Clearance covers the treatment of dynamic gait deficit due to chronic stroke symptoms. It expands the indications for PoNS beyond the existing approval for multiple sclerosis (MS). The milestone comes just a few months after Bioness acquired the PoNS technology in April.
PoNS expands the company’s L300 Go and H200 wireless functional electrical stimulation (FES) technology platform to include the non-invasive neuromodulation of the central nervous system, delivered via the tongue. The technology leverages the stimulation of selective cranial nerve pathways to promote neuroplasticity and functional recovery.
PoNS is a non-invasive, non-implantable, orally applied prescription medical device. It delivers gentle neurostimulation through a mouthpiece placed on the tongue. Patients can use the system at home in conjunction with a physical rehabilitation exercise program.
The technology stimulates branches of the trigeminal and facial cranial nerves to activate direct connections to the brainstem. This promotes neuroplasticity mechanisms that facilitate the development of new neural networks to compensate for impaired corticospinal pathways. The company says this delivers reliable, durable improvements in walking function.
Commentary from Bioness officials
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.”
Dr. Antonella Favit-Van Pelt, Bioness chief medical officer, said:
“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.”
