Helius Medical Technologies Receives Medical Device License Clearance from Health Canada for PoNS Device

Helius Medical Technologies (NASDAQ:HSDT) (TSX:HSM) a neurotech company focused on neurological wellness, today announced its wholly owned subsidiary, NeuroHabilitation Corporation, received authorization from Health Canada to market its Portable Neuromodulation Stimulator (PoNS™), a class II medical device in Canada.

As quoted in the press release:

The Health Canada Medical Device License certifies the PoNS Device meets all Canadian safety, effectiveness, and quality requirements. The Canadian Medical Device License 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),” said Philippe Deschamps, Helius’ President, CEO and Chairman. “Canada is one of the most respected healthcare 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.”

Click here to read the full press release.