Newtown Company Gets FDA Marketing Approval For MS Device

NEWTOWN, PA — A Bucks County neurotech company focused on neurological wellness has received marketing authorization from the U.S. Food and Drug Administration for a medical device designed to help patients with multiple sclerosis.

The Portable Neuromodulation Stimulator (PoNS™) device is the first and only tongue-delivered neuromodulation therapy for patients living with gait deficit, a common symptom of MS. It is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over, the company said.

Multiple sclerosis, or MS, is a chronic, degenerative disease that affects about 1 million people in the U.S. Many patients report suffering problems with their walking.

Dane Andreeff, Interim President and Chief Executive Officer of Helius, said the treatment has the potential to significantly improve an MS patient's ability to walk.

“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," Andreeff said. "Specifically, its safety and efficacy has 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."

Based in Newtown, Helius Medical Technologies, Inc. has 19 employees. The commercial launch of its PoNS treatment is expected to begin in early 2022, according to the Philadelphia Business Journal.

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