Helius’ PoNS Neurostimulation Device Advances Toward Stroke Indication Following Registrational Program Data

Antonella Favit-Van Pelt, MD, PhD

Helius has announced positive data from its Stroke Registrational Program (SRP) that supports the use of its Portable Neuromodulation Stimulator (PNS) Device as a beneficial treatment for poststroke patients with gait or balance deficits. Based on these new findings, the company is planning a formal submission to the FDA in the third quarter to expand its indication in this patient population.¹

Stemming from positive conversations with the FDA, the SRP comprised 3 studies, including a double-blind, randomized controlled trial and a single-arm trial. Results revealed that the double-blind randomized trial met its primary end point, with those on the PoNS device demonstrating statistically significantly greater improvements in gait and/or balance deficit due to stroke. Notably, this finding was found with and without including additional data from an open-label study using statistical methods to balance baseline characteristics.

A total of 159 patients made up the trials, 130 of which completed their respective 12-week study treatment phases and the 12-week post-treatment follow-up period. Both the sham and active groups received physical therapy in addition to their treatment that was in accordance with the current guidelines for functional rehabilitation of patients with chronic stroke.

"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," Antonella Favit-Van Pelt, MD, PhD, chief medical officer, Helius, said in a statement.¹ "We look forward to releasing the SRP’s study results this quarter and to continuing working closely with FDA under the upcoming application for authorization of the Agency’s breakthrough designated PoNS device."

The PoNS device, a non-invasive approach through targeted stimulation of the tongue, was first approved in Canada in 2018 in 3 indications, including gait deficit due to multiple sclerosis (MS) and stroke, and balance deficit linked to mild-to-moderate traumatic brain injury. Years later, in 2021, the FDA granted de novo marketing authorization for PoNS as a Class II device, indicated for short-term treatment of gait deficit related to mild-to-moderate symptoms of MS.

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All 3 of the trials included in the SRP had the same patient population, the same study structure and end points, each aimed at furthering the knowledge profile of PoNS in poststroke patients with gait. In the latest SRP data announcement, Helius noted a minimal number of adverse events in the studies, with the PoNS device demonstrating “good” treatment tolerability.

In a 2024 interview with NeurologyLive, Favit-VanPelt commented on the uniqueness of the device, noting that "Unlike transcranial stimulation (TCS) in the lab, PoNS has the advantage of being readily accessible to the patient, allowing a great deal of autonomy and independence, empowering patients to use the system regularly and consistently at home and, as such, potentiate the neuromodulation mechanisms that lead to sustained neuroplasticity and, consequently, consolidated therapeutic effects."

She added, "Conversely, PoNS is itself a neuromodulation therapy: Predominantly used by the patient at home, PoNS stimulates cranial (not peripheral) nerves that are directly connected to brain areas that regulate movement functions. PoNS stimulation, even before starting physical therapy, increases blood flow in these areas, promoting a sustainable neuromodulation and, over time, neuroplasticity."

Earlier this year, data from the pivotal PoNSTEP trial further showcased the device’s ability to treat gait deficit in patients with MS. The study included 43 patients with mild-to-moderate MS and gait deficits who underwent 14 weeks of PoNS therapy—2 weeks in-clinic, 12 weeks at home—followed by 6 months of observation. Among the 38 patients who completed treatment, investigators reported a statistically significant mean improvement of 5.00 points (95% CI, 4.1–5.9; P <.0001) on the Dynamic Gait Index at week 14.²

The data from PoNSTEP was notable in that it was the first clinical evidence linking adherence to PoNS therapy, along with targeted exercise, to improve gait deficits and sustained therapeutic effects in patients with MS 6 months post-treatment. In phase 2 of the trial, adherence to therapy was 71%, with gait improvement showing a significant linear association with adherence (r = .345; P = .034). In phase 1, adherence was higher at 89.5% but showed no such association. Across both phases, participants with at least 85% adherence improved a mean of 3.7 points (SD 1.8) on gait measures, compared with 2.0 points (SD 1.8) in those with lower adherence (P = .008).

REFERENCES
1. Helius Announces Positive Outcome of the Portable Neuromodulation Stimulator PoNS® Stroke Registrational Program and Upcoming Submission to FDA Under Breakthrough Designation. News release. Helius. July 21, 2025. Accessed July 22, 2025. https://www.globenewswire.com/news-release/2025/07/21/3118588/0/en/Helius-Announces-Positive-Outcome-of-the-Portable-Neuromodulation-Stimulator-PoNS-Stroke-Registrational-Program-and-Upcoming-Submission-to-FDA-Under-Breakthrough-Designation.html
2. Helius Medical Technologies, Inc. Announces First Clinical Evidence of Positive Long-term Therapeutic Effects of PoNS Therapy® on Gait Deficit Improvement in Multiple Sclerosis from the PoNS® Therapeutic Experience Program Study. News release. Helius Medical Technologies. January 22, 2025. Accessed July 22, 2025. http://globenewswire.com/news-release/2025/01/22/3013331/0/en/Helius-Medical-Technologies-Inc-Announces-First-Clinical-Evidence-of-Positive-Long-term-Therapeutic-Effects-of-PoNS-Therapy-on-Gait-Deficit-Improvement-in-Multiple-Sclerosis-from-t.html