Helius Medical Exceeds Enrollment Target for Pivotal Stroke Study

January 21, 2025

On Track for FDA Submission

DENVER, Colo., Jan 21, 2025 (247marketnews.com)- Helius Medical (NASDAQ: HSDT), a neurotechnology company focused on innovative neuromodulation therapies for balance and gait deficits, has announced it has exceeded its enrollment target for its stroke registrational program. With 128 participants randomized as of December 31, 2024, the program is on track to reach the target of 150 participants by the end of January 2025.

Dane Andreeff, Helius Medical’s President and CEO, stated, “Gait and balance issues are the most common disabilities in stroke survivors, representing the largest market opportunity for PoNS Therapy. We’re thrilled to be advancing toward making PoNS available to the over 7 million stroke survivors in the U.S. living with disability, as we remain on track for FDA authorization in 2025.”

In 2021, the U.S. Food and Drug Administration (FDA) granted Breakthrough Designation for PoNS in the treatment of stroke. Helius has developed a stroke registrational program to evaluate the effects of cranial-nerve non-invasive neuromodulation (CN-NINM) with PoNS Therapy on gait and balance in chronic stroke survivors. This program aims to support an FDA submission for expanding the PoNS device’s indication to include stroke patients. Additionally, the studies will assess PoNS’ efficacy in reducing the risk of falling and maintaining the therapeutic effect after treatment.

Dr. Antonella Favit-Van Pelt, Chief Medical Officer of Helius, commented, “Completing enrollment for our registrational program is a critical step in providing stroke patients with an innovative tool to improve their mobility. PoNS has already demonstrated its effectiveness in treating gait deficits in MS patients, and we’re eager to extend these benefits to stroke survivors facing urgent medical needs. Our ability to enroll participants swiftly shows strong interest from healthcare providers and the growing demand for impactful rehabilitation therapies. With full enrollment expected by the end of the month, we’re on track to submit for stroke authorization by Q2 2025.”

In March 2023, the FDA endorsed Helius’ stroke registrational program, which initially included two studies: a randomized placebo-controlled trial (MUSC-RCT) with approximately 60 subjects led by Dr. Steven Kautz at the Medical University of South Carolina (MUSC) and Dr. Mark Bowden at Brooks Rehabilitation, and a company-sponsored open-label study (HMI-OLS) with around 30 subjects. In May 2024, a third company-sponsored randomized placebo-controlled trial (HMI-RCT) was added across five sites in Canada and the U.S. All three studies share common endpoints, focusing on improvements in gait and balance, as well as secondary outcomes related to the reduction of fall risk and maintaining therapeutic effects 12 weeks post-treatment.

Enrollment for the stroke registrational studies began in August 2023 at MUSC for the MUSC-RCT and at Brooks Rehabilitation in August 2024. In June 2024, Helius started enrolling participants in the HMI-OLS study at five U.S. Centers of Excellence for Neurorehabilitation, including Shepherd Center, MGH-IHP, REHABOLOGYM, Brooks Rehabilitation, and New England Neurological Center. Enrollment for the HMI-RCT study began in July 2024 at additional sites across Canada and the U.S.

Dr. Favit-Van Pelt added, “As of December 31, 2024, we’ve exceeded our target enrollment of 90 participants, randomizing 128 subjects across all three studies. We expect to complete enrollment at the 150-participant target within the next few weeks. Achieving an enrollment rate of approximately 5 participants per site per month is a significant milestone for Helius, far surpassing the typical enrollment benchmarks for stroke-related medical device studies. This achievement is a testament to the dedication of our investigators and our collective commitment to making PoNS Therapy accessible to stroke patients.”

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