NEWTOWN, PA — Helius Medical Technologies, Inc., a leader in neurological therapy devices, is broadening its clinical development program to potentially enhance the application of its PoNS device for stroke survivors. This strategic move involves collaboration with Shepherd Center, under the guidance of Michael Yochelson, M.D., MBA, FAAN, FAAPMR. Shepherd Center, recognized for its outstanding neurorehabilitation services and innovative treatment approaches, joins as the third clinical site in Helius’s registrational program aimed at gaining broader authorization for the PoNS device in the United States.
The portable neuromodulation stimulator (PoNS) device, which Helius markets, is designed to assist in treating gait and balance deficits in patients with neurological conditions. The device has already shown promise in Canada, where it received approval for treating gait deficits in stroke survivors. This expansion into the U.S. market represents a significant step for Helius, aiming to offer new hope to chronic stroke survivors grappling with mobility challenges.
The focus of the study at Shepherd Center will be to assess the effectiveness of PoNS Therapy® in enhancing gait and balance among chronic stroke patients. This follows the center’s successful participation in the PoNS Therapeutic Experience Program (PoNSTEP) targeting multiple sclerosis (MS) patients, which showcased the device’s potential in facilitating significant improvements in gait rehabilitation.
Antonella Favit-Van Pelt, M.D., Ph.D., Chief Medical Officer at Helius, expressed enthusiasm about the collaboration with Shepherd Center and the potential impact of this study on the stroke patient community. “Clinical evidence has highlighted the importance of PoNS Therapy in reducing the risk of falling in stroke survivors. This upcoming study is crucial for expanding treatment options for these patients in the U.S.,” said Favit-Van Pelt.
Dr. Deborah Backus, Vice President of Research and Innovation at Shepherd Center, underscored the innovation-driven ethos of both organizations and their commitment to advancing rehabilitation medicine. The collective expertise and patient-centered approach at Shepherd Center are expected to greatly contribute to understanding the efficacy of PoNS Therapy in stroke rehabilitation.
Recruitment for the study is set to begin in May 2024, with Dr. Yochelson aiming to enroll approximately 8-10 participants by year’s end. This phase of the clinical development program marks an important milestone in Helius Medical Technologies’ mission to unlock new pathways to recovery for those affected by neurological conditions, promising a future where advanced therapies like the PoNS device could become a standard part of rehabilitation regimens for stroke survivors across the nation.
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