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Helius Medical Technologies, Inc. Initiates Open-Label Study for Registrational Program in Stroke

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Helius Medical Technologies, Inc. initiates an open-label study for its registrational program in stroke, focusing on the use of Portable Neuromodulation Stimulator (PoNS®) for gait and balance deficits in chronic stroke survivors. Enrollment of ten patients at Brooks Rehabilitation marks the beginning of the study, aiming to support U.S. authorization under PoNS's breakthrough designation for stroke.
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The initiation of an open-label study to evaluate the Portable Neuromodulation Stimulator (PoNS) for gait and balance deficits in chronic stroke survivors represents a significant milestone for Helius Medical Technologies. This study is part of a broader registrational program aimed at securing U.S. authorization for PoNS under its breakthrough designation for stroke treatment. The relevance of this research lies in its potential to substantiate the effectiveness of cranial-nerve non-invasive neuromodulation (CN-NINM) delivered by PoNS Therapy, which could have a profound impact on the treatment landscape for stroke rehabilitation.

The involvement of Brooks Rehabilitation, a respected institution in neurorehabilitation and the expertise of Dr. Mark Bowden lend credibility to the study. Furthermore, the reference to 'encouraging early trial results' and 'real-world evidence from Canada' where PoNS is already authorized, suggest a positive trajectory for the technology. However, it's crucial to note that the path to FDA approval is rigorous and the outcome of this study will be a key determinant in the device's future in the U.S. market.

From an investment perspective, the results of this study could significantly influence Helius' stock valuation. A successful trial outcome may lead to increased investor confidence and potential market expansion, while an unfavorable result could pose risks to the company's growth prospects. Stakeholders should closely monitor the progress and outcomes of this study for its potential to alter the company's financial trajectory.

Stroke rehabilitation is a critical area of healthcare with a substantial market due to the high prevalence of stroke survivors facing long-term disabilities. The PoNS device's breakthrough designation indicates that the FDA recognizes its potential to address an unmet medical need. If authorized, PoNS Therapy could capture a significant share of the stroke rehabilitation market, especially considering the limited options currently available for chronic stroke survivors to improve gait and balance.

The strategic decision to conduct an open-label study in the U.S. could facilitate faster enrollment and data collection, expediting the authorization process. However, the healthcare industry is highly regulated and the device's commercial success will depend on not only regulatory approval but also on reimbursement policies, healthcare provider adoption and patient access. The long-term impact on Helius' business will be contingent upon these factors, as well as the device's efficacy and safety profile as demonstrated in the upcoming study results.

Investors should be aware of the competitive landscape and the potential for other innovative treatments to emerge. Additionally, the cost-effectiveness of PoNS Therapy compared to existing treatments will be a critical factor in its adoption. The technology's impact on reducing long-term healthcare costs for stroke survivors could be a compelling value proposition for both healthcare providers and payers.

The use of neuromodulation technologies like PoNS in rehabilitation medicine is a growing field, leveraging the brain's plasticity to aid in recovery from neurological conditions. CN-NINM, as applied through PoNS Therapy, represents a non-pharmacological intervention that could complement existing rehabilitation therapies for stroke survivors. The focus on gait and dynamic balance is particularly relevant, as these are common areas of impairment that significantly affect quality of life and independence post-stroke.

Understanding the mechanism by which PoNS facilitates neurological recovery is crucial for both healthcare professionals and investors. The device's ability to enhance neuroplasticity could be a game-changer in stroke rehabilitation, offering a novel approach to treatment that may be more effective or faster-acting than current methods. The study's design and the involvement of key opinion leaders in the field will be instrumental in validating the technology and establishing its place in clinical practice.

It's also important to consider the potential for broader applications of PoNS Therapy beyond stroke rehabilitation, such as in the treatment of other neurological conditions. Success in the stroke market could pave the way for expansion into new therapeutic areas, diversifying Helius' product portfolio and creating additional revenue streams.

