Movano Health (MOVE) said Thursday that it has completed another hypoxia trial with the University of California, San Francisco or UCSF yielding new blood oxygen saturation data, confirming the accuracy of its Evie Ring pulse oximeter exceeds the U.S. Food and Drug Administration guidelines.
MOVE closed Thursday's regular trading at $0.50 down $0.03 or 4.90%. But in the after-hours trading, the stock gained $0.06 or 12.27%.
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 the new blood oxygen saturation. 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.
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