FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

 

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FDA clears Bioness Medical’s neuromodulation system for stroke rehabilitation

Bioness’s PoNS system is designed to improve gait impairment in stroke patients by stimulating the trigeminal and facial cranial nerves.

Bioness Medical’s oral neuromodulation system for rehabilitating stroke patients with gait deficits has secured clearance from the US Food and Drug Administration (FDA). The California-based company’s portable neuromodulation stimulator (PoNS) system delivers neurostimulation through a mouthpiece placed on the tongue. Designed for at-home use in conjunction with physical rehabilitation, the prescription-only device stimulates branches of the trigeminal and facial cranial nerves, activating direct connections to the brainstem. This treatment approach promotes the development of new neural networks to compensate for impaired corticospinal pathways, with the aim of improving walking function in individuals following a stroke, Bioness stated. The device’s clearance for stroke rehabilitation was supported by Bioness’s three-study Stroke Registrational Program (SRP) that evaluated PoNS’ safety and efficacy in conjunction with physical rehabilitation therapy as compared to physical therapy (PT) alone over a 12-week treatment period. Bioness acquired the PoNS system product line from original developer Solana Company (formerly known as Helius Medical Technologies) in April 2026. Prior to the transaction, for which financial terms were not publicly disclosed, PoNS held an FDA indication for multiple sclerosis (MS) treatment.&mThe 159-patient SRP met its primary endpoint, with statistically significant improvements on the Functional Gait Assessment (FGA) scale. Treatment with PoNS plus PT led to an adjusted mean change in FGA of 5.37 points at week 12, versus a non-clinically meaningful change of 3.31 points in the control group. Meanwhile, 45% more subjects treated with PoNS responded to treatment on the basis of a six-point FGA increase threshold, with at least 30% more on the basis of a ≥4-point or ≥5-point improvement threshold. Bioness’ CMO, Antonella Favit-Van Pelt, commented: “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.”

Neuromodulation is having a significant impact in the healthcare space for the treatment of conditions ranging from sleep apnoea and chronic migraine to major depressive disorder (MDD). According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of over $13bn in 2035, up from around $6.8bn in 2025.