NEWTOWN, Pa., Aug. 28, 2019 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today is providing an update from early Canadian clinical experience with PoNS.
Marcos Rodrigues, Head of Physical Therapy at the Neurotherapy Montreal clinic, which has treated the most patients across Canada has this to say about his clinical experience to date. “Like any intervention, there is going to be some variation in the results patients can achieve. As a physical therapist, my main goal is to make sure my patients get back to their lives. I personally have not seen a treatment program or technology like PoNS. The PoNS device and the way it delivers neuromodulation during physical training is a game changer in my opinion. Neurotherapy Montreal is a state-of-the-art facility that treats several neurological conditions, including mmTBI. We are excited about the potential for PoNS Treatment to help patients who are suffering from chronic balance and gait issues due to mmTBI.”
Overall Clinical Results:
- The first several mild -to-moderate TBI patients that have completed 14 weeks of treatment in Canada are consistent with what we saw in our two randomized clinical trials in mmTBI, one for 5 weeks and one for 14 weeks:
- Patients in Canada are demonstrating the same pattern of positive change, with improvements in balance and gait within the first 2 weeks followed by continued improvement over their total 14 weeks of treatment
- The majority of patients showed improvement in comfortable gait speed, a measure of their ability to walk, with a meaningful clinical difference at the end of treatment
- Mean patient compliance is over 90%, which is also consistent with what we experienced in the clinical trials
- Not all patients who used PoNS got better.
“While we are pleased with the clinical results to date it is important to note that PoNS treatment is not for everyone. We are extremely pleased to have provided hope and, in the majority of patients treated, to help them resume their activities of daily living that were impaired by their balance and gait disorder related to their mild-to-moderate TBI,” said company CEO Phil Deschamps.
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 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.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
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