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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