FDA Clears PoNS Device for Stroke Rehabilitation, Expanding Neurostimulation Beyond MS Indication

Bioness Medical, Inc. announced FDA 510(k) clearance of the PoNS (Portable Neuromodulation Stimulator) System for the treatment of dynamic gait deficit due to chronic stroke symptoms, making it the first non-invasive, orally applied neuromodulation device cleared for stroke rehabilitation in the United States. The clearance expands PoNS beyond its existing FDA-cleared indication in multiple sclerosis (MS) and positions the home-use device as a prescription adjunct to supervised physical therapy for the more than 7 million Americans living with stroke-related gait disability.¹

The clearance is supported by the Stroke Registrational Program (SRP), a three-study, 159-patient program conducted across 10 centers of excellence in the US and Canada. In July 2025, then-manufacturer Helius Medical Technologies announced positive SRP outcomes and planned FDA submission under the device's Breakthrough Device designation, setting the stage for the clearance now granted under Bioness, which acquired the PoNS program from Helius.²

The PoNS device delivers mild electrical neurostimulation through a mouthpiece placed on the tongue, activating branches of the trigeminal and facial cranial nerves. These cranial nerves connect directly to the brainstem, and the stimulation is designed to promote neuroplasticity, facilitating the development of new neural networks to compensate for corticospinal pathway damage sustained during stroke. The device is used at home by the patient in conjunction with a physical rehabilitation exercise program, prescribed by a physician.

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In the pooled primary analysis of the SRP pivotal studies, active PoNS plus physical therapy produced a statistically significant adjusted mean change in Functional Gait Assessment (FGA) of 5.37 points (95% CI, 4.23 to 6.52) at week 12, compared with 3.31 points (95% CI, 1.96 to 4.76) in the sham PoNS plus physical therapy control group. The propensity-adjusted between-group difference was 2.06 points (95% CI, 0.29 to 3.84; P = .0233), meeting the Hochberg multiplicity requirement. Using a 6-point FGA increase threshold, 56.1% of active PoNS participants were classified as responders versus 11.1% of controls, a 45% increase in response rate.¹ Durability of effect was demonstrated through week 24, with a mean FGA reduction of less than 5% from the week 12 peak and 89.7% (95% CI, 81.8% to 97.5%) of participants meeting the pre-specified durability performance goal.¹

Balance improvement on the Berg Balance Scale (BBS) trended in favor of active PoNS but did not reach statistical significance in the between-group comparison. Risk of falling was resolved in 17.4% of active PoNS participants versus 8.9% of controls, also without statistical significance. No treatment-related serious adverse events were reported across the SRP trials, and adverse event rates ranged from 0% to 14.8%, with none attributable to the device.

“The totality of data in chronic stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by transitioning the outcome of physical therapy alone to a clinically meaningful effect with a 45.5% increased response rate to PoNS treatment as compared to PT alone,” Antonella Favit-Van Pelt, MD, PhD, Chief Medical Officer of Bioness, said in a statement.

The stroke clearance builds on a well-established regulatory and payer trajectory for PoNS in MS. The device received FDA de novo marketing authorization for MS-related gait deficit in 2021, and major commercial payers including UnitedHealthcare, Anthem, and Aetna have since authorized claims for the device in MS patients.³ Under the new stroke indication, Bioness has noted that Medicare coverage is available at launch, a meaningful access advantage given the predominantly older demographic of stroke survivors.¹

Bioness plans to begin making PoNS commercially available for stroke in Germany first, in close collaboration with MS specialists and rehabilitation physicians, accompanied by a required Risk Management Program and Patient Support Program.

REFERENCES
1. Bioness Medical announces 510(k) clearance for PoNS (Portable Neuromodulation Stimulator) to manage patients recovering from stroke. News release. Bioness Medical, Inc. June 29, 2026. Accessed June 29, 2026. https://www.prnewswire.com/news-releases/bioness-medical-announces-510k-clearance-pons-stroke-rehabilitation
2. Helius announces positive outcome of the Portable Neuromodulation Stimulator PoNS Stroke Registrational Program and upcoming submission to FDA under breakthrough designation. News release. Helius Medical Technologies. July 21, 2025. Accessed June 30, 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
3. Helius Medical Technologies, Inc. announces authorized claim for payment by major healthcare payer for its Portable Neuromodulation Stimulator (PoNS) device. News release. Helius Medical Technologies. June 11, 2025. Accessed June 30, 2025. https://www.globenewswire.com/news-release/2025/06/11/3097420/0/en/Helius-Medical-Technologies-Inc-Announces-Authorized-Claim-for-Payment-by-Major-Healthcare-Payer-for-its-Portable-Neuromodulation-Stimulator-PoNS-Device.html