Helius Medical Technologies, Inc. Completes Site Participation Enrollment for its U.S. Registrational Program in Stroke
Helius Medical Technologies (Nasdaq:HSDT) has completed site participation enrollment for its stroke registrational program in the U.S., incorporating top neurorehabilitation centers such as REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions. The program aims to evaluate the efficacy of PoNS Therapy® on gait and balance in chronic stroke survivors. Additionally, a supporting study has commenced in Canada to aid in Canadian reimbursement and U.S. approval processes. Helius plans to enroll at least 30 patients by Q3 2024 in the U.S. study, with an FDA submission expected in 2025.
The Canadian study, led by Neuro-Concept Rehabilitation Center, aims to enroll 60 subjects by the end of 2024. This multi-center research trial leverages PoNS Therapy's potential to induce neuroplasticity, thereby improving stroke recovery outcomes.
- Completed site participation enrollment for U.S. stroke registrational program.
- Inclusion of top neurorehabilitation centers enhances study credibility.
- PoNS Therapy has shown potential in improving gait and balance for chronic stroke survivors.
- U.S. study aims to enroll at least 30 patients by Q3 2024.
- Supporting study in Canada targets 60 subjects by the end of 2024.
- FDA submission planned for 2025.
- Partnership with leading research and rehabilitation centers bolsters study's significance and potential outcomes.
- U.S. study still in early stages with only enrollment completed.
- No concrete clinical data provided yet on efficacy from ongoing studies.
- Results from the Canadian study are pending and essential for FDA approval.
- Long timeline for study completion and FDA submission may delay potential market impact.
- Dependence on successful regulatory approvals in both U.S. and Canada.
Insights
The completion of site participation enrollment in Helius Medical Technologies' U.S. registrational program for stroke is a significant milestone for the company. This program aims to substantiate the effects of their Portable Neuromodulation Stimulator (PoNS®) Therapy on gait and balance in chronic stroke survivors, leveraging top neurorehabilitation centers in the country.
From a medical research perspective, the participation of leading centers like REHABOLOGYM, NCNE and MGH-IHP adds substantial credibility and depth to the study. These institutions are renowned for their expertise in neurorehabilitation and their involvement enhances the potential for meaningful clinical outcomes. PoNS Therapy's focus on neuroplasticity, or the brain's ability to reorganize and form new neural connections, is promising for stroke recovery, an area with limited effective treatment options.
For retail investors, it’s important to note that the success of this study could pave the way for FDA approval, potentially opening up a significant market. However, clinical trials are inherently risky and outcomes are uncertain. The company's strategy to bolster their U.S. submission with additional data from Canada is a prudent move, yet investors should remain cautious until more concrete results are available.
From a financial standpoint, Helius Medical Technologies' progress in their U.S. registrational program can have profound implications. Achieving enrollment completion is a key step toward FDA submission, projected for 2025. This milestone, if followed by successful trial outcomes and subsequent regulatory approval, could lead to significant revenue growth opportunities for the company.
Investors should consider the potential market size for stroke rehabilitation therapies, which is considerable given the prevalence of stroke and the limited effective treatments currently available. The involvement of leading neurorehabilitation centers enhances the likelihood of a positive trial outcome but does not guarantee it. The additional Canadian study is also a strategic move to support reimbursement and approval efforts, reflecting the company's comprehensive approach to regulatory and commercial strategy.
However, the company is likely incurring considerable expenses related to these trials. Retail investors should monitor Helius' financial health, particularly cash flow and funding sources, to gauge the sustainability of their operations through the trial period. Positive trial results and regulatory approval would be transformative, but there are significant risks until these milestones are achieved.
-- Inclusion of the top neurorehabilitation centers REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions completes site participation enrollment for the U.S. registrational program in stroke --
-- In Canada, an additional study on the use of Portable Neuromodulation Stimulator (PoNS®) Therapy to treat stroke has started to support Canadian reimbursement and U.S. approval for stroke --
NEWTOWN, Pa., June 17, 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 completion of site participation enrollment for its stroke registrational program in the U.S. with the addition of REHABOLOGYM, Neurology Center of New England (NCNE), and MGH Institute of Health Professions (MGH-IHP). The stroke registrational program, which also includes Brooks Rehabilitation and Shepherd Center, is designed 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 Avrielle Rykman Peltz, M.A., OTR/L and Dr. Jay Lombard, D.O., REHABOLOGYM has already enrolled six subjects and expects to reach at least ten patients by early July. NCNE and MGH-IHP joined the study in May and June, respectively, and both sites will begin enrollment in July. Brooks Rehabilitation started enrollment in April with three participants to date while Shepherd Center enrolled two participants in May and expects to add two more by the end of June. Helius anticipates enrolling at least thirty patients into the open label study, across all sites, by the end of the third quarter.
