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.