HELIUS MEDICAL TECHNOLOGIES, INC. (OTCMKTS:HSDT) Files An 8-K Other Events
Item 8.01Other Events.
On January 25, 2019, Helius Medical Technologies,Inc. (the “Company”) issued a press release providing an update on the U.S. Food and Drug Administration’s review of the Company’s request for de novo classification and 510(k) clearance of its Portable Neuromodulation Stimulator (PoNS™) device in the United States. A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 9.01Financial 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,…
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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.
