GlobeNewswire Inc | Aug 11, 2021 07:05AM EDT

August 11, 2021

NEWTOWN, Pa., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (Helius or the Company), a neurotech company focused on neurological wellness, today announced that the Company has launched a new website: https://ponstreatment.com, created to serve as a resource for U.S.-based patients and physicians. The website is designed to provide both audiences with information on the Companys PoNS Treatment and enable them to connect with Helius to learn more information, ask questions and receive future updates.

We are pleased to expand our online resources for U.S.-based patients and physicians as we prepare to commercialize our PoNS technology during the first quarter of 2022, said Dane Andreeff, President and Chief Executive Officer of Helius. Building on this progress, we look forward to educating and developing relationships with key clinicians, and raising awareness of our recently authorized PoNS device at the patient level, as part of our pre-commercial activities during the second half of this year.

About Helius Medical Technologies, Inc.

Helius Medical Technologies is a neurotech company focused on neurological wellness. The Companys purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brains ability to heal itself. The Companys first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, visitwww.heliusmedical.com.

About the PoNS Device and PoNS Treatment

The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to provide treatment of gait deficit. The PoNS device is indicated for use in the United States as a short term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. It 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 MS, and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. PoNS is an investigational medical device in the European Union (EU) and Australia (AUS). It is currently under premarket review by the AUS Therapeutic Goods Administration.

Investor Relations Contact:

Westwicke on behalf of Helius Medical Technologies, Inc.Jack Powell, Vice Presidentinvestorrelations@heliusmedical.com

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, prepare to, look forward, will, expect, remain, hope and similar expressions. Such forward-looking statements include, among others, statements regarding the Companys future growth and operational progress, including pre-commercial activities for the PoNS device, and expected time to begin commercialization of the PoNS device in U.S.

These statements involve substantial known and unknown risks and uncertainties. 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 Companys expectations include uncertainties associated with the Companys capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, the Companys ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Companys ability to secure contracts with rehabilitation clinics, the Companys ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Companys ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, future clinical trials and the clinical development process, manufacturing and supply chain risks, potential changes to the MCIT program resulting from the 60-day deferral of the program implementation, the product development process and FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the Risk Factors section of the Companys Annual Report on Form 10-K for the year ended December 31, 2020, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2021 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.