Release Details

PTAP Lowers the Cost of PoNS Therapy™ for Qualified Americans

NEWTOWN, Pa., Jan. 05, 2023 (GLOBE NEWSWIRE) -- Helius Medical Technologies (NASDAQ: HSDT) today announced the extension of a program that puts the company’s Portable Neuromodulation Stimulator (PoNS^®) into the hands of qualified Americans with multiple sclerosis (MS) at a significantly reduced cost.

This initiative, the Patient Therapy Access Program (PTAP), launched in June 2022 and was slated to expire at the end of last year. PTAP is now active until June 30, 2023, reflecting high interest in a program that partially subsidizes PoNS Therapy™ for people with MS who qualify through a proper prescription and letter of medical necessity.

At the center of PoNS Therapy is Helius’s PoNS device, which delivers electrical impulses through nerve fibers on the tongue, stimulating the flow of neural impulses to areas of the brain that control gait. This creates a cascade of activity resulting in neuroplastic changes – essentially “rewiring” parts of the brain associated with walking. When paired with an exercise regimen supervised by a rehabilitation specialist, this activity improves gait impairment in people with MS.

“Helius’s passion is helping people with MS maximize their ability to walk, and we’re excited to make cutting-edge neurotech like PoNS available to more people, more often,” said Helius President and Chief Executive Officer Dane Andreeff. “PTAP brings PoNS to people who otherwise wouldn’t be able to experience its benefits. Extending this program is just one initiative that illustrates our commitment to accessibility.”

People with MS, their healthcare providers and rehabilitation specialists can learn more about PoNS Therapy at www.ponstherapy.com. Information on PTAP can be accessed by clicking the red “GET PoNS” button on the site.

“Our goal is to remove as many barriers to this technology as possible,” Andreeff said. “We hope that people with MS and their caregivers consider whether PoNS is for them and if they qualify for the assistance that PTAP provides. When someone’s gait is impaired the stakes are often too high not to explore every opportunity for improvement.”

About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using non-implantable platform technologies that amplify the brain’s ability to compensate and promote neuroplasticity, improving the lives of people dealing with neurologic diseases.   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 Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers electrical stimulation to the surface of the tongue to improve balance and gait. 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. Helius is advancing PoNS post-approval research in MS through a recently launched Therapeutic Experience Program (TEP).

PoNS is also authorized for sale in Canada for two indications: (i) PoNS is authorized 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 (ii) PoNS is authorized 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 the expected scope and duration of PTAP, patients’ ability to qualify for PTAP and the future development and availability of Helius’ products.

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, and ability to raise capital, the impact of the COVID-19 pandemic, 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, future clinical trials and the clinical development process, manufacturing and supply chain risks, 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 Company’s Annual Report on Form 10-K for the year ended December 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.

Investor Relations Contact

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