FDA Clears Tongue-Applied Neuromodulation System for Stroke Gait Rehabilitation

Gait impairment after stroke is a persistent driver of fall risk, loss of independence, and reduced quality of life. Despite structured rehabilitation, many adults continue to experience dynamic gait deficits that limit safe community ambulation. A newly cleared system now offers a non-invasive, tongue-applied neuromodulation option, used alongside physical therapy, for adults with chronic stroke-related gait dysfunction.

Bioness Medical’s PoNS (Portable Neuromodulation Stimulator) System has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the treatment of dynamic gait deficit due to chronic stroke symptoms. It is positioned as the first non-invasive, orally applied neuromodulation device FDA-cleared for stroke rehabilitation, intended to expand access for more than seven million Americans living with stroke-related gait disability. The new clearance expands PoNS’ indication beyond its existing approval in multiple sclerosis.

PoNS is a non-invasive, non-implantable, orally applied prescription device that delivers gentle neurostimulation through a mouthpiece placed on the tongue, used at home in conjunction with a physical rehabilitation exercise program. By stimulating branches of the trigeminal and facial cranial nerves, it activates direct connections to the brainstem and promotes neuroplasticity to help compensate for impaired corticospinal pathways, with the goal of improving walking function. For chronic stroke, the device is indicated as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and older by prescription only.

Regulatory clearance was supported by the Stroke Registrational Program, a three-study, 159-patient program conducted across 10 centers of excellence in the U.S. and Canada. Over 12 weeks of treatment plus a 12-week follow-up, the program evaluated primary endpoints for gait (Functional Gait Assessment, FGA) and balance (Berg Balance Scale, BBS), and key secondary endpoints including risk of falling and durability of effect. Analyses used propensity score methodology with multiplicity control via the Hochberg method.

Across studies, the primary endpoint for gait was met and statistically significant. Active PoNS plus physical therapy achieved an adjusted mean FGA change of 5.37 points at Week 12 versus 3.31 points with control (sham PoNS plus physical therapy), yielding a propensity-adjusted group difference of 2.06 (two-sided p=0.0233). Responder rates favored PoNS using a 6-point FGA threshold (56.1% vs 11.1%) and using ≥4- and ≥5-point thresholds (63.1% vs 33.3% and 58.5% vs 33.3%, respectively). Durability was demonstrated, with 89.7% meeting the prespecified performance goal; BBS and fall-risk outcomes numerically favored PoNS without between-group statistical significance. No treatment-related serious adverse events were reported, and adverse events (0.0%–14.8%) were unrelated to the device.

“The evidence from the registrational program demonstrate the superiority of active PoNS Therapy as compared to physical therapy alone, when applied in standard routine clinical settings for stroke rehabilitation. 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,” said Antonella Favit-Van Pelt, M.D., Ph.D., Bioness’ Chief Medical Officer.

“This FDA clearance is a major step forward for stroke rehabilitation and for the millions of patients suffering from stroke-related walking difficulties. PoNS is a non-invasive, prescription-based therapy that uses the brain's natural ability to rewire itself to help patients walk better and regain their independence. Built for home use, PoNS is easy to use, accessible, and affordable — and with Medicare coverage, it gives healthcare providers a dependable treatment option to help their patients regain functional mobility,” said Todd Cushman, CEO of Bioness.

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