Helius Medical Technologies, Inc. Announces Alignment with FDA on Registrational Program for Treatment of Stroke Patients

-- Studies uses Portable Neuromodulation Stimulator (PoNS®) to evaluate cranial-nerve non-invasive neuromodulation for gait/balance deficits in stroke patients --

-- Interaction with FDA on clinical program feasibility streamlines cost and timeline and leverages trials with the Medical University of South Carolina and Brooks Rehabilitation --

-- Studies and real-world evidence results will be submitted for regulatory authorization under PoNS’s breakthrough designation for stroke --

-- Regulatory submission for stroke and marketing authorization expected in 2025 --

NEWTOWN, Pa., Feb. 06, 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, announced today 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 (“IIT”), led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”) 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.”

When evaluated in a real-world evidence (RWE) database analysis of Canadian stroke patients with gait or balance deficit, PoNS Therapy demonstrated a significant and clinically meaningful improvement in gait, averaging a 6.74-point improvement in the functional gait assessment (FGA) score over a 14-wk treatment period (95% CI: 4.85 to 8.63). Before starting PoNS Therapy, over 93% of patients were considered at risk of falling, as determined by an FGA