NEWTOWN, Pa., June 28, 2018 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, announced today that an important paper, “Gray matter volume changes following Cranial Nerve Non-invasive NeuroModulation in patients with traumatic brain injuries” was presented at the 2018 Joint Annual Meeting for the International Society of Magnetic Resonance in Medicine (ISMRM) and the European Society for Magnetic Resonance in Medicine and Biology (ESMRMB) in Paris, France, which occurred June 16 – 21, 2018. This research from independent investigators demonstrates confirmatory evidence of changes in the brain after PoNS Treatment – the combination of the investigational Portable Neuromodulation Stimulator (PoNS™) medical device that delivers tongue-based neuromodulation, plus physical therapy to address balance disorder after mild- to moderate-traumatic brain injury (mTBI).
In two separate studies investigating PoNS Treatment, a large proportion of subjects with chronic balance disorder after mTBI improved dramatically. At one trial site, a subset of participants underwent sequential magnetic resonance imaging (MRI) to evaluate gray matter volume in areas of the brain associated with balance. In this study, nine of forty-four subjects consented to have multiple MRI scans over the 26 weeks of the study to evaluate changes in brain grey matter volume (GMV). All of these subjects had significant improvements in balance and gait but were chosen randomly.
Dr. Vivek Prabhakaran, Associate Professor of Radiology/Neuroradiology, Director of Functional Neuroimaging, Program Leader of Neuroimaging Research and Principal Investigator at the University of Wisconsin, Madison stated, “We’re excited to report preliminary results showing brain changes in regions involved in balance and gait after using the investigational PoNS device in TBI patients afflicted with balance and gait problems.” Only responders were studied with MRI in this trial, it is therefore unknown whether GMV changes would be seen in non-responders.
Ali Rezai, Executive Chair at West Virginia University Rockefeller Neuroscience Institute, Associate Dean & John D. Rockefeller IV Professor in Neuroscience in Morgantown, WV, and member of Helius’ Scientific Advisory Board stated, “Dr. Prabhakaran and colleagues have provided further evidence that the clinical improvement with the PoNS system can be associated with plasticity and structural changes in the brain.”
“Helius is committed to developing non-invasive therapies to combat the symptoms of neurological disease or trauma. In doing so, we are gratified to see results from the best and brightest carrying out high quality science to validate our findings,” added Philippe Deschamps, Helius’ President, CEO and Chairman. “This work by Dr. Prabhakaran is indicative of our Mission, and there is a lot more to come!”
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 an investigational, non-invasive, medical device.
PoNS Treatment is the first and only tongue-delivered neuromodulation that combines 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 United States Securities and Exchange Commission.
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. Such forward-looking statements include, among others, the expected timing of the company’s planned pre-submission meeting with FDA and the expected timing of the Company’s submission regulatory approval of the PoNS device.
Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects”, “estimate”, “intend” 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 uncertainties associated with the FDA regulatory submission and approval process, the Company’s need to raise additional capital 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 its Annual Report on Form 10-K for the year ended December 31, 2017, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018 and its other filings 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.
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Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA