Helius Medical Completes Enrollment for U.S. Stroke Therapy Program

Helius Medical Technologies

NEWTOWN, PAHelius Medical Technologies, Inc. (Nasdaq: HSDT) announced the completion of site participation enrollment for its U.S. stroke registrational program. Newly added participants include REHABOLOGYM, Neurology Center of New England (NCNE), and MGH Institute of Health Professions (MGH-IHP). These institutions join Brooks Rehabilitation and Shepherd Center in a study aimed at evaluating the effects of cranial-nerve non-invasive neuromodulation (CN-NINM) using PoNS Therapy® on gait and balance in chronic stroke survivors.

REHABOLOGYM, under Avrielle Rykman Peltz, M.A., OTR/L, and Dr. Jay Lombard, D.O., has already enrolled six subjects and aims to reach ten by early July. NCNE and MGH-IHP, which joined in May and June respectively, will begin their enrollment in July. Meanwhile, Brooks Rehabilitation started its enrollment in April with three participants, and Shepherd Center began in May with two participants. Helius plans to enroll at least thirty patients across all sites by the end of the third quarter.

“PoNS Therapy has shown promise in generating neuroplasticity, essentially rewiring parts of the brain to improve gait and balance in chronic stroke survivors,” said Dr. Antonella Favit-Van Pelt, Chief Medical Officer of Helius. “With the inclusion of these top neurorehabilitation centers, our program will significantly bolster our FDA submission for regulatory approval in 2025.”

Analysis: The Potential Impact of PoNS Therapy

The addition of these prominent neurorehabilitation centers is a strategic move for Helius. By involving well-known institutions like REHABOLOGYM and MGH-IHP, the study gains credibility and robust data, essential for FDA approval.

PoNS Therapy’s ability to generate neuroplasticity could be transformative for stroke recovery. Neuroplasticity involves the brain’s ability to reorganize itself by forming new neural connections. This can be crucial for stroke survivors who often suffer from persistent gait and balance issues. If this therapy proves effective, it could become a vital tool in stroke rehabilitation, offering new hope to millions affected by such neurological damage.

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Avrielle Rykman Peltz emphasized the importance of accelerating advancements in neurological therapies. “REHABOLOGYM aims to advance cutting-edge technologies that can pair with therapeutic interventions to deliver lasting improvements,” she said. PoNS Therapy aligns perfectly with this mission, providing a potential breakthrough in the treatment of neurological conditions and injuries.

Advancing Stroke Rehabilitation

The registrational program in the U.S. is based partly on real-world evidence from Canada, where PoNS Therapy is already authorized for stroke treatment. Helius has initiated an additional study in Canada to support national reimbursement. This study aims to enroll 60 subjects by the end of 2024 and is being conducted at three centers of excellence for stroke rehabilitation.

The success of these programs could have far-reaching implications. If PoNS Therapy receives FDA approval, it may set a new standard in stroke rehabilitation. This would not only improve patient outcomes but also reduce healthcare costs associated with long-term stroke care.

In conclusion, Helius Medical Technologies is making significant strides in stroke rehabilitation with its PoNS Therapy. The completion of site participation enrollment for its U.S. registrational program marks a critical step towards potentially groundbreaking advancements in treating chronic stroke survivors.

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