FDA clears Bioness PoNS device for chronic stroke gait deficit

Bioness Medical's PoNS (Portable Neuromodulation Stimulator) System has received FDA 510(k) clearance for treating dynamic gait deficit caused by chronic stroke, the company announced. The clearance expands use of the tongue-applied neuromodulation device beyond its existing indication for gait deficit due to multiple sclerosis.

The mouthpiece-based device delivers gentle electrical stimulation to branches of the trigeminal and facial cranial nerves, activating connections to the brainstem. Used alongside a supervised physical rehabilitation program, the therapy is intended to promote neuroplasticity that helps compensate for impaired corticospinal pathways affecting walking function. The device is prescription-only and indicated for patients 22 and older.

Clearance rests on the Stroke Registrational Program, a three-study effort spanning 159 chronic stroke survivors with gait deficit across 10 U.S. and Canadian centers. The studies compared active PoNS plus physical therapy against physical therapy alone over a 12-week treatment period, with an additional 12-week follow-up to assess durability of effect. Primary endpoints were gait, measured by the Functional Gait Assessment, and balance, measured by the Berg Balance Scale; secondary endpoints included fall risk and durability of improvement.

The pooled pivotal data showed an adjusted mean FGA improvement of 5.37 points at 12 weeks in the active treatment group, compared with 3.31 points in the sham-device control group — a between-group difference that met statistical significance under multiplicity-adjusted analysis. Using a 6-point FGA improvement threshold, 56.1% of active-treatment patients responded versus 11.1% of controls. Most patients maintained their gains: nearly 90% met the study's durability benchmark at the 12-week follow-up mark. Risk of falling was resolved in 17.4% of the active-treatment group compared with 8.9% of controls, though that difference did not reach statistical significance. The company reported no treatment-related serious adverse events across the program.

"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," said Antonella Favit-Van Pelt, M.D., Ph.D., Bioness' chief medical officer, citing a 45.5% increased response rate for PoNS-treated patients relative to physical therapy alone.

Todd Cushman, Bioness' CEO, framed the clearance as addressing a long-standing gap in stroke recovery options. He noted the device is built for home use and is covered by Medicare, which he said gives clinicians a practical option for helping patients regain functional mobility outside the clinical setting.

PoNS joins Bioness' existing L300 Go and H200 Wireless functional electrical stimulation lines, adding a non-invasive central nervous system approach to a portfolio that has otherwise relied on peripheral nerve stimulation.

The clearance lands amid a broader expansion of FDA-cleared neurotechnology aimed at stroke-related mobility loss. Devices using AI-driven sensor and stimulation systems have increasingly targeted gait and spasticity management for stroke and other neurological conditions, reflecting a shift from passive mobility aids toward active, adaptive rehabilitation tools. Industry analysts have pointed to an aging population and rising stroke prevalence as key drivers of growth in this device category, alongside payer interest in home-use technologies that can reduce reliance on costlier inpatient rehabilitation. As more of these devices reach the market with Medicare coverage attached, physicians may see growing patient interest in supplementing standard physical therapy with prescription neurostimulation or robotic-assist options, making familiarity with the evidence base behind individual devices increasingly relevant to treatment planning conversations.