today announced the results of its Institutional Review Board
(IRB)-approved blood pressure clinical study. Movano Health's
prototype, which incorporated its SoC, demonstrated a level of
accuracy within the standards recognized by the FDA for blood
pressure monitoring devices. The Company's algorithm for blood
pressure monitoring utilized data from its prototype system
combined with the subject's demographic information and a recent
blood pressure reading.
The prototype achieved an overall mean absolute difference (MAD)
of 5.9 mmHg, which is below the 7 mmHg MAD required per a standard
for wearable, cuffless blood pressure measuring devices
(IEEE1708a-2019). The Company is also evaluating AI-based
individual calibration methods to further enhance the future
performance of the device. The 44-participant study,
conducted at the Movano Health Clinical Lab, assessed the accuracy
of its wrist-worn wearable prototype compared to a hospital-grade
FDA-cleared blood pressure monitor. The study measured the blood
pressure of each participant multiple times, including while under
stress, which resulted in an average participant systolic blood
pressure range of 25 mmHg and a total study range of 85 - 171
mmHg.
The Company's 4 x 6.7 mm SoC combines multiple antennas and a
variety of frequencies in the smallest ever RF-enabled integrated
circuit designed specifically for blood pressure and glucose
monitoring. After shrinking its multi-chip architecture from four
chips into one in mid-2022, Movano Health began using the patented
SoC in clinical studies this year, which has materially improved
the accuracy of its blood pressure measurements as seen by the
results of this most recent study. In its current form factor,
Movano Health's wearable prototype represents one of the smallest
and most accessible ways to measure blood pressure.
"After multiple iterations of optimizing our IC, antennas, and
AI algorithms, our SoC produced much cleaner signals with
significantly less noise in this study than our multiple chip
solution did previously," said Michael
Leabman, CTO and founder of Movano Health. "Most
importantly, we learned that our machine learning models hold
across a broader range of blood pressure values than in prior
studies, which is crucial for our pursuit of commercializing an FDA
cleared cuffless blood pressure wearable."
Hypertension has reached epidemic proportions in the United States and is often labeled the
silent killer as many don't know they are affected. According to
the American Heart Association, high blood pressure affects half of
Americans ages 20 years and older – or more than 122 million people
– and 59 million Americans have prehypertension. Movano
Health's cutting-edge RF technology has the potential to empower
individuals and their clinicians to better monitor and manage their
high blood pressure on a daily basis.
"Our goal is to deliver a more accurate, flexible and
cost-effective wearable blood pressure solution, and this study
reveals the initial payoff of our investment in propriety mmWave
sensor technology. We are extremely encouraged with the performance
of our SoC, and the next step is to confirm the calibration holds
in longer studies, which would open a pathway to implementing the
SoC in future iterations of the Evie Ring and other form factors,"
said John Mastrototaro, CEO of
Movano Health.
Movano Health is planning to execute a multi-week study to
determine whether periodic calibration is required and refine its
AI models on an individual patient basis beginning in the fourth
quarter of 2023. Following the completion of this longitudinal
study, the Company intends to conduct a clinical trial for its
510(k) submission to the FDA.
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, anticipated FDA clearance for the Evie Ring and other
products in development, 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