Helius Announces FDA 510(k) Submission for PoNS® Device Label Expansion in Stroke

Core Insights - Helius Medical Technologies has filed a 510(k) submission with the FDA for the PoNS device to expand its label for treating gait and balance deficits in chronic stroke patients [1][5] - The PoNS device has demonstrated statistically significant improvements in gait deficits compared to control groups in clinical trials [2][4] Company Overview - Helius Medical Technologies focuses on neurologic deficits using an orally applied technology platform that enhances neuroplasticity and compensatory mechanisms in the brain [8] - The company's first commercial product is the Portable Neuromodulation Stimulator (PoNS), which is designed for home use alongside physical rehabilitation [5][8] Clinical Trial Results - The PoNS device showed a mean improvement of 5.37 points in the Functional Gait Assessment (FGA) at Week 12, compared to 3.31 points in the control group, indicating statistical superiority [4] - The treatment was well tolerated, with no serious adverse events related to the PoNS device reported across the trials [4] Regulatory and Market Position - The PoNS device is already authorized for sale in Canada and Australia for various indications related to gait and balance deficits [7] - The FDA submission is seen as a significant step towards increasing patient access to the PoNS therapy for stroke rehabilitation [5]