Helius Medical Technologies Advances Stroke Rehabilitation with Positive PoNS Phase 3 Results

July 21, 2025

DENVER, Colo., Jul 21, 2025 (247marketnews.com)- Helius (NASDAQ:HSDT) reported positive results from its PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP). These results support the company’s planned submission, in the third quarter of 2025, to the U.S. Food and Drug Administration (FDA) for a new indication targeting gait and balance deficits in patients with chronic stroke symptoms. The submission will proceed under Helius’ current Breakthrough Device Designation.

Key primary outcomes from the SRP include:

  • A double-blind, randomized clinical trial met its primary endpoint by demonstrating statistically significant improvements in stroke-related gait and/or balance deficits in patients treated with active PoNS Therapy. These results held both with and without the inclusion of data from an open-label study, which utilized statistical methods to balance baseline characteristics.
  • The studies also showed a low incidence of adverse events and good treatment tolerability.

Antonella Favit-Van Pelt, M.D., Ph.D., Chief Medical Officer of Helius, stated, “The successful execution of the PoNS SRP and the positive results of the clinical trials mark an important milestone in advancing the standard of care for stroke and offer individuals suffering from gait/balance disability a meaningful therapeutic option to rehabilitate and regain their functionality.”

The SRP launched in March 2024 following a constructive dialogue with the FDA regarding the data development strategy, study design, and endpoints. It includes two pivotal Sponsor-initiated studies: a double-blind, randomized controlled trial and a single-arm trial, both initiated in April 2024. Additionally, the program is supported by an investigator-initiated pilot trial led by Dr. Steve Kautz and Dr. Mark Bowden of MUSC (SC) and Brooks Rehabilitation (FL), which began in late 2023. All three trials enrolled from a consistent patient population and followed a unified protocol focused on evaluating the efficacy and safety of PoNS for individuals with gait impairments resulting from chronic stroke.

Across the three studies, a total of 159 patients were enrolled. Of these, 130 patients completed both the 12-week treatment period and the 12-week follow-up phase. Treatments were administered across 10 clinical sites, including leading stroke rehabilitation centers in the U.S. and Canada. Participants received either active or sham therapy, in combination with physical therapy consistent with current rehabilitation guidelines for chronic stroke.

Primary endpoints for all three trials centered on improvement in gait and/or balance after 12 weeks of treatment. Two key secondary endpoints, evaluating fall risk and durability of effect over 12 weeks, were also assessed under multiplicity control. The double-blind, randomized trial achieved its primary goal, with statistical significance shown for the active PoNS therapy in improving stroke-related deficits. Across all studies, results showed a minimal rate of adverse events and confirmed the therapy’s tolerability.

Dane Andreeff, CEO of Helius, added, “More than 7 million patients suffer from the symptoms of stroke and about 80% of them have balance and gait deficit, resulting in a large addressable market with a high risk of falling. 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.”

PoNS is not yet approved for stroke rehabilitation in the United States and remains investigational for this use. Helius intends to file its FDA submission for a stroke-related indication in the third quarter of 2025 under its Breakthrough Device Designation.

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