Helius Medical Technologies, Inc. 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.

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.