Release Details

-- PoNS^® devices to be provided to a least five sites in five separate administrative regions within Québec --
-- Government-funded initiative will evaluate the benefits of PoNS Therapy™ when used by patients who have suffered the effects of stroke --

NEWTOWN, Pa., Oct. 12, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that it has received a letter of intent (“LOI”) from the Québec Ministry of Health and Social Services (“MSSS”) for the purchase of 30 Portable Neuromodulation Stimulator (“PoNS®”) devices as part of an initiative to assess the value of using PoNS to treat patients suffering symptoms due to stroke.

“Clinical evidence shows that stroke patients treated with PoNS experience significant improvement in gait and balance as well as a reduced risk of falling,” said Dane Andreeff, Helius’ President and Chief Executive Officer. “We are grateful that a second important Canadian healthcare provider has recognized the potential benefits of PoNS Therapy. A few weeks ago, the University of Montreal placed an order for ten PoNS devices to be used in a research study assessing stroke recovery, and the MSSS’s initiative will allow 30 more patients to benefit from PoNS Therapy through MSSS’s funding. We believe this order will accelerate adoption in Canada and, importantly, provide invaluable therapeutic evidence to support Helius’ ongoing efforts to receive authorization for stroke in the United States.”

The sales of these PoNS devices are expected to commence in the fourth quarter of 2023 and extend through the first quarter of 2024.

About Helius Medical Technologies, Inc. 

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases. The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information visit www.heliusmedical.com.  

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (“PoNS”) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, 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.

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com. 

About the Québec Ministry of Health and Social Services
The mission of the Ministry of Health and Social Services (“MSSS”) is to maintain, improve and restore the health and well-being of the Québec population by making accessible a set of integrated health and social services, thus contributing to the social and economic development of Québec.

The primary role of the MSSS is to ensure the proper functioning of the health and social services system. With a view to improving the health and well-being of the population, the MSSS determines the priorities, orientations and policies that fall within the field, and ensures their application. To carry out its mission, the MSSS relies on a network of establishments and people that offer the vast majority of health and social services to the population of Québec. For more information visit https://www.msss.gouv.qc.ca/en/.

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,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the fulfillment of the LOI with MSSS, the success of the Company’s commercialization efforts, Helius’ ability to receive authorization for stroke in the U.S. and the uses and effectiveness of PoNS and PoNS Therapy.

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 uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, lingering impacts of the COVID-19 pandemic, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s 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, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, 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. 

Investor Relations Contact 
Lisa M. Wilson, In-Site Communications, Inc. 
T: 212-452-2793 
E: lwilson@insitecony.com