NEWTOWN, PENNSYLVANIA–(Marketwired – Dec. 5, 2016) – Helius Medical Technologies, Inc. (TSX:HSM)(TSX:HSM.S)(OTCQB:HSDT) (“Helius”) along with the Tactile Communication and Neurorehabilitation Laboratory (TCNL) of University of Wisconsin-Madison, are pleased to announce the last subject has been randomized in a 44-subject clinical trial, investigating PoNS™ Therapy for the treatment of chronic balance deficits due to traumatic brain injury (TBI), and the trial is now fully enrolled.
Subjects in the trial participate in 14-weeks of PoNS™ Therapy training, followed by a 12-week follow up period to assess the durability of response. Based on this treatment timeline, the expected completion date of the 44-subject study is late May, 2017. Full trial details are available at:
https://clinicaltrials.gov/ct2/show/NCT02158494?term=NCT02158494&rank=1
“The tireless efforts and dedication shown by the team at TCNL in achieving full recruitment are a testament to their commitment to see the investigational PoNS™ Therapy evolve as a potential treatment option for the multitude of patients that have suffered a TBI and are faced with a lifetime of neurologic symptoms,” said Helius CEO, Phil Deschamps. “We look forward to the analysis of results and furthering the clinical foundation of PoNS™ Therapy,” he added.
The TCNL TBI trial is similar in design, subject population and outcome measures to Helius’ ongoing, 120-subject registrational study, however, the Helius trial is a 5-week treatment protocol. To learn more about recruitment opportunities please visit:
http://heliusmedical.com/our-research/clinical-trials
About PoNS™ Therapy
The Portable Neuromodulation Stimulator (PoNS™) is an investigational non-invasive device designed to deliver neurostimulation through the tongue. PoNS™ Therapy combines the use of the device with physical therapy and is currently being evaluated in a multicenter clinical trial for the treatment of balance disorder for subjects with mild to moderate Traumatic Brain Injury.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a medical technology company focused on neurological wellness. Helius seeks to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. Helius intends to file for FDA clearance for the PoNS™ device. For more information, please visit www.heliusmedical.com.
About TCNL
Founded in 1992, the Tactile Communication and Neurorehabilitation Laboratory (TCNL) is located at the University of Wisconsin in Madison. They are a research center that uses the experience of many different areas of science to study the theory and application of applied neuroplasticity, the brain’s ability to reorganize in response to new information, needs, and pathways. The aim of their research is the development of solutions for sensory and motor disorders. Their center has three core areas that form the backbone of their research: neuromodulation, sensory substitution, and electrotactile stimulation. TCNL is administratively part of the UW-Madison Department of Kinesiology.
The Toronto Securities Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
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 (“forward-looking statements”).
All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Such forward-looking statements include, among others, statements regarding ongoing or planned clinical research, expected future development timelines, regulatory approvals, business initiatives and objectives and use of proceeds from financings or other business initiatives.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure of the Company to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators.
The reader is cautioned that assumptions used in the preparation of any forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking statement. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. Risks and uncertainties about the Company’s business are more fully discussed in the Company’s disclosure materials, including the short form prospectus filed in connection with the Offering, its Annual Report on Form 10-K filed with the United States Securities and Exchange Commission and the Canadian securities regulators and which can be obtained from either at www.sec.gov or www.sedar.com.
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.
Corporate and Investor Contact:
Brian Bapty
604-652-3950
bbapty@heliusmedical.com
Helius Medical Technologies
Media Contact:
Becky Kern
914-772-2310
media@heliusmedical.com