Mr. Philippe Deschamps reports

HELIUS MEDICAL TECHNOLOGIES SUBMITS REQUEST FOR FDA 510(K) CLEARANCE OF THE PONS DEVICE

Helius Medical Technologies Inc. has submitted a request to the U.S. Food and Drug Administration (FDA) for de novo classification and 510(k) clearance of the portable neuromodulation stimulator (PoNS) device.

"Helius is excited to announce the submission of our request for de novo classification and 501(k) clearance of the PoNS device for the treatment of chronic balance deficit due to mild to moderate traumatic brain injury," said Philippe Deschamps, Helius's president, chief executive officer and chairman. "This important milestone is the result of many years of hard work from the Helius team, and it brings us one step closer to making our novel PoNS treatment available for U.S. patients who suffer from the potentially disabling effects of TBI-related chronic balance disorder."

The company's request for de novo classification and 510(k) clearance is supported by clinical data from two double-blind, randomized, controlled trials demonstrating the PoNS device's safety and efficacy, with combined enrolment of 163 patients. It is also informed by feedback provided by FDA during presubmission meetings that focused on the company's trial designs, clinical data and design verification testing.

Mr. Deschamps continued, "Looking ahead, the company is focused on laying the groundwork for the commercial launch of our PoNS treatment following FDA clearance and pursuing regulatory clearances in Canada, Australia, Europe."

About Helius Medical Technologies Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The company's purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain's ability to heal itself. The company's first product in development is the portable neuromodulation stimulator (PoNS).

About the PoNS device and PoNS treatment

The portable neuromodulation stimulator (PoNS) is an investigational, non-invasive, medical device. PoNS treatment is the first and only tongue-delivered neuromodulation that combines stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function. The company's trials investigating the PoNS in traumatic brain injury are more fully discussed in the company's disclosure materials, including its annual report on Form 10-K and other filings with the United States Securities and Exchange Commission.

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