Medical Device

NASDAQ:HSDT

The company’s share price saw a jump of 15.85 percent to US$10.16 after the news about its PoNS device was released on Monday.

Helius Medical Technologies (NASDAQ:HSDT,TSX:HSM) has received a positive nod from Health Canada for its Portable Neuromodulation Stimulator (PoNS) device.

The news, which was released Monday (October 22), clears the product for mild to moderate traumatic brain injury (TBI) in Canada. When combined with physical therapy, the PoNS device is the first and only tongue-delivered neuromodulation treatment to restore lost neurological function.

“We are excited to have this first regulatory confirmation on the benefits of our breakthrough PoNS Treatment,” Helius CEO Philippe Deschamps said in a press release. “We thank Health Canada for its rapid review and clearance of our application.”

The device accumulates almost four decades of experience on neuromodulation. This form of stimulation is supposed to provoke the brain’s ability to restructure and relearn in response to new experiences, sensory input and functional demands. This could aid with training, rehab and cerebral learning.

Through the tongue, the device stimulates nerves attached to lower parts of the brain, including the trigeminal and facial nerves. This is how the device operates by just working on the tongue.

The company’s application for a Class 2 Medical Device License was submitted in late September of this year. The device’s approval came from its ISO 13485 Certification, which outlines specific international standards for medical device quality-management systems.

Earlier in October, Helius and HealthTech Connex announced a partnership to build Canadian commercial infrastructure to develop and manage neuroplasticity clinics in Canada. The new operating entity from the partnership is Heuro Canada, and the approval for TBI is the next step to helping patients.

Heuro will also help with expansion for HealthTech Connex’s product, the NeuroCatch Platform. The companies plan to submit the NeuroCatch for Health Canada clearance in Q1 2019.

Two Heuro Canada clinics have already been established in Canada, and Helius expects to begin treating patients in Canada as early as Q1 2019.

The company is still awaiting approval for the PoNS system from the US Food and Drug Administration for the same TBI indication.

The PoNS system is Helius’ only device currently. The company is focused on neurological wellness with the device, which is the same goal as the joint project Heuro Canada.

Investor takeaway

Helius’ share price saw an impressive jump of 15.85 percent to US$10.16 on Monday.

TipRanks shows one analyst has given the company a rating over the past few months. Sean Lavin with BTIG reiterated a “hold” rating for the company.

With this recently announced partnership and the Health Canada clearance, investors should continue to see news over the quarter and into Q1 2019 regarding the Heuro Canada clinics and more.

Don’t forget to follow@INN_LifeScience for real-time updates!

Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.

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