Helius Medical announces further expansion of stroke clinical program

Helius Medical Technologies announced the expansion of the registrational program with the addition of Brooks Rehabilitation Hospital. The program, structured on the basis of encouraging results from an early trial as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, focuses on establishing the effects of cranial-nerve non-invasive neuromodulation, delivered using PoNS Therapy, on gait and dynamic balance in chronic stroke survivors. Brooks Rehabilitation will participate as an adjunct site, under the direction of Dr. Mark Bowden. Dr. Bowden will also take part in additional clinical activities that, when combined with the randomized controlled study, aim to bring the total number of subjects enrolled in the clinical program to approximately 100. “The participation of Brooks Rehabilitation marks an important step in the implementation of our clinical program under breakthrough designation for stroke. Dr. Bowden, with his longstanding leadership and contribution to the field of neurorehabilitation for stroke, brings the expertise needed to execute our registrational program. Data from the clinical development activities will contribute invaluable evidence toward our pursuit of regulatory approval in the U.S., and, if successful, provide an impactful therapeutic option for over five million stroke survivors affected by walking and balance disability,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.