Helius Medical announces FDA 510k submission for PoNS device label expansion

Helius Medical (HSDT) Technologies announced the filing of its U.S. Food and Drug Administration, FDA, 510(k) submission for the PoNS device label expansion seeking an indication for gait and balance deficit in patients with chronic stroke symptoms. The submission was made with data generated in its Stroke Registrational Program, SRP, and was filed under its current FDA Breakthrough Device Designation. All statistical analyses for the Functional Gait Assessment, FGA, primary endpoint demonstrated PoNS superior effectiveness in improving gait deficit by achieving a clinically meaningful mean improvement of more than 5 points, which was statistically significant across all studies and was maintained for at least 12 weeks after completion of the therapy. Conversely the control group achieved, across all trials, a mean FGA improvement of less than 4 points, which fell below the 4.2-point Minimal Detectable Change that reflects clinical meaningfulness of the therapeutic