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HELIUS MEDICAL TECHNOLOGIES, INC. (OTCMKTS:HSDT) Files An 8-K Regulation FD Disclosure
Item 7.01

Regulation FD Disclosure

On September 4, 2018, Helius Medical Technologies, Inc. (the “Company”) issued a press release announcing the submission of a request to the U.S. Food and Drug Administration (“FDA”) for de novo classification and 510(k) clearance for the Portable Neuromodulation Stimulator (“PoNS®”) device with the FDA.A copy of the press release is furnished herewith as Exhibit 99.1.

The information set forth in this Item 7.01 and in the press release attached hereto as Exhibit 99.1, is deemed to be “furnished” and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section.The information set forth in this Item 7.01, including Exhibit 99.1, shall not be deemed incorporated by reference into any filing under the Exchange Act or the Securities Act of 1933, as amended, except to the extent that the Company specifically incorporates it by reference.

Item 9.01.Financial Statements and Exhibits.

(d)Exhibits

HELIUS MEDICAL TECHNOLOGIES, INC. Exhibit
EX-99.1 2 hsdt-ex991_6.htm EX-99.1 hsdt-ex991_6.htm Exhibit 99.1   Helius Medical Technologies Submits Request for FDA 510(k) Clearance of the PoNS™ Device   NEWTOWN,…
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About HELIUS MEDICAL TECHNOLOGIES, INC. (OTCMKTS:HSDT)

Helius Medical Technologies, Inc. is a medical technology company focused on neurological wellness. The Company focuses on developing, licensing or acquiring non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company is engaged in the development of its product, the portable neuromodulation stimulator (PoNS) device. The device, when used in combination with physiotherapy, is designed to enhance the brain’s ability to compensate for damage due to trauma or disease. The Company’s PoNS device is designed to induce cranial nerve non-invasive neuromodulation through an increase in stimulation of the facial and trigeminal nerves, which innervate the tongue. The PoNS device is developed to deliver to the tongue a non-invasive neurostimulation, in a form that induces neuromodulation. The PoNS device is an electrical pulse generator that delivers controlled electrical stimulation to the tongue.