Helius Medical ($HSDT) PoNS Trial Shows Promise for