Movano Health announced that it successfully submitted updated pivotal clinical trial results as well as proof of enhanced medical device usability on April 22, 2024 to the U.S. Food and Drug Administration (FDA) as part of its 510(k) filing for the Company's first commercial medical device, the Evie Med Ring pulse oximeter.

An FDA clearance would bring Movano Health a significant step closer in its pursuit to disrupt the wearables industry while unlocking significant partnership opportunities. The Company continues to expect a decision regarding its 510(k) clearance in July 2024.

"From the outset, our vision has been to develop a wearable that fits with any lifestyle and is cleared by the FDA as a medical device," said John Mastrototaro, CEO of Movano Health. "The exemplary results of our latest study are a critical component of our FDA filing and lay the groundwork to fulfilling all aspects of that goal."

In January 2024, Movano Health completed a second hypoxia trial with the University of California, San Francisco (UCSF) confirming the accuracy of its Evie Med Ring pulse oximeter exceeds the U.S. Food and Drug Administration (FDA) guidelines. Notably, this accuracy applied to all skin tones on the Fitzpatrick Scale. This latest UCSF study used the production model ring, which will be sold under the brand name Evie Med, and reflected several design improvements from the pre-commercial model used in an earlier study.

During the trial, each subject wore four Evie Med Rings. The four Evie Med Rings achieved a pooled root mean square error (RMSE) of 2.46% in over 800 paired samples, which was once again well below the FDA guidance of 3.5% for SpO2. Additionally, the Evie Med Ring's accuracy exceeded that of the two commercially available, hospital-grade reference pulse oximeters in the study.

Movano Health also recently closed a USD 24 million private placement with a select group of institutional and accredited investors. As part of the transaction, the Company received a strategic seed investment from a tier-one multi-billion dollar medical device company and signed an agreement to explore future collaborations relating to development and commercialization. This strategic investment combined with the recent clinical results solidify Movano Health's edge over traditional wellness trackers, paving the way for impactful partnerships with healthcare providers and other industry leaders.

The net proceeds of the private placement are expected to be used for general corporate purposes and working capital, including accelerating the development of Movano Health's proprietary technologies and wearable medical device solutions for healthcare enterprises, including pharmaceutical, medical device and health insurers.