— A fifth Center of Excellence has been added to the company-sponsored, multicenter, open-label, observational intervention trial to assess the impact of subject adherence.PoNS®Treatment for improvement of walking in multiple sclerosis —
NEWTOWN, Pa., Jan. 10, 2023 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”) is a neurotech company focused on neurological health. company and today announced its addition. to his Therapeutic Experience Program (TEP) at the Center for Neurology in New England, PC (“NCNE”). In this company-sponsored, observational, open-label study designed to evaluate the impact of subject adherence to portable neuromodulatory stimulator (PoNS) therapy in patients with multiple sclerosis (MS), NCNE has partnered with other will join his four Centers of Excellence in The initiative will be led by NCNE’s Director of Medical, Dr. Salvatore Napoli.
“Dr. Napoli and his team are important contributors to our PTAP program and we are pleased that they are participating in the TEP study. An acclaimed medical center known for its high-touch, integrated approach to treating disease, said Helius Chief Antonella Favit-Van Pelt, MD, Ph.D. official.
“It is well established that disease progression can be managed by advanced pharmacological and non-pharmacologic therapeutic interventions in many people suffering from the physical symptoms of multiple sclerosis. It has demonstrated the ability to improve gait and balance in patients and we are excited to include this important treatment in our broad range of high quality neurological care,” said Dr. Napoli. .
About the New England Neurology Center
The Neurology Center of New England is a comprehensive neurocare center dedicated to the diagnosis, care and management of patients with neurological diseases and syndromes. NCNE manages patients with MS, migraine and other headache syndromes, Parkinson’s disease, neurological disorders, seizure disorders and epilepsy, dementia and memory impairment, numbness, spasticity/dystonia, and more.
About the treatment experience program
The Therapeutic Experience Program is a Helius-sponsored, open-label, observational, interventional, multicenter outcomes research trial designed to assess adherence to on-label PoNS therapy to improve gait disturbance in MS patients in a real-world setting. I’m here. This study will assess subject adherence to PoNS therapy, which combines a PoNS device and physical therapy, to better understand the relationship between treatment regimen adherence and therapeutic functional outcomes. The primary endpoint of this study was gait improvement from the end of supervised treatment (Phase 1) to the end of unsupervised treatment (Phase 2) in relation to the subject’s adherence to her PoNS therapy. is maintained. Secondary endpoints were improvement in gait and balance impairment over time, and clinical global impression of change.
The study will be conducted at 10-12 Centers of Excellence in the United States, with an estimated 4 PoNS devices per site. Registration will begin in the fourth quarter of 2022 and will continue until 2023. A total of 50 to 60 of her MS patients are expected to participate in this program.
About Helius Medical Technologies
Helius Medical Technologies is a leading neurotech company in the medical device space focused on neurological disorders, using non-implantable platform technology that amplifies the brain’s compensatory capacity and promotes neuroplasticity. We aim to improve the lives of those we deal with. Our first commercial product is the Portable Neuromodulation Stimulator (PoNS). For more information, please visit www.heliusmedical.com.
About PoNS devices and PoNS therapy
The Portable Neuromodulation Stimulator is an innovative non-surgical medical device that includes a controller and mouthpiece that provides 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 short-term treatment of gait disturbance due to mild to moderate symptoms due to MS, and will be used as an adjunct to a supervised therapeutic exercise program in a 22-year-old patient. The above is prescription only.
PoNS is also licensed for sale in Canada for two indications: Used in conjunction with physical therapy. (ii) used as a short-term treatment (14 weeks) for gait disturbances due to mild and moderate symptoms of MS, combined with physical therapy; PoNS is also licensed for sale in Australia for short-term use by health care professionals as an adjunct to therapeutic exercise programs to improve balance and gait. For more information, please visit www.ponstherapy.com.
Certain statements in this news release are not historical facts and constitute forward-looking statements or forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995 and the Canadian Securities Act. . All statements other than statements of historical fact contained in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by words such as “believe,” “expect,” “continue,” “will,” “goal,” “objective,” or similar expressions. Such forward-looking statements include, among other things, the expected enrollment, patient participation, and other details related to the results of the TEP study, and that a key opinion leader in the management of MS is committed to his PoNS® therapy. Includes statements about the ability to build knowledge and advise. the wider medical community.
There can be no assurance that such statements will prove to be accurate, and actual results and future events may differ materially from those expressed or implied by such statements. Significant factors that could cause our results to differ materially from our expectations include our capital requirements to meet our business goals, the impact of the COVID-19 pandemic, and our ability to train our physical therapists in supervising use. includes the uncertainty associated with our ability to secure contracts with rehabilitation clinics for PoNS treatment; our ability to obtain nationwide Medicare coverage and obtain reimbursement codes so that PoNS devices are covered by Medicare and Medicaid; Our ability to build commercial infrastructure, secure state sales licenses, build commercial teams, build relationships with key opinion leaders, neurological experts and neurorehabilitation centers, and increase market awareness of PoNS devices, Future Clinical Trial and Clinical Development Processes, Manufacturing and Supply Chain Risks, Product Development Processes and FDA Regulatory Submissions section, from time to time, Zion’s review and approval process, other developmental activities, ongoing governmental regulations, and other risks, and its other filings with the U.S. Securities and Exchange Commission and Canadian securities regulators. documents are available at www.sec.gov or www.sedar.com.
Readers are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements contained in this news release are made as of the date of this news release and the Company undertakes no obligation to update any forward-looking statements or that actual results may differ from such statements. We do not undertake any obligation to update any possible reasons. required by law.
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