Helius Medical Technologies achieves key enrollment milestone in stroke study, eyes FDA submission

Helius Medical Technologies Inc., a trailblazer in neurotechnology, has announced significant progress in its stroke registrational program. The company surpassed its initial enrollment target of 90 participants, enrolling 128 individuals by the close of 2024, with plans to reach the full capacity of 150 participants by January 2025. This development highlights the growing demand for innovative rehabilitation solutions for stroke survivors and sets the stage for an anticipated FDA submission in the second quarter of 2025.

With over 7 million Americans living with stroke-related disabilities, Helius’ Portable Neuromodulation Stimulator (PoNS) device offers hope as a groundbreaking therapy to improve mobility and reduce fall risks.

What is PoNS Therapy, and Why Does It Matter?

The Portable Neuromodulation Stimulator (PoNS) is a non-invasive device designed to deliver mild electrical impulses to the tongue, paired with physical rehabilitation exercises. This unique combination promotes neuroplasticity—the brain’s ability to reorganize and adapt—offering a promising solution for patients experiencing chronic gait and balance deficits due to strokes, multiple sclerosis (MS), or traumatic brain injuries (TBIs).

In the United States, the PoNS device is already approved for short-term treatment of gait deficits in MS patients. With this pivotal study, Helius aims to expand its indication to include stroke survivors, addressing a significant unmet need in neurorehabilitation.

How Does the PoNS Device Work?

The PoNS device utilizes a mouthpiece connected to a controller that delivers gentle electrical stimulation to the tongue. These signals activate cranial nerves, triggering neuroplastic responses in the brain. When integrated with supervised therapeutic exercises, this approach can significantly improve mobility and balance.

Authorized for sale in Canada and Australia, PoNS Therapy has shown effectiveness in mitigating gait and balance issues across three primary indications:

• Gait deficits in stroke survivors.
• Chronic balance deficits due to mild-to-moderate TBIs.
• Gait deficits in MS patients.

This innovative therapy has demonstrated measurable outcomes, including a reduction in fall risks and improved mobility, underscoring its potential impact on stroke rehabilitation.

How Is Helius Advancing Stroke Rehabilitation Research?

Helius’ stroke registrational program comprises three well-structured studies designed to evaluate the safety and efficacy of PoNS Therapy:

• MUSC-RCT: A placebo-controlled trial led by researchers at the Medical University of South Carolina and Brooks Rehabilitation.
• HMI-OLS: An open-label study conducted at five neurorehabilitation centers across the U.S.
• HMI-RCT: A randomized, placebo-controlled trial spanning five sites in Canada and the U.S.

These studies collectively aim to establish the device’s effectiveness in improving gait and balance, reducing fall risks, and maintaining therapeutic benefits post-treatment. Initial enrollment began in August 2023, with rapid acceleration throughout 2024.

By December 2024, 128 participants had been randomized across the three trials—surpassing the original target and achieving an exceptional enrollment rate of five participants per site per month, far exceeding industry benchmarks for similar studies.

What Makes This Study Milestone Significant?

Reaching and exceeding enrollment goals underscores the widespread interest in PoNS Therapy among healthcare providers and patients. “Gait and balance impairments are among the most debilitating challenges faced by stroke survivors,” noted Dane Andreeff, President and CEO of Helius Medical Technologies. “Surpassing this milestone demonstrates the demand for innovative therapies and reaffirms our commitment to addressing a critical unmet need.”

Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer, highlighted the program’s exceptional progress. “Completing this enrollment milestone not only validates the clinical relevance of PoNS Therapy but also demonstrates the dedication of our investigators. This achievement positions us to deliver meaningful solutions for stroke survivors.”

What’s Next for Helius Medical Technologies?

Helius is on track to complete data collection and analysis by mid-2025, aligning with its plans to submit for FDA approval for stroke rehabilitation in the second quarter of the year. This pivotal step would mark a significant expansion of PoNS Therapy’s indications, allowing it to benefit millions of stroke survivors in the U.S.

With its focus on addressing neurological disabilities through cutting-edge technology, Helius is poised to become a leader in the neurotech sector, driving advancements in stroke recovery and beyond.