Helius Medical Technologies (HSM.T) subsidiary, Helius Medical, received the go-ahead from the Food and Drug Administration to take their portable neuromodulation stimulator (PoNS) device to market.
The PoNS device works with multiple sclerosis patients to help them as a short-term treatment of mobility issues, and more specifically gait deficits caused by the disease, to be used in connection with a supervised therapeutic exercise program in patients 22 years old and up and only as a medication.
“MS is a chronic, degenerative and often debilitating disease that is estimated to affect approximately 1 million patients in the U.S. Many of these patients experience problems with their gait, or walking, as a result of MS which can severely restrict their mobility and daily activities. Our aim in obtaining marketing authorization is to provide MS patients suffering from gait deficit with a non-drug, non-implantable treatment that has the potential to significantly improve their ability to walk, and potentially enhance their safety and quality of life as a result,” said Dane Andreeff, interim president and chief executive officer of Helius in a press release.
Helius Medical Technologies’ is a neurotech company and their focus, perhaps unsurprisingly, is on neurological wellness. They develop, license nad acquire non-invasive platform technologies that can amplify the brain’s ability to heal itself. PoNS is their first marketable product.
PoNS is a non-surgical medical device, including a controller and mouthpiece, which uses electricity to stimulate to the surface of the tongue as a treatment for gait deficit, and has been indicated for use in the United States as a short term treatment for such. The device is authorized for sale in Canada as a class II, non-implantable, medical device used for the same purpose, but also to treat balance deficits due to mild-to-moderate brain injury, used alongside traditional physical therapy.
It’s status in in the European Union and Australia is a little more nebulous, having only gained investigational medical device by their regulators, and is presently under premarket review by the AUS Therapeutic Goods Association.
“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. 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,” said Andreeff.
Helius is down $1.97 today, and closed at $20.98.