-- Enrollment of at least ten patients at Brooks Rehabilitation will begin this month --
-- Study will evaluate the use of Portable Neuromodulation Stimulator (PoNS®) for gait and balance deficits in chronic stroke survivors --
-- Results will support efforts to achieve U.S. authorization under PoNS’s breakthrough designation for stroke --

NEWTOWN, Pa., March 12, 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, today announced the initiation of an open-label study for its registrational program in stroke. The program was established based on encouraging early trial results as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, and aims to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy®, on gait and dynamic balance in chronic stroke survivors.

Under the direction of Mark Bowden, PT, PhD, Brooks Rehabilitation (“Brooks Rehabilitation”) will be the first site to enroll patients. Brooks Rehabilitation is already a participant site to the Company’s ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”).

“The open-label study will serve as an integral part of our stroke registrational program by bringing the PoNS clinical experience to additional sites in the U.S. We’re thrilled to work with Brooks Rehabilitation and Dr. Bowden, a renowned expert in neurorehabilitation and a key contributor to the international guidelines for stroke rehabilitation, to help move PoNS Therapy one step closer to authorization in the U.S.,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.

“PoNS Therapy has the potential to meaningfully improve the lives of over five million stroke patients affected by walking and balance disability. In joining the MUSC trial and participating to the open label study, Brooks is very excited to be on the cutting edge in testing this promising technology. We are hopeful that PoNS Therapy can have a meaningful therapeutic effect on chronic stroke survivors and I’m excited about Helius’ opportunity to expand the clinical research to other sites,” stated Dr. Bowden.

About Brooks Rehabilitation

For more than 50 years, the nonprofit Brooks Rehabilitation, headquartered in Jacksonville, Fla., has been a comprehensive system of care for physical rehabilitation. Ranked by U.S. News & World Report as the No. 1 rehabilitation hospital in Florida and one of the top 20 in the nation, Brooks operates three inpatient rehabilitation hospitals – two in Jacksonville, Fla., including one of the nation’s largest with 170 beds, and a Center for Inpatient Rehabilitation in partnership with Halifax Health in Daytona Beach, Fla. Brooks also operates one of the region’s largest home healthcare agencies; more than 50 outpatient therapy clinics; a physician practice; Clinical Research Center; two skilled nursing facilities; assisted living and memory care. Brooks also provides many low- or no-cost community programs and services to improve the quality of life for people living with physical disabilities. For more information, visit BrooksRehab.org.

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 the Company’s ability to enroll at least ten patients at the Brooks Rehabilitation Hospital at the beginning of the month, the potential to get U.S. authorization under PoNS’s breakthrough designation for stroke, the results of the open-label study, future decisions and approvals from applicable regulatory entities in the U.S. and Canada, 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, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to continue to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure additional 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 


FAQ

What is the focus of Helius Medical Technologies, Inc.'s open-label study?

The open-label study is focused on the use of Portable Neuromodulation Stimulator (PoNS®) for gait and balance deficits in chronic stroke survivors.

How many patients will be enrolled at Brooks Rehabilitation for the study?

At least ten patients will be enrolled at Brooks Rehabilitation for the study.

What is the goal of the study in terms of U.S. authorization?

The study aims to support U.S. authorization under PoNS's breakthrough designation for stroke.

Who will be leading the enrollment of patients at Brooks Rehabilitation?

Mark Bowden, PT, PhD, will be leading the enrollment of patients at Brooks Rehabilitation.

What is the potential impact of PoNS Therapy on stroke patients?

PoNS Therapy has the potential to improve the lives of over five million stroke patients affected by walking and balance disability.

Helius Medical Technologies, Inc.

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About HSDT

helius medical technologies, inc., a neurotechnology company, focuses on developing, licensing, and acquiring non-invasive technologies for the treatment of symptoms caused by neurological disease or trauma. the company's product is portable neuromodulation stimulator (pons), a medical device in canada for the treatment of chronic balance deficit due to mild-to-moderate traumatic brain injury. its pons device treats neurostimulation of cranial nerves via the tongue to restore lost function. the company is headquartered in newtown, pennsylvania.