NEWTOWN, PA — Helius Medical Technologies (NASDAQ: HSDT) has reported promising results from its Stroke Registrational Program (SRP), paving the way for a potential U.S. regulatory submission later this year. The company plans to seek FDA authorization for its Portable Neuromodulation Stimulator (PoNS) device to treat gait and balance impairments in stroke survivors under an existing Breakthrough Device Designation.
The PoNS device is a non-invasive neurostimulation system that delivers mild electrical pulses to the tongue via a mouthpiece, paired with physical rehabilitation therapy. It is currently cleared in the U.S. for gait deficits associated with multiple sclerosis (MS), but not yet for stroke-related conditions.
Helius’ latest clinical data stem from three separate studies: a double-blind, randomized controlled trial; a single-arm trial; and a pilot investigator-led study. All three focused on patients with chronic stroke symptoms. According to the company, the randomized trial met its primary endpoint, showing statistically significant improvements in gait and balance when using active PoNS therapy, both with and without supplemental data from an open-label trial. The device also demonstrated strong tolerability and a low incidence of adverse events.
A total of 159 patients were enrolled, with 130 completing both a 12-week treatment phase and a 12-week follow-up. Participants across 10 U.S. and Canadian rehabilitation centers received either active or sham PoNS therapy in combination with standard physical rehabilitation.
“The successful execution of the PoNS SRP and the positive results of the clinical trials mark an important milestone,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer. “We look forward to releasing the SRP’s study results this quarter and to continuing working closely with FDA under the upcoming application.”
CEO Dane Andreeff noted the commercial opportunity, citing that over 7 million Americans suffer from stroke-related conditions, with about 80% experiencing gait and balance deficits. “We look forward to a positive outcome of the submission to the FDA and to bringing this impactful treatment to everyone living with the consequences of a stroke,” Andreeff said.
Helius began the SRP in March 2024 after aligning with the FDA on clinical trial design and data requirements. The company intends to submit its application to the agency in the third quarter of 2025.
While PoNS is approved in Canada and Australia for multiple uses—including stroke, MS, and mild traumatic brain injury—it remains investigational for stroke rehabilitation in the United States.
If cleared by the FDA, PoNS could open a significant market for Helius, given the scale of stroke-related disabilities and the growing demand for non-invasive neurorehabilitation technologies.
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