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NEWTOWN, Pa., June 11, 2019 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today reported that a scientific paper entitled Human Translingual Neurostimulation Alters Resting Brain Activity in High-density EEG was published in the latest edition of the peer reviewed Journal of NeuroEngineering and Rehabilitation. An electronic copy of the paper can be accessed online at:
This high-density array electroencephalograph (“EEG”) study of the Portable Neuromodulation Stimulator (PoNS™) demonstrates brain activity changes following exposure to both the high (“HFP”) and low frequency pulse (“LFP”) versions of the PoNS device used in the Company’s traumatic brain injury clinical trials. The EEG study was conducted by the Centre for Neurology Studies at HealthTech Connex in Surrey, British Columbia. The experiment involved 20 healthy individuals participating in a two-week, within-subject, cross-over design that compared 20 minutes of PoNS stimulation between HFP and LFP devices. All participants received both HFP and LFP PoNS stimulation, with EEG measurements before, during and after stimulation. EEG measurements examined frequency and spatial activation changes directly resulting from PoNS stimulation.
“In two clinical trials of 163 participants with balance deficits due to mild-to-moderate traumatic brain injury, investigators combined physical therapy and either HFP or LFP versions of the PoNS to investigate the ability to induce a neuroplastic recovery. Both groups showed improvement in objective measures of balance and gait compared to baseline status. The interpretation was that the recovery was indicative that both versions of the PoNS device delivered a neuromodulating signal. We know that the brain’s underlying neuromodulation response to stimulation is complex and elegant, and we are excited to see the next waves of results to enable us to further understand the effects of the PoNS device through an array of advanced neuroimaging techniques,” said Dr. Ryan D’Arcy, principal author of the study. “The findings of this study are tremendously exciting. In this study, the effects continued both immediately after stimulation and into the following week of the study, after just one twenty-minute session,” added Dr. D’Arcy.
“We are committed to generating additional data to characterize how our PoNS technology works for the benefit of patients, healthcare providers, scientists and regulatory authorities around the world. We are tremendously thankful to Dr. D’Arcy and his team for the work to further elucidate how the PoNS device affects the brain,” 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 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 intended for use as an acute treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury and is to be used in conjunction with physical therapy. The device is limited to prescription use. 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 an EU Notified Body and the AUS Therapeutic Goods Administration. PoNS Treatment™ is currently 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
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 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 March 31, 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.
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