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-- Helius Medical and Shepherd Center partner on a study that aims at rehabilitating walking mobility in people recovering from stroke --
-- Shepherd Center, a top neurorehabilitation hospital, is the third site in Helius' U.S. registrational program for Portable Neuromodulation Stimulator (PoNS®) in stroke --
-- The single-arm study will evaluate PoNS in treating gait and balance deficits in chronic stroke survivors --
-- Regulatory submission seeking marketing authorization for stroke expected in 2025--
NEWTOWN, Pa., April 24, 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 expansion of its clinical development program for the broadening of the labeling of its marketed PoNS device to include patients recovering from stroke with the participation of Shepherd Center, under the direction of Michael Yochelson, M.D., MBA, FAAN, FAAPMR, Chief Medical Officer. Participating to the Company-sponsored single-arm study, Shepherd Center joins Brooks Rehabilitation as a third clinical site to the overall registrational program. As one of the nation's top neurorehabilitation hospitals, Shepherd Center is known for its innovation, patient outcomes exceeding the national average, and expertise in providing world-class clinical care for people experiencing the most complex conditions, including stroke, spinal cord and brain injuries, multi-trauma, traumatic amputations, multiple sclerosis, and pain.
The study aims to evaluate the potential benefit of PoNS Therapy® in treating gait and balance deficits in chronic stroke survivors. Shepherd Center has been an impactful participant in the PoNS Therapeutic Experience Program ("PoNSTEP"), a Company-sponsored outcome research clinical trial designed to evaluate the impact of subjects' adherence to PoNS Therapy in people with multiple sclerosis ("MS"), a trial led by Deborah Backus, PT, Ph.D., FACRM, Vice President of Research and Innovation.
"Shepherd Center has been a valuable partner to Helius for almost two years. We are delighted Dr. Yochelson has agreed to contribute to the implementation of our stroke registrational program and undertake the study at Shepherd Center," said Antonella Favit-Van Pelt, M.D., Ph.D., Helius' Chief Medical Officer. "Shepherd Center's earlier involvement with the MS program is a testament to the strength of our clinical program. Dr. Backus and her research team have made an impactful contribution to further demonstrating PoNS Therapy's ability to induce significant and clinically meaningful improvements in gait rehabilitation in MS patients. Clinical evidence with PoNS Therapy has led to a new indication for treatment of gait deficits in stroke patients in Canada as well as highlighted the importance of this therapy in reducing the risk of falling in stroke survivors with gait and/or balance deficits. This study, as part of the broader registrational program, is an important step toward potentially obtaining authorization for treatment of gait deficits in stroke patients in the U.S."
"Innovation is at the core of what we do, and strategic collaboration is critical to advancing rehabilitation medicine and discovering better, more effective ways to deliver care," said Dr. Backus. "From my experience with the therapy, PoNS has the potential to improve the lives of patients suffering from MS, and we believe it can have a meaningful therapeutic effect on chronic stroke survivors as well. I'm excited to bring this innovative treatment to Shepherd Center, where we take a patient-centric approach designed to promote the highest level of functioning possible."
With recruitment starting in May 2024, Dr. Yochelson anticipates enrolling approximately 8-10 participants into the trial by the end of the year.
Posted In: HSDT
