Helius Medical Technology — a medical device company in Newtown — has received marketing clearance from the Food and Drug Administration, clearing its flagship product, writes John George for the Philadelphia Business Journal.
The device is a portable neuromodulator stimulator (PoNS). It was approvied for use as a short-term treatment of the gait deficiencies that affect walking in patients with mild-to-moderate symptoms of multiple sclerosis. It is designed to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age or older, solely by prescription.
“This milestone represents the most important achievement of our organization since its inception,” said Dane Andreeff, interim CEO of Helius.
The PoNS device, which consists of a controller and mouthpiece, delivers mild electrical stimulation to the surface of the tongue — where thousands of nerve fibers are located — to provide treatment of gait deficit.
Andreeff noted the PoNS is the first, and only, medical device cleared in the U.S. for the multiple sclerosis indication.
Already green-lit in Canada, the company will now focus on the commercial launch of its PoNS treatment domestically That launch is expected to happen in the first quarter of 2022.
More information on PoNS is available at the Philadelphia Business Journal.