Movano Health On Track to File First FDA Submission for its Smart Ring's SpO2 and Heart Rate Data Following Successful Pivotal Hypoxia Trial

Rhea-AI Summary

Movano Health (NASDAQ: MOVE) announced promising preliminary results from its pivotal hypoxia trial, demonstrating a 2% margin of error for blood oxygen saturation (SpO₂) and a heart rate error of 2 BPM. Both metrics exceeded FDA standards, indicating high accuracy. The trial involved 11 subjects and followed an FDA-required protocol. Movano plans to file for FDA clearance in 2023. CEO John Mastrototaro emphasized the importance of developing wearable devices that empower consumers with reliable health data.

Positive

• Achieved a 2% margin of error for SpO₂, below the FDA standard of 4%.
• Heart rate error measured 2 BPM, compliant with FDA requirements.
• Successful trial involved 11 subjects and demonstrated device accuracy across varying oxygen saturation levels.
• Plans to file for FDA clearance in 2023 for its smart ring metrics.

Negative

• None.

Preliminary results demonstrated high accuracy of SpO₂ and heart rate data in its pivotal hypoxia trial, bringing the Company one step closer to developing a medical device

PLEASANTON, Calif., Dec. 14, 2022 /PRNewswire/ -- Movano Health (NASDAQ:MOVE), a purpose-driven healthcare solutions company at the intersection of medical and consumer devices, today announces successful preliminary results of its pivotal hypoxia trial, which was completed in conjunction with the University of California, San Francisco (UCSF) to assess the accuracy of its smart ring's blood oxygen saturation (SpO₂) and heart rate data. In comparing the overall accuracy of the ring's data with data from the study's reference devices, Movano Health's ring resulted in an approximate 2% margin of error, well below the FDA consensus standard of 4% for SpO₂. Additionally, the Company's device measured heart rate that had root mean square error of approximately 2 BPM, which is also in line with the FDA's requirements. Given these positive results, Movano Health expects to file for FDA clearance of these metrics in 2023.

Following a successful pilot study in July 2022, the latest study used the same protocol required by the FDA for the submission and involved 11 subjects of mixed genders and ethnicities. The participants, the majority of whom were between IV-VI, the darker skin tones on the Fitzpatrick scale, each wore a ring prototype, a Movano Health fingertip device and two reference devices. Within a controlled environment, each participant's oxygen levels were driven down to as low as 70 percent and then back up to 100 percent to test the accuracy of Movano Health's devices over the entire range of oxygen saturation including normal, mild, moderate and severe hypoxia. Movano Health device data was compared and validated by arterial blood gas data.

"Our company is deeply committed to developing wearable devices that go beyond the status quo and give all consumers, regardless of gender and ethnicity, a higher level of confidence and trust in their health data. FDA approval remains one of the top priorities for our smart ring and the outstanding preliminary results we received from our pivotal study are extremely exciting," said John Mastrototaro, CEO of Movano Health.  "Clearance of a wearable device requires extensive investment in research and development, and it has been a central goal of ours since the beginning. Providing medical-grade heart rate and SpO₂ data in the future will position us to help users better predict, prevent and understand health issues."

For more information on Movano Health, visit www.movanohealth.com. 

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, caretakers and healthcare professionals to utilize daily medical-grade data as a tool to proactively monitor and manage their health. For more information, visit www.movanohealth.com. 

UC Disclaimer
The information stated above was prepared by Movano Health and reflects solely the opinion of the corporation. Nothing in this statement shall be construed to imply any support or endorsement of Movano Health, or any of its products, by The Regents of the University of California, its officers, agents and employees.

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 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

FAQ

What were the results of Movano Health's pivotal hypoxia trial?

Movano Health reported a 2% margin of error for SpO₂ and 2 BPM for heart rate, both exceeding FDA standards.

When does Movano Health plan to file for FDA clearance?

Movano Health expects to file for FDA clearance of its smart ring's metrics in 2023.

How many subjects were involved in the Movano Health trial?

The trial involved 11 subjects with diverse genders and ethnicities.

What are the key metrics tested in Movano Health's trial?

The trial tested the accuracy of blood oxygen saturation (SpO₂) and heart rate data.

What is the significance of the trial's results for Movano Health?

The preliminary results indicate high accuracy and pave the way for regulatory approval, enhancing market potential.