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-- 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.
Posted In: HSDT
