NEWTOWN, Pa., Jan. 16, 2020 — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, announces that it has entered into an agreement with the University Health Network (UHN) to perform a clinical experience program to enable it and three independent neurorehabilitation clinics in Canada to evaluate the Company’s Portable Neuromodulation Stimulator (PoNS™) device, in conjunction with physical therapy, on patients with chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) in Canada.
“When innovative technologies that have received Health Canada approval such as the PoNS device are deployed in Canada, it is important for the medical and healthcare establishment to have an opportunity to gain experience with the technologies to help decide the extent to which they can be incorporated into their clinical practices. It also provides an opportunity for a large medical research hospital such as University Health Network to work with other healthcare clinics to build a strong and extensive network of medical institutions that can accelerate clinical knowledge, experience and deployment of innovative technologies in Canada,” said Dr. Milos Popovic, Director of The KITE Research Institute (KITE), a research institute within University Health Network.
“As the PoNS device is relatively new in Canada, we are pleased that Helius supports our desire to evaluate its technology under a clinical program to help determine the extent to which the technology can form part of clinical practice in treating patients with chronic balance deficit due to mmTBI. Canadian patients wishing to participate in this clinical program which utilizes the PoNS technology can call (416) 597-3422 extension 6340 or visit www.rocketclinic.ca to determine if they would qualify,” said Dr. Sukhvinder Kalsi-Ryan, Affiliate Scientist at KITE, and lead scientist in the PoNS clinical program at KITE.
“We are honored that University Health Network, through KITE, is participating with Helius in this clinical program and coordinating clinical activities with independent neurorehabilitation centers in Canada. This clinical experience program will help us understand how this technology can fit in the treatment of patients who have suffered a mmTBI resulting in a chronic balance deficit,” said Philippe Deschamps, Chief Executive Officer of Helius.
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 commercial product in Canada is the Portable Neuromodulation Stimulator (PoNS™). For more information, visit www.heliusmedical.com.
About The KITE Research Institute at University Health Network
KITE is the research arm of the Toronto Rehabilitation Institute and one of the principle research enterprises at the University Health Network (UHN), Canada’s largest medical research hospital. KITE is a world leader in the field of complex rehabilitation research, with scientists and staff dedicated to improving the lives of people living with the effects of disability, illness and aging.
At KITE, our mission is to be a trailblazer in research, education, knowledge translation and clinical application.
About the PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is an authorized class II, non-implantable, medical device in Canada intended for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The PoNS is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”), and it is currently under review for clearance by the AUS Therapeutic Goods Administration. PoNS Treatment™ is not commercially available in the United States, the European Union or Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc. Mike Piccinino, CFA 443-213-0500 [email protected]
Cautionary Disclaimer Statement:
Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “continue,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future clinical and regulatory development plans for the PoNS device, the commercialization of the PoNS device in Canada and the potential regulatory clearance of the PoNS device.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the uncertainties associated with the regulation of commercially available medical devices in Canada, including Health Canada’s ongoing assessment of post-market data, the clinical development, regulatory submission and approval process in the United States, the European Union and Australia, as well as the Company’s capital requirements needed to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2018, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.