Summary: Helius Medical Technologies Inc. has surpassed initial enrollment targets for its stroke registrational program evaluating PoNS Therapy, a novel neuromodulation approach to improve gait and balance in stroke patients, aiming for FDA authorization in 2025.
Key Takeaways:
- Strong Enrollment Success: With 128 participants randomized so far, the program is on track to reach its 150-participant target by January 2025, demonstrating strong provider and patient interest.
- Therapeutic Innovation: PoNS Therapy, already FDA-authorized for MS-related gait deficits, shows promise in addressing significant stroke-related mobility challenges with demonstrated safety and efficacy.
- Path to FDA Approval: Helius plans to submit for FDA authorization for stroke in Q2 2025, leveraging data from three rigorous studies to expand PoNS indications.
Helius Medical Technologies Inc., a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced it has completed and far exceeded the initial target enrollment for its stroke registrational study program. With 128 participants randomized to-date, the program is on track to reach the maximum enrollment target of 150 participants by the end of January 2025.
“Gait and balance deficits are the most frequently occurring disability in stroke patients and represent the largest market opportunity for PoNS Therapy,” says 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.”
In 2021, the U.S. Food and Drug Administration granted Breakthrough Designation for PoNS in stroke. Helius has designed and implemented the stroke registrational program to establish the effects of cranial-nerve non-invasive neuromodulation (CN-NINM), delivered using PoNS Therapy, on gait and balance in chronic stroke survivors to support an FDA submission to expand the PoNS device indication to this patient population. The registrational studies also aim to establish PoNS efficacy on decreasing risk of falling and maintaining the therapeutic effect post-treatment.
“Completing enrollment of our registrational program’s studies is a significant step toward providing stroke patients with a new therapeutic tool to improve their mobility. We have shown PoNS is effective in treating gait deficits for MS patients and we are excited to reinforce similar therapeutic benefits to address a dire medical need in this patient population,” says Antonella Favit-Van Pelt, MD, PhD, Helius chief medical officer. “Our ability to enroll this study in a timely manner highlights providers’ interest in PoNS Therapy and demonstrates patients’ demand for impactful rehabilitation therapies. With maximum target enrollment expected by the end of the month, we are tracking to our goal to submit for stroke authorization in the second quarter of 2025.”
In March 2023, the FDA endorsed the stroke registrational program which originally included two initial studies. The first was an investigator-initiated randomized placebo-controlled trial (MUSC-RCT) in approximately 60 subjects, led by Dr Steven Kautz at the Medical University of South Carolina (MUSC) and Dr Mark Bowden at Brooks Rehabilitation. The second study was a company-sponsored open-label study (HMI-OLS), in approximately 30 subjects. In May 2024, Helius added a third company-sponsored randomized placebo-controlled trial (HMI-RCT) across five sites in Canada and the U.S. All three studies shared 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 of the stroke registrational studies started at MUSC for the MUSC-RCT in August 2023 and, at Brooks Rehabilitation, in August 2024. In June 2024, Helius started enrollment of the HMI-OLS at five U.S. Centers of Excellence for Neurorehabilitation including Shepherd Center, MGH-IHP, Rehabologym, Brooks Rehabilitation, and New England Neurological Center. Enrollment continued, with the HMI-RCT, in July 2024 at Neuro-Concept Rehabilitation Center, Neuphysio, Synaptic Health, Bergin Motion in Canada and Rehabologym in the United States.
“By December 31, 2024, we have reached our goal and exceeded our previously communicated target enrollment of 90 subjects, by randomizing 128 participants across the three registrational programs’ studies and we expect to reach our full enrollment of 150 participants in the next couple of weeks. Achieving and exceeding enrollment rate of approximately 5 participants per site per month in such a short timeframe, significantly outperforming the enrollment benchmark for stroke-related medical device studies, is a monumental achievement for Helius,” Dr Favit-Van Pelt continues. “We are grateful to all our investigators for their extraordinary contribution and dedication to make PoNS Therapy available to stroke patients.”
About the PoNS Device and PoNS Therapy
The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller while it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only.
PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy. PoNS 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.
For more information, visit www.ponstherapy.com.
