Release Details

Company Will Highlight Major Milestones on Accessibility and Reimbursement Fronts

NEWTOWN, Pa., May 23, 2024 (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, will exhibit for the third consecutive year at the Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting, where it will spotlight a year of significant progress in making its innovative Portable Neuromodulation Stimulator (PoNS^®) more accessible to people whose multiple sclerosis (MS) has impaired their ability to walk.

CMSC’s 38^th Annual Meeting runs from May 29 to June 1 at the Music City Center in Nashville, TN. Visitors to booth 500 will learn about PoNS – a non-implantable, orally applied, electrical stimulation therapy that, when used in combination with rehabilitative physical exercise, improves gait in people with MS – as well as Helius’ efforts to broaden PoNS’s availability.

“From the beginning, we have prioritized getting PoNS to as many people with MS and gait deficit as possible. We have been actively meeting and negotiating with insurers and others with the goal of increasing accessibility even before PoNS was commercially available,” said Helius Chief Executive Officer Dane Andreeff. “The hard work is paying off, and our achievements over the past two months, in particular, have fueled real momentum. We’re eager to share the latest good news about PoNS and its availability with visitors to our booth.”

Helius’s ability to make PoNS more accessible reflects three significant recent events:

• In March, the Centers for Medicare & Medicaid Services (CMS) assigned Healthcare Common Procedure Coding System (HCPCS) codes covering the PoNS controller and mouthpiece, an important milestone in obtaining reimbursement through Medicare. Following public meetings held at the end of May, CMS will make its final decision on pricing, which will be effective October 1, 2024.
• In April, Helius partnered with Lovell Government Services to make PoNS available to the U.S. Department of Veterans Affairs (VA) – the largest integrated healthcare system in the United States, and home to a network of Multiple Sclerosis Centers of Excellence – the U.S. Department of Defense, and other federal healthcare providers.
• Helius also has trained a critical mass of physical therapists, who design the customized exercise regimens that are an integral part of PoNS Therapy^®. Having more physical therapists on the ground around the country, including the 10 states where MS is most prevalent, makes it easier for people with MS to access a partner near their home.
  

“Each of these achievements represents a win in terms of facilitating access to a technology that makes a meaningful difference in their fight against this common but devastating symptom of MS,” Andreeff said. “Taken together, they represent important progress in removing barriers that keep people with MS from walking better and doing the things they enjoy most. Removing those barriers and helping more people benefit from PoNS has been our goal since the start.”

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. 

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 Helius’ participation in the upcoming CMSC conference, the development, commercialization and success of the Company’s PoNS and PoNS Therapy, 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, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and to obtain a reimbursement code, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the 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 Company’s Annual Report on Form 10-K for the year ended December 31, 2023, 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