Helius Medical Technologies, Inc. (Nasdaq:HSDT) has announced that it has exceeded its initial enrollment target for its stroke registrational program, marking a significant step toward potential FDA authorization of the Portable Neuromodulation Stimulator (PoNS) for stroke rehabilitation. As of December 31, 2024, the program has enrolled 128 participants, surpassing the initial goal of 90, and is on track to reach a maximum enrollment of 150 by the end of January 2025.
PoNS Therapy for Stroke Rehabilitation
The stroke registrational program aims to demonstrate the safety and effectiveness of the PoNS device in improving balance and gait deficits in stroke survivors. The PoNS device delivers cranial-nerve non-invasive neuromodulation (CN-NINM) and is used in conjunction with physical rehabilitation exercises. The company is targeting an FDA submission for stroke authorization in the second quarter of 2025.
"Gait and balance deficits are the most frequently occurring disability in stroke patients and represent the largest market opportunity for PoNS Therapy®," said Dane Andreeff, Helius Medical President and Chief Executive Officer. "We are excited for the opportunity to make PoNS available to the over 7 million patients in the U.S. living with disability from stroke as we remain on target to achieve FDA authorization for stroke in 2025."
Clinical Trial Design and Endpoints
The stroke registrational program includes three studies: an investigator-initiated randomized placebo-controlled trial (MUSC-RCT), a company-sponsored open-label study (HMI-OLS), and a company-sponsored randomized placebo-controlled trial (HMI-RCT). These studies share the same design and endpoints, including primary outcomes on gait and balance improvement, as well as key secondary endpoints with Type 1 error of reduced risk of falling and maintenance of effect at 12 weeks post-treatment.
Enrollment for the studies began in August 2023 and continued through multiple centers in the U.S. and Canada. Antonella Favit-Van Pelt, M.D., Ph.D., Helius Chief Medical Officer, noted that the rapid enrollment rate, exceeding approximately 5 participants per site per month, significantly outperformed the enrollment benchmark for stroke-related medical device studies.
PoNS Device and its Applications
The PoNS device is a non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller. It is used primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device is already indicated in the United States for short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS).
In Canada, PoNS is authorized for sale for three indications: short-term treatment of gait deficit due to mild and moderate symptoms from stroke, chronic balance deficit due to mild-to-moderate traumatic brain injury (mTBI), and gait deficit due to mild and moderate symptoms from MS. It is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait.
Market Opportunity and Future Outlook
The successful completion of the registrational program and potential FDA approval could open a significant market for Helius Medical Technologies, addressing a critical unmet need in stroke rehabilitation. The company's focus on non-invasive neuromodulation therapies positions it at the forefront of innovative treatments for neurological disorders.
