Helius Medical announces alignment with FDA on registrational program

Helius Medical Technologies announced that it has concluded its interaction with the U.S. Food and Drug Administration, FDA, on optimizing the development plan for its stroke program which aims to evaluate the effects of cranial-nerve non-invasive neuromodulation, CN-NINM, delivered using PoNS Therapy on gait and dynamic balance in chronic stroke survivors. Helius’ registrational program includes two controlled studies. The clinical program will leverage a randomized, controlled, double blinded investigator-initiated trial, led by Dr. Steven Kautz at the Medical University of South Carolina and a Company-sponsored study to enroll approximately 100 subjects. Dr. Kautz’s IIT began enrollment of 60 participants in September 2023 with the collaboration of Dr. Mark Bowden at Brooks Rehabilitation as a second site. “Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer. “This development plan, which leverages early study results and real-world evidence from Canada, allows us to streamline the size, timeline, and cost of the registrational program and positions Helius on the best course toward potential FDA authorization under PoNS’s breakthrough designation for stroke.”