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Helius Medical Technologies, Inc. Submits Response to U.S. FDA in Pursuit of De Novo Classification and Clearance of the PoNS™ Device for the Treatment of Gait Deficit Due to Symptoms of Multiple Sclerosis
Submits formal response to the U.S. Food and Drug Administration’s request for additional information NEWTOWN, Pa., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Helius
About this update from Solana Company
[{"type":"text","content":"Submits formal response to the U.S. Food and Drug Administration’s request for additional information\nNEWTOWN, Pa., Jan. 11, 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 it has submitted its formal response to the U.S. Food and Drug Administration’s (the “FDA” or “Agency”) request for additional information. The FDA’s request for additional information was related to the Company’s request for de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis (“MS”), to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age. “The Helius team is very excited to announce the timely submission of our response to the FDA’s request for additional information,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “The achievement of this important milestone was made possible by the diligent efforts of our regulatory and clinical affairs team, and I would like to thank them for their hard work and dedication in recent months.” Mr. Andreeff continued: “Looking ahead, we expect that the FDA’s receipt of our response will enable the FDA to resume its review of our request for de novo classification and clearance. We remain committed to our goal of bringing our PoNS technology to the aid of U.S. patients suffering with gait deficit due to MS-related symptoms as expeditiously as possible, and hope to receive the FDA’s decision on our request for de novo classification and clearance during the first half of this year.” Additional Background Information: Helius submitted its request for de novo classification and clearance of the PoNS device for the treatment of gait deficit due to symptoms from MS on August 4, 2020, following the receipt of Breakthrough Designation by FDA in early May. On October 19, 2020, the Company announced the receipt of the FDA’s request for additional information, which was received approximately 75 days following the submission date and placed the FDA’s review on hold until receipt by the FDA of the requested information. About Helius Medical Technologies, Inc. Helius Medical Technologies is a neurotech ...