Item 7.01 Regulation FD.

On January 11, 2021, Helius Medical Technologies, Inc. (the "Company") issued a press release announcing its submission of a response to the U.S. Food and Drug Administration in pursuit of de novo classification and clearance of the Portable Neuromodulation Stimulator (PoNS™) device for the treatment of gait deficit due to symptoms of Multiple Sclerosis. A copy of the press release is attached hereto as Exhibit 99.1.

The information in this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished, shall not be deemed "filed" for any purpose, and shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.




Item 8.01 Other Events.

On January 11, 2021, the Company announced that it has submitted its formal response to the U.S. Food and Drug Administration's request for additional information received in October 2020, which related to the Company's request for de novo classification and clearance of the PoNS™ device as a potential treatment for gait deficit due to symptoms of Multiple Sclerosis, to be used as an adjunct to a supervised therapeutic exercise program in patients over 18 years of age.

Item 9.01 Financial Statements and Exhibits.





(d) Exhibits.



Exhibit   Description
 99.1       Press Release, dated January 11, 2021  .





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