Helius Medical Technologies Receives Canadian Clearance for PoNS Device

Helius Medical Technologies Inc., a neurotech company focused on neurological wellness, 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. 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.”

The Portable Neuromodulation Stimulator (PoNS) is a Class II Medical Device cleared for commercial distribution in Canada and an investigational, non-invasive, medical device currently under review by the U.S. Food and Drug Administration for clearance to improve balance in patients following a mild-to-moderate traumatic brain injury (mTBI) when combined with targeted physical therapy. PoNS treatment is the first and only tongue-delivered neuromodulation treatment being developed to combine 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 U.S. Securities and Exchange Commission.
 
“[In October], 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,” Deschamps said. 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.”  
 
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).
 
HealthTech Connex Inc. is a health technology company working to revolutionize the practice of clinical neuroscience through advanced technologies based on the highest quality science and innovation. Located in Surrey, British Columbia, Canada, it is one of the first companies to emerge from the city’s Innovation Boulevard, an agile partnership of health, business, higher education and government creating new health technologies to improve peoples’ lives.