Helius Medical Technologies, Inc. (NASDAQ: HSDT) announced today, September 26, 2025, that it has filed a U.S. Food and Drug Administration (FDA) 510(k) submission to expand the label of its Portable Neuromodulation Stimulator (PoNS) for patients with chronic stroke who experience gait and balance deficits.
The submission is based on data from the company’s Stroke Registrational Program (SRP), which enrolled 159 chronic stroke survivors across 10 sites. The primary endpoint, the Functional Gait Assessment (FGA), showed a mean improvement of 5.37 points in the PoNS plus physical therapy group versus 3.31 points in the sham control group, a statistically significant difference (p < 0.05). Durability of the effect was demonstrated at 12 weeks post‑treatment, with 89.7% of subjects maintaining the improvement.
By obtaining FDA clearance for this indication, PoNS would gain access to a large stroke market and could be reimbursed under Medicare and commercial payers, potentially generating significant new revenue streams for Helius. The filing is made under the company’s existing Breakthrough Device designation, underscoring the therapeutic importance of the data and the company’s confidence in a favorable regulatory outcome.
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