Movano Health Provides Progress Update on EvieMED Regulatory Filing
Company continues to work with FDA to bring this pioneering healthcare product to market
PLEASANTON, Calif., Aug. 5, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE) plans to meet with the FDA in mid-August, as part of the Company's ongoing process to secure a 510(k) clearance for the EvieMED Ring, a wearable designed to not only provide medical device functionality through its pulse oximetry feature, but also offer numerous wellness metrics related to sleep, activity and mood/energy/symptom logging. On April 21, 2024, Movano Health filed an updated 510(k) for the EvieMED Ring's pulse oximetry feature. At the time of the filing and based on prior interactions with the agency and its protocols, the Company indicated it could potentially receive a regulatory decision by July 2024.
Subsequent to the filing, in May and early June, two minor clarifications were requested by the FDA review team and promptly completed by Movano Health. In late June, the FDA review team requested additional information related to the wellness aspects of EvieMED. In conjunction with the Company's regulatory advisors, Movano Health provided a draft response to the FDA's questions on July 10, 2024, and requested a meeting with the agency to review the Company's draft response. Given the FDA's internal calendar, the agency has since scheduled the meeting with the Company for mid-August. Movano Health looks forward to meeting with the FDA and working towards resolving the matter related to the inclusion of EvieMED's wellness aspects in order to move forward with the review process.
"Although we understand that 510(k) regulatory review timelines can vary based on the agency's summer calendar, we remain steadfast in our commitment to the opportunity EvieMED could unlock, given the clinical evidence provided as part of the filing related to the pulse oximetry feature and our desire to work collaboratively with the agency," said John Mastrototaro, CEO and President of Movano Health.
The Company will report second quarter 2024 financial and operating results on Wednesday, August 14, 2024, after the market close. Management will host a conference call and live audio webcast to discuss these results and provide a business update on the same day at 2:00 pm PT/5:00 pm ET. Attendees can access the live webcast here or on the investors section of Movano Health's website at https://ir.movano.com.
About Movano Health
Founded in 2018, Movano Inc. (NASDAQ:MOVE) dba Movano Health, maker of the Evie Ring (www.eviering.com), 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 Ring; 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