Newtown, PA– June 21, 2016 – Helius Medical Technologies, Inc. (TSX: HSM, HSM.S, OTCQB: HSDT) (“Helius” or the “Company”) is pleased to announce the results of a case series of individuals with advanced symptoms of Multiple Sclerosis (MS) treated with PoNS™ Therapy.
This study was performed at TCNL1, University of Wisconsin, Madison and the data was presented at the 2016, Annual Meeting of the Consortium of Multiple Sclerosis Centers (CMSC).
Six subjects with advanced MS (Expanded Disability Status Scale (EDSS)2 scores ranging from 6.5 to 7.5) were enrolled in a six-month pilot study. Subjects were trained in PoNS™ Therapy which combines use of the prototype PoNS™ device with physical training in balance, gait, movement and postural stability. Results demonstrated improvements in physical, cognitive and quality of life parameters. The demanding training regimen also resulted in significant real life improvements such as re-adopting a walker for community mobility, decreased fatigue, increased independence with daily activities, overcoming physical obstacles at home and increased community access.
“Those with greater functional ability at the beginning of the study (EDSS 6.5-7.0) made the most significant gains but all subjects could be qualified as improved. The intervention shows promise to prolong functional ambulation and independence with daily activity,” said Principal Investigator Mitch Tyler.
In a separate MS Pilot study, sponsored by Helius (see press release November 2, 2015), the average EDSS score of the subjects was 4.5, while the average in this subject pool was 7.0. In applauding the efforts of the TCNL investigators, Helius CEO Phillippe Deschamps noted, “The patients in this study represent a much more challenging cohort and received PoNSTM Therapy for a longer period (6-months vs. 14-weeks), yet compliance remained high. The outcome is very encouraging”.
1) The TCNL is the Tactile Communications and Neurorehabilitation Laboratory at the University of Wisconsin, Madison. The PoNS™ was developed at TCNL and licensed to a Helius subsidiary..
2) EDSS is a measure of MS disease severity where 0=normal and 10=death.
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.
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.
# # #
Helius Medical Technologies
Brian Bapty, +1.604-652-3950
Becky Kern, 914-772-2310