FDA clears Bioness PoNS for chronic stroke gait deficit

The FDA has cleared Bioness Medical’s PoNS, or Portable Neuromodulation Stimulator, System for treating dynamic gait deficit caused by chronic stroke, according to the company. The 510(k) clearance broadens use of the tongue-applied neuromodulation device beyond its previous indication for gait deficit related to multiple sclerosis.

PoNS is a mouthpiece-based device that delivers gentle electrical stimulation to branches of the trigeminal and facial cranial nerves. The company says that stimulation activates connections to the brainstem. When used together with a supervised physical rehabilitation program, the therapy is intended to support neuroplasticity and help compensate for impaired corticospinal pathways that affect walking function.

The device is prescription only and is indicated for patients age 22 and older. According to the company, the newly cleared use is for adults with chronic stroke-related dynamic gait deficit.

The clearance is based on Bioness’ Stroke Registrational Program, a three-study effort involving 159 chronic stroke survivors with gait deficit across 10 centers in the United States and Canada. The program evaluated PoNS plus physical therapy against physical therapy alone over a 12-week treatment period, followed by an additional 12-week follow-up to assess whether effects were durable.

The primary endpoints in the studies were gait, measured with the Functional Gait Assessment, and balance, measured with the Berg Balance Scale. Secondary endpoints included fall risk and durability of improvement. The company reported that the pooled pivotal data showed an adjusted mean improvement of 5.37 points on the Functional Gait Assessment at 12 weeks in the active treatment group, compared with 3.31 points in the sham-device control group. Bioness said that between-group difference met statistical significance under multiplicity-adjusted analysis.

Using a 6-point improvement threshold on the Functional Gait Assessment, 56.1% of patients in the active-treatment group responded, compared with 11.1% in the control group. The company also said nearly 90% of patients in the active-treatment group 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. The company said that difference did not reach statistical significance.

Bioness reported no treatment-related serious adverse events across the program.

Antonella Favit-Van Pelt, MD, PhD, Bioness’ chief medical officer, said the evidence from the registrational program demonstrates the superiority of active PoNS Therapy compared with physical therapy alone when used in standard routine clinical settings for stroke rehabilitation. She also cited a 45.5% increased response rate for PoNS-treated patients relative to physical therapy alone.

Todd Cushman, Bioness’ CEO, said the clearance addresses a long-standing gap in stroke recovery options. He said the device is designed for home use and is covered by Medicare, which he described as giving clinicians a practical option for helping patients regain functional mobility outside the clinical setting.

PoNS now joins Bioness’ existing L300 Go and H200 Wireless functional electrical stimulation lines. In contrast with those peripheral nerve stimulation products, PoNS adds a non-invasive central nervous system approach to the company’s portfolio.

The clearance comes as the FDA has increasingly cleared neurotechnology aimed at mobility loss related to stroke and other neurological conditions. Devices using AI-driven sensor and stimulation systems have targeted gait and spasticity management, reflecting a move from passive mobility aids toward active rehabilitation tools that can adapt to patient needs.

Industry analysts have pointed to an aging population and rising stroke prevalence as drivers of growth in this device category. They have also noted payer interest in home-use technologies that may reduce reliance on costlier inpatient rehabilitation.

As more of these devices reach the market with Medicare coverage attached, physicians may see greater patient interest in supplementing standard physical therapy with prescription neurostimulation or robotic-assist options. That makes familiarity with the evidence behind individual devices increasingly relevant in treatment-planning discussions.

The company’s announcement did not report details beyond the clearance, the study program, and the performance and safety findings described above. It also did not provide additional information on implementation in clinical practice beyond noting that the device is prescription only, intended for supervised rehabilitation, and available for home use.

For patients living with chronic stroke-related gait problems, the clearance extends a device that was previously used in multiple sclerosis into a new rehabilitation setting. For clinicians, the FDA decision adds another option to the growing list of technologies aimed at helping patients improve walking function after stroke.

The evidence package for the clearance centered on a 159-patient, 10-site program, with results assessed over 12 weeks of treatment and 12 additional weeks of follow-up. Within that framework, Bioness said the active PoNS group showed better gait outcomes than physical therapy alone, along with a higher proportion of responders based on the study’s Functional Gait Assessment threshold.

The company framed the device as a tool to be used alongside supervised rehabilitation rather than as a stand-alone treatment. Its stated goal is to stimulate neural pathways in a way that supports recovery efforts for walking and balance after chronic stroke.

No further study details were reported in the source, including information about patient selection beyond age and chronic stroke status, or any additional breakdown of outcomes by center or subgroup. The announcement also did not include pricing information, launch timing, or any new physician guidance.

Even so, the clearance marks a notable expansion for Bioness, which has built its device portfolio around rehabilitation technologies. With PoNS now cleared for chronic stroke-related dynamic gait deficit in adults 22 and older, the company is positioning the product as another prescription option for clinicians working with patients whose mobility remains limited after stroke.