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Helius Medical Technologies Inc (2)
Symbol HSM
Shares Issued 23,377,491
Close 2018-10-23 C$ 13.06
Market Cap C$ 305,310,032
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Helius Medical forms research JV with Feinstein in N.Y.

2018-10-24 09:38 ET - News Release

Mr. Mike Piccinino reports

HELIUS MEDICAL TECHNOLOGIES, INC. ANNOUNCES SECOND PARTNERSHIP TO IMPLEMENT CLINICAL EXPERIENCE PROGRAMS WITH PONSA TREATMENT IN THE UNITED STATES

Helius Medical Technologies Inc. has partnered with Northwell Health's Feinstein Institute for medical research in Manhasset, N.Y. This partnership will enable Helius to implement its second clinical experience program (CEP) for its portable neuromodulation stimulator (PoNS) -- an investigational medical device in the United States currently under review for market clearance by the United States Food & Drug Administration. PoNS is a licensed Class 2 medical device in Canada.

The CEP will be performed at three of Northwell Health's clinical sites including North Shore University Hospital (NSUH) and Transitions of Long Island in Manhasset, N.Y., and Southside Hospital in Bay Shore, N.Y.

CEPs are sponsored by Helius and implemented in partnership with leading neurorehabilitation centres, including academic and research institutions, hospital systems and high-volume independent neurorehabilitation centres. CEPs enable Helius to thoroughly investigate in the clinical setting, the PoNS treatment in patients suffering from chronic balance deficit due to mild- to moderate-traumatic brain injury (TBI).

"We are delighted to partner with NeuroHabilitation Corp., as we look to further treatment options for our patients who suffer from TBI," said Jamie Ullman, MD, director of neurotrauma at North Shore University Hospital, and principal investigator of the Feinstein Institute study. "PoNS treatment is a promising new technology which may enhance recovery after TBI by integrating tongue stimulation with specialized physical therapy."

"Helius is pleased to announce this important partnership with the Feinstein Institute for Medical Research," said Philippe Deschamps, Helius's chief executive officer. "Following our recently announced CEP partnerships with Ohio State University Wexner Medical Center, our partnership with the Feinstein Institute will enable us to implement our second CEP, which we are pursuing as part of our preregulatory clearance activities for the investigational PoNS device."

Mr. Deschamps continued: "By implementing CEPs, we aim to generate real-world clinical evidence and valuable health outcomes data, while building relationships with leading neurorehabilitation centres and key opinion leaders in the area of TBI. We look forward to working with Dr. Ullman and the staff at all of the participating Northwell Health clinical sites included in this CEP partnership to begin recruiting and enrolling patients for the PoNS treatment in the fourth quarter of 2018."

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.

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 & 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. PoNS is currently not commercially available in the United States or Canada.

PoNS 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. 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.

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