Helius Medical Technologies has filed an application with the U.S. Food and Drug Administration (FDA) asking for de novo classification and clearance of its portable neuromodulation stimulator (PoNS) device for the treatment of walking deficits in multiple sclerosis (MS) patients.
The PoNS device is for use in combination with therapeutic exercise programs, and recently earned breakthrough device designation by the regulatory agency.
“Helius is excited to announce the submission of our request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from multiple sclerosis, to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age,” Philippe Deschamps, Helius’ president, CEO, and chairman, said in a press release.
“Our submission brings us a step closer to making our novel PoNS Treatment available for the 1 million U.S. patients estimated to be living with MS, a disease with a significant unmet medical need, particularly in addressing associated gait dysfunction,” Deschamps said.
PoNS is a non-invasive medical device that is placed — but not implanted — on top of the tongue and delivers mild electrical signals to the brainstem. The brainstem is a region at the base of the brain that regulates vital functions (e.g., heart rate, respiration), as well as sensory perception and movement, and is connected to the tongue by two major cranial nerves.
By sending these electrical impulses, the PoNS device is believed to increase the brain’s neuroplasticity, which essentially is the brain’s ability to adapt or rewire itself in response to new experiences. According to Helius, “the process of neuroplasticity underlies all cerebral learning, training and rehabilitation.”
Patients are expected to use the device in combination with targeted functional therapy, including physical, occupational, and cognitive exercises. The rewiring of brain structures and reactivation of nerve cells promoted by the device is expected to improve the process of rehabilitation.
The PoNS device recently was cleared in Canada for use as a short-term treatment (14 weeks) for walking problems due to mild-to-moderate MS symptoms, as well as for chronic balance problems due to traumatic brain injury. For both indications, the use of the device must be combined with physical therapy.
The recent filing to the FDA is asking for a de novo classification to the PoNS device, meaning that the regulatory agency agrees that no similar devices are legally marketed in the country and that the controls provided are enough to assure the safety and effectiveness of the device. In the event of a positive decision, the agency then provides a risk-based classification to the new device and authorizes its marketing.
“We look forward to the FDA’s review of our submission, as we strive to provide patients with gait deficit due to MS symptoms a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk,” Deschamps said.
PoNS also is under review by Australia’s Therapeutic Goods Administration (TGA).
We are sorry that this post was not useful for you!
Let us improve this post!
Tell us how we can improve this post?