NEWTOWN, Pa., Oct. 14, 2020 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (NASDAQ: HSDT) (TSX: HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced a partnership with Breakthrough Health (“Breakthrough”), a Berlin-based technology company. Breakthrough builds privacy-focused applications that empower people living with chronic disease to gather and securely own their healthcare data, with the opportunity to share it to support research.
Together, Helius and Breakthrough will work on a research project to better understand how people living with Multiple Sclerosis (“MS”) in the United States evaluate their therapy options as it relates to treatment of gait deficit due to symptoms of MS, which impacts approximately 50-80% of the MS population, estimated at 1,000,000 individuals.
This research project will be conducted via Breakthrough’s MS companion application (“app”) called Emilyn. Emilyn provides Helius with potential access to a diverse cross-section of the MS population, with over 30,000 MS patients using the app globally, including over 10,000 patients in the United States. The research project will focus on U.S.-based app users who agree to provide their information through an anonymous survey, which will be conducted either via email or an app notification. The results of the research will be used by Helius to continue to develop its PoNS™ device and, pending regulatory clearance, assist launch strategy.
“This partnership with Breakthrough is an important step on the path forward for our Company, as we align in meaningful ways to potentially help MS patients with our PoNS Treatment,” said Dane Andreeff, Interim President and CEO of Helius.
“This is a really exciting partnership for Breakthrough and the MS community,” said Bazil Azmil, CEO of Breakthrough. “80% of the people with MS that we queried indicated they wanted to have the opportunity to take part in research. To be able to work with Helius, and to bring people with MS into the heart of a pioneering therapy’s development is something we’re really proud of.”
The Emilyn app enables people with MS to understand and live with their condition better and also to connect them with scientific research. Uniquely, the app was designed in partnership with over 1,500 people diagnosed with MS. It addresses feedback from the MS community, which indicated that MS patients want to participate in research but found there were significant barriers to doing so. For more information, visit https://emilyn.app/ and https://breakthrough.health.
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 (PoNSTM). For more information, visit www.heliusmedical.com.
About the PoNS™ Device and PoNS Treatment™
The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) 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”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ 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 growth and operational progress, including clinical and regulatory development plans for the PoNS device, potential regulatory clearance of the PoNS device, the success of the Company’s partnership with Breakthrough and the ability of such research to impact the Company’s launch plans.
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 impact of the COVID-19 pandemic, uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements 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, 2019, Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 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.