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Helius Medical Technologies Inc (2)
Symbol HSM
Shares Issued 23,377,491
Close 2018-10-22 C$ 13.26
Market Cap C$ 309,985,531
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Helius Medical receives medical device licence for PoNS

2018-10-22 09:32 ET - News Release

Mr. Philippe Deschamps reports

HELIUS MEDICAL TECHNOLOGIES RECEIVES MEDICAL DEVICE LICENSE CLEARANCE FROM HEALTH CANADA FOR PONS DEVICE

Helius Medical Technologies Inc.'s NeuroHabilitation Corp. has received authorization from Health Canada to market its portable neuromodulation stimulator (PoNS), a Class II medical device in Canada. The Health Canada medical device licence certifies the PoNS device meets all Canadian safety, effectiveness and quality requirements. The Canadian medical device licence approval was preceded by the company's achievement of ISO 13485 certification, the international standard for medical device quality management systems.

"The company is thrilled to have received Canadian regulatory clearance to market our PoNS treatment as an adjunct to physical therapy for chronic balance deficit in patients with mild-to-moderate traumatic brain injury (TBI)," commented Philippe Deschamps, Helius Medical Technologies' president, chief executive officer and chairman. "Canada is one of the most respected health care markets in the world and was, therefore, well represented in our successful TBI clinical trial. We are excited to have this first regulatory confirmation on the benefits of our breakthrough PoNS treatment. We thank Health Canada for its rapid review and clearance of our application. We look forward to providing our innovative treatment for this very high unmet medical need to Canadians suffering from the chronic effects of TBI.

"Earlier this month, we announced the creation of Heuro Canada, a new operating entity formed as part of our strategic alliance with HealthTech Connex (HTC) to distribute PoNS treatment in Canada, once clearance was obtained. Through Heuro Canada, we are working expeditiously to build the requisite commercial and operating infrastructure to begin treating patients now that we have received regulatory clearance for the PoNS treatment. We have already established the first two Heuro Canada neuroplasticity clinics, which we expect to be operational in the fourth quarter of 2018, and we expect to begin treating patients in Canada in the first quarter of 2019."

About Helius Medical Technologies Inc.

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

About the PoNS device and PoNS treatment

The portable neuromodulation stimulator is an investigational, non-invasive medical device currently under review by the U.S. Food and Drug Administration and Health Canada for clearance to improve balance in patients following a mild-to-moderate traumatic brain injury (mTBI) when combined with targeted physical therapy. The portable neuromodulation stimulator treatment is the first and only tongue-delivered neuromodulation being developed to combine stimulation of cranial nerves with physical and cognitive therapy to restore lost neurological function. Helius Medical Technologies' trials investigating the portable neuromodulation stimulator 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 U.S. Securities and Exchange Commission.

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