Bioness’ PoNS System Wins FDA Nod to Treat Gait Deficit Due to Stroke

Bioness Medical announced that its PoNS (Portable Neuromodulation Stimulator) has earned U.S. Food and Drug Administration (FDA) to treat dynamic gait deficit due to chronic stroke symptoms.

The clearance was supported by the Stroke Registrational Program (SRP), a three-study, 159-patient program at ten centers of excellence in the U.S. and Canada. The studies showed a sustained, statistically significant, and clinically meaningful improvement in dynamic gait deficit versus physical therapy alone, with a favorable safety profile.

The PoNS system grows the company’s L300 Go and H200 Wireless FES tech platform to include a non-invasive neuromodulation of the central nervous system, delivered via the tongue, by using stimulation of selective cranial pathways to promote neuroplasticity and functional recovery.

The primary analysis of the pooled pivotal randomized controlled and single-arm studies demonstrated that treatment with active PoNS plus PT led to a statistically significant and clinically meaningful adjusted mean change in FGA of 5.37 points (95% CI: 4.23 to 6.52) at Week 12 as compared to a non clinically meaningful change of 3.31 points (95% CI 1.96 to 4.76) in the control group (sham PoNS plus PT) in the primary per-protocol dataset.

Comments from Bioness

Antonella Favit-Van Pelt, MD, Ph.D., chief medical officer, Bioness: “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.”

Todd Cushman, CEO, Bioness: “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.”