Helius Medical Technologies, Inc. Announces Formation of Multiple Sclerosis Scientific Advisory Board
Helius Medical Technologies has formed a Multiple Sclerosis (MS) Scientific Advisory Board to enhance its U.S. launch strategy for its PoNS technology. The board, comprising nine leading MS experts, will advise on commercial, reimbursement, and market access strategies, focusing on the treatment of gait deficits due to MS. Their objectives include validating the positive effects of neuromodulation, guiding the launch strategy, and reviewing existing clinical data. The PoNS device is currently under FDA review and is not yet available in the U.S.
- Formation of a Scientific Advisory Board with nine MS experts to support U.S. strategy.
- Expertise will help validate the positive effects of PoNS technology in neurorehabilitation.
- Focus on reviewing clinical data and market access strategies enhances potential launch success.
- PoNS device remains investigational in the U.S., delaying commercial availability.
- Dependence on external advisory board for strategic direction may introduce continuity risks.
Leading Multiple Sclerosis Experts to Inform U.S. Launch Planning and Market Access Strategies
NEWTOWN, Pa., Oct. 08, 2020 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced the formation of a Multiple Sclerosis (“MS”) Scientific Advisory Board.
The Helius MS Scientific Advisory Board currently consists of nine esteemed researchers, clinicians and medical doctors with a body of work in MS and neurorehabilitation that follows the continuum of MS care. The main purpose of the Helius Medical MS Scientific Advisory Board is to advise the Company on aspects of its commercial, reimbursement and market access strategies related to the use of its novel PoNS technology for the treatment of MS. They will review and discuss the Company’s existing clinical data, including its real world evidence, as well as its on-going research opportunities. The MS Scientific Advisory Board’s initial goals will also include developing a new foundational scientific message, helping to validate the positive effects of neuromodulation in improved neurorehabilitative care, informing the development of the Company’s planned U.S. launch strategy to the MS community following the receipt of clearance and providing guidance on the Company’s reimbursement and market access strategies.
“The individuals that comprise our MS Scientific Advisory Board represent key expertise along the patient journey,” said Dane Andreeff, Interim President and CEO of Helius. “Their perspective, knowledge and advice will be critical to our efforts to build awareness of how our PoNS technology may enhance neurorehabilitation outcomes.”
“I believe the strength and passion of our newly formed MS Scientific Advisory Board is ideal for guiding Helius as we plan for our next key milestones,” said Dr. Harry Kovelman, Helius’ Vice President of Medical Affairs. “Their deep clinical expertise in treating individuals with gait issues due to Multiple Sclerosis and their knowledge of neurorehabilitation and other modalities to ‘prime the brain’ will be invaluable as we evaluate how to optimize the health economic and patient impact in the U.S.”
The nine members of the Helius MS Scientific Advisory Board include:
- Dr. Deborah Backus, PT, PhD, FACRM, Director, MS Research, Shepherd Center, immediate past president and current Board Member, ACRM
- Dr. Francois Bethoux, MD, Director of Rehabilitation Services at the Cleveland Clinic Mellen Center
- Dr. Michelle Cameron, MD, PT, MCR, Neurologist, Associate Professor, Multiple Sclerosis Center, Oregon Health & Science University
- Dr. Evan T. Cohen, PT, MA, PhD, NCS., Associate Professor, Rehabilitation and Movement Sciences, Rutgers University School of Health Professions
- Dr. Nora Fritz, PT, PhD, Assistant Professor, Department of Health Care Sciences and Department of Neurology, Wayne State University School of Medicine.
- Brian Hutchinson, PT, MSCS, Executive Director, Dignity Health, Multiple Sclerosis Achievement Center
- Dr. Stephen Kanter, PT, DPT, ATC, Director of Rehabilitation Services at the International Multiple Sclerosis Management Practice (IMSMP)
- Dr. Prudence Plummer, PT, PhD, Professor, Department of Physical Therapy in the School of Health and Rehabilitation Sciences at MGH Institute of Health Professions
- Dr. Mandy Rohrig, PT, DPT, MSCS, Can Do Multiple Sclerosis
About Gait Deficit Due to Multiple Sclerosis
Multiple Sclerosis involves an abnormal response of the body’s immune system that attacks the protective myelin sheath that covers nerve fibers and causes communication problems between the brain and the rest of the body. This interference can lead to deficits in a patient’s gait, which is one of the more common symptoms in those afflicted with MS. Physical therapy, including neurorehabilitation, has been shown to help manage this symptom.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. 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 Treatment™
The Portable Neuromodulation Stimulator (PoNS™) 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 multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Mike Piccinino, CFA
443-213-0500
investorrelations@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,” “look forward,” “will” and similar expressions. Such forward-looking statements include, among others, statements regarding the Company’s future clinical and regulatory development plans for the PoNS device and the potential regulatory clearance of the PoNS device, the success of the Company’s planned study, business and commercialization initiatives and objectives, the potential receipt of regulatory clearance of the PoNS device in the United States, the European Union and Australia and the Company’s revenue guidance.
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 the uncertainties associated with clinical trial enrollments and the results of clinical trials, uncertainties associated with the clinical development process and FDA regulatory submission and approval process, including the Company’s capital requirements to achieve its business objectives and other risks detailed from time to time in the filings made by the Company with securities regulators, and including the risks and uncertainties about the Company’s business described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, and Form 10-Q for the quarter ended June 30, 2020 filed on August 12, 2020 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.
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