NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) recently announced the expansion of the previously announced trial in stroke from 12 to 60 patients. This ongoing investigator-initiated study, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”), will evaluate the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy™, on gait and dynamic balance in chronic stroke survivors.
“PoNS is already authorized for stroke in Canada, and patients using PoNS Therapy to treat symptoms have seen significant improvement in gait and a reduced risk of falling. Based on this meaningful data, Helius has welcomed the opportunity to support Dr. Kautz’s stroke study by expanding the sample size from twelve to sixty patients,” said Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer. “This is a significant step toward our efforts to leverage the breakthrough designation granted in August 2021 and pursue approval for stroke in the U.S. in the near future.”
“Improving dynamic balance is critical for reducing stroke-related morbidity, and analysis of real-world evidence from Canada has given us great confidence to open the study to more patients. We are excited to begin enrolling patients next month,” stated Steven Kautz, Ph.D., Chair, Department of Health Sciences and Research, College of Health Professions, MUSC.
The study will be a placebo-controlled experimental design in which stroke survivors will undergo a total of twelve weeks of a gait and balance physical therapy training program, performed both in clinic (four weeks) supervised by a physical therapist trained on PoNS therapy and at home (eight weeks) unsupervised with an individualized gait and balance training regimen. MUSC anticipates enrollment of the sixty participants will begin in August 2023, with expected completion by the end of 2024.