NEWTOWN, Pa., March 05, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has begun treating patients in Canada with the Company’s Portable Neuromodulation Stimulator (PoNS™) Treatment.
“We are excited to announce the treatment of the first patients in Canada with our PoNS™ device, signifying Helius’ transition to a commercial stage company,” said Philippe Deschamps, Helius’ Chief Executive Officer. “With approximately 400,000 individuals living with chronic balance issues due to a mild to moderate traumatic brain injury (“mTBI”), Canada represents an important market opportunity for Helius. We look forward to providing our innovative PoNS Treatment to all of those suffering from this condition in Canada.”
Helius received authorization from Health Canada to market the PoNS device as an adjunct to physical therapy for chronic balance deficit in patients with mTBI in October 2018. The patients are being treated at one of two neuroplasticity clinics identified by Heuro Canada Inc., which was formed through Helius’ strategic alliance with HealthTech Connex Inc.
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 (PoNS). For more information, visit www.heliusmedical.com.
About the PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS) is a licensed class II, noninvasive, medical device in Canada indicated for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury when used in conjunction with physical therapy. PoNS is an investigational medical device in the United States and the European Union (EU), it is currently under review for clearance by US FDA and by an EU Notified Body. PoNS is currently not commercially available in the United States or the European Union.
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 success of the Company’s commercial launch in Canada, ongoing or planned clinical research, expected future development timelines, regulatory approvals, business and commercialization initiatives and objectives and the potential receipt of 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 commercial launch of a new therapeutic treatment, the FDA regulatory submission and approval process, including the Company’s capital requirements 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, 2017, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2018 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.
Investor Relations Contact:
Westwicke on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA