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Helius Medical, Inc Receives U.S. Marketing Authorization for the PoNS™ Device
First and only tongue-delivered neuromodulation therapy provides new treatment option for U.S. patients living with gait deficit due to symptoms from multiple
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[{"type":"text","content":"First and only tongue-delivered neuromodulation therapy provides new treatment option for U.S. patients living with gait deficit due to symptoms from multiple sclerosis\nNEWTOWN, Pa., March 29, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that its wholly owned subsidiary, Helius Medical, Inc, has received marketing authorization from the U.S. Food and Drug Administration (“FDA”) for the Portable Neuromodulation Stimulator (PoNS™) device. The PoNS device is indicated for use as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (“MS”) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only . “With the receipt of FDA marketing authorization, Helius is proud to announce that our PoNS device is now the first, and only, medical device cleared in the U.S. for this indication,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “This milestone represents the most important achievement of our organization since its inception, and I would like to thank our dedicated employees, our shareholders, and the people who participated in the research for making it possible. 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.” Mr. Andreeff continued: “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 requ...