Helius Medical Technologies, Inc. Submits Response to U.S. FDA in Pursuit of De Novo Classification and Clearance of the Ponstm Device for the Treatment of Gait Deficit Due to Symptoms of Multiple Sclerosis

Helius Medical Technologies, Inc. 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 (PoNSTM) 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.