“PoNS Therapy has demonstrated the ability to generate neuroplasticity, essentially rewiring parts of the brain to significantly and meaningfully improve gait and balance in chronic stroke survivors. With the addition of REHABOLOGYM, NCNE, and MGH-IHP, we now have five of the top neurorehabilitation centers in the U.S. participating in our stroke registrational program, which will significantly bolster our FDA submission when we submit for regulatory approval in 2025,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.
“Having spearheaded several research studies on stroke funded by premier public and private medical establishments, Dr. Lombard and I see great potential for PoNS to assist with stroke recovery and are thrilled to partner with Helius on this groundbreaking, multi-center research trial. REHABOLOGYM’s goal is to accelerate the advancement of cutting-edge technologies, especially when they can pair with therapeutic interventions to deliver long-lasting improvements for people affected by neurological conditions and injuries. PoNS Therapy perfectly aligns with our mission, and we believe that together we can help bring new, validated therapies to the neurologically impaired,” said Avrielle Rykman Peltz, M.A., OTR/L, Co-Founder & Chief Operating Officer of REHABOLOGYM.
“Leading research suggests that the brain has significant plasticity, with the ability to establish new pathways after various types of brain injuries including stroke. With the only portable and readily accessible therapy that has the potential to generate neuroplasticity, Helius is leading the way in applying technological breakthroughs at the bedside,” stated Dr. Jay Lombard, D.O., co-investigator at REHABOLOGYM.
The registrational program was established in part based on real-world evidence from Canada, where PoNS is already authorized for treatment of stroke. To support national reimbursement in Canada, Helius has begun an additional study on the use of PoNS Therapy to treat stroke, with the goal of enrolling 60 subjects by the end of 2024 at three centers of excellence for stroke rehabilitation. The study led by Dr. Murielle Grangeon, PhD, Adm., Founder and General Manager, at Neuro-Concept Rehabilitation Center, with the participation of Neuphysio and Synaptic Health, has already received approval by the Institutional Review Boards (IRB). The sites will begin patient enrollment by the end of the month and the results from this study will be part of the data package submission to obtain FDA authorization for stroke in the United States.
About REHABOLOGYM
REHABOLOGYM is a neuro-robotic rehabilitation center utilizing state of the art technologies and comprehensive methodologies for neurological occupational therapy (OT), physical therapy (PT), speech therapy (ST/SLP) and certified personal training (CPT). For more information visit www.rehabologym.com.
About Neurology Center of New England
The Neurology Center of New England is a comprehensive neurological care center devoted to the diagnosis, care and management of patients with neurological diseases and syndromes. NCNE manages patients with conditions such as Multiple Sclerosis, migraine and other headache syndromes, Parkinson’s disease, neuropathy, seizure disorders and epilepsy, dementia and memory disorders, numbness, and spasticity/dystonia. For more information visit www.myneurodr.com.
About MGH Institute of Health Professions
The MGH Institute of Health Professions is a private university focused on the health sciences and located in Boston, Massachusetts. It was founded by Massachusetts General Hospital in 1977 and is accredited by the New England Commission of Higher Education. For more information visit www.mghihp.edu.
About Neuro-Concept Rehabilitation Center
The Neuro-Concept center for neurological rehabilitation and adapted physical conditioning integrates into clinical practice the latest technologies and the advanced expertise of therapists to meet the needs of pediatric, adult and geriatric neurological clients. Based on evidence and neuroplasticity concept, Neuro-Concept has been applying best practices in the rehabilitation of individuals living with a neurological condition. By offering intensive rehabilitation programs to improve recovery and functional independence in daily life, Neuro-Concept is dedicated to putting patient need first. For more information visit www.neuro-concept.ca.
About Neuphysio
Neuphysio is a private rehabilitation company that provides physiotherapy services to persons in London, ON and surrounding areas. Neuphysio offers clinic, in-home and community-based therapy to persons living with injury or disease. With a focus on neurological rehabilitation, vestibular rehabilitation and gait and balance training, the staff at Neuphysio offer world class service and quality of care. Client centered goals are functionally based and aimed at improving mobility, stability and quality of life. For more information visit www.neuphysio.com.
About Synaptic Health
Synaptic provides a comprehensive range of neurorehabilitation services designed to optimize recovery and enhance quality of life. From physiotherapy and occupational therapy to employing cutting-edge rehabilitation methods and technology, Synaptic’s team strives to deliver the highest standard of therapy and is committed to delivering personalized rehab services tailored to the meet the unique needs of each individual. Synaptic extends support to individuals of all ages facing neurological injuries, conditions, and symptoms, regardless of their stage of recovery or whether they have received a formal diagnosis. For more information visit www.synaptichealth.ca.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using an 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 about the PoNS® or Helius Medical Technologies, 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 functions and results of the stroke registrational program and the additional Canadian stroke study, including the timing of enrollment, future regulatory submissions by the Company as well as 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, 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 negotiate reimbursement with other third-party payers, 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
FAQ
What is the purpose of Helius Medical Technologies' registrational program?
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