Evie Ring's Pulse Oximeter Exceeds FDA Accuracy Guidelines in Movano Health's Second Hypoxia Trial

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Mar 14, 2024, 18:31 ET

PLEASANTON, Calif., March 14, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, has completed another hypoxia trial with the University of California, San Francisco (UCSF) yielding new blood oxygen saturation (SpO2) data, confirming the accuracy of its Evie Ring pulse oximeter exceeds the U.S. Food and Drug Administration (FDA) guidelines.

The Evie Ring entered commercial production in late 2023 as a consumer wellness device. This latest UCSF study, completed in the first quarter of 2024, used the production model ring, which reflected several design improvements from the pre-commercial model used in the earlier study and will be submitted to FDA and sold under the brand name Evie Med. During the second trial, each subject wore four Evie Rings. When testing arterial blood gas levels, the four Evie Rings achieved a root mean square error (RMSE) average of 2.46%, which was once again well below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study.

Movano Health believes one of the most critical components of the FDA submission remains the ring's clinical performance. The company plans to address the outstanding FDA comments from August 2023 for the Evie Med Ring in April 2024 and present the corroborating data from the first quarter of 2024 clinical study. Movano Health expects to receive a decision regarding its 510(k) clearance in July 2024.

"Our goal for Evie is to deliver both a consumer and medical device wearable that combines accessibility, personalization and style with the recognized capabilities of a medical device," said John Mastrototaro, CEO of Movano Health. "The results of this latest study lay the groundwork to fulfilling all aspects of that goal. The journey toward establishing ourselves as a medical device company demands considerable effort, yet we view it as a substantial competitive advantage and a valuable asset in comparison to existing wellness solutions. We look forward to continuing to work closely with the FDA throughout this final step in the review process."

The Evie Ring combines health and wellness metrics to give a full picture of one's health: resting heart rate, heart rate variability, SpO2, respiration rate, skin temperature variability, period and ovulation tracking, menstrual symptom tracking, activity profile, including steps, active minutes and calories burned, sleep stages and duration, and mood tracking. This data is delivered through a mobile app which aims to simplify how data is presented, moving away from complex graphs and charts, and turning biometric information into actionable insights that will help women make manageable lifestyle changes and take a more proactive approach to mitigating the risks of chronic disease.

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; 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.

SOURCE Movano