The FDA has authorized a new device to help adults with mild to moderate multiple sclerosis (MS) symptoms to walk.
The prescription-only Portable Neuromodulation Stimulator (PoNS) by Helius Medical Technologies (Newtown, Pa.) is intended for use in a supervised therapeutic exercise program in patients age 22 and older. The electrical pulse generator is applied to the tongue to stimulate the trigeminal and facial nerves to treat motor deficits.
The FDA assessed the safety and effectiveness of the PoNS device through two clinical studies and a retrospective analysis of real-world data, according to a news release. Helius also provided a retrospective analysis of real-world data collected with the PoNS device in MS patients in clinical rehabilitation settings.
“Today’s authorization offers a valuable new aid in physical therapy and increases the value of additional therapies for those who live with MS on a daily basis,” said Christopher M. Loftus, acting director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, in the release.
“For this vastly underserved population of MS patients with a clear medical need and few viable treatments, our innovative PoNS device and treatment represents a new therapeutic option with demonstrated results,” said Helius Medical CEO Dane Andreeff in a company statement. “Specifically, its safety and efficacy (have) been demonstrated in two clinical studies and a retrospective analysis of real-world data which were submitted to, and assessed by, the FDA as part of our request for marketing authorization. The receipt of FDA marketing authorization represents an important validation of both the strength and quality of this supporting data, and ultimately the safety and efficacy of our PoNS device.”
The FDA granted PoNS breakthrough device designation following a review through the De Novo premarket review pathway, a regulatory pathway for low-to moderate-risk devices of a new type.