Business
Helius Medical Technologies, Inc. Completes Site Participation Enrollment for its U.S. Registrational Program in Stroke
-- Inclusion of the top neurorehabilitation centers REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions completes site
About this update from Solana Company
[{"type":"text","content":"-- 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 ...