Bioness Medical has received FDA 510(k) clearance for its PoNS (Portable Neuromodulation Stimulator) system to treat dynamic gait deficit caused by chronic stroke symptoms. This regulatory milestone significantly expands the commercial indications for the device, building upon its previous authorization for patients suffering from multiple sclerosis (MS). The clearance arrives just months after Bioness strategically acquired the PoNS technology in April.
The PoNS system is a non-invasive, prescription-based medical device designed for home use alongside a structured physical rehabilitation program. It consists of a specialized mouthpiece that delivers gentle electrical stimulation directly to the patient’s tongue. By integrating PoNS into its existing portfolio of wireless functional electrical stimulation (FES) systems, Bioness is transitioning from peripheral nerve stimulation into targeted modulation of the central nervous system.
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The device works by stimulating selective cranial nerve pathways on the tongue, specifically targeting branches of the trigeminal and facial nerves. This electrical stimulation activates direct neural pathways to the brainstem, triggering neuroplasticity – the brain’s natural ability to reorganize and rewire itself. Clinical data submitted for the clearance demonstrated a 45.5% increased response rate in walking function improvement when combining PoNS therapy with physical therapy compared to physical therapy alone.
Todd Cushman, Bioness CEO, said: “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.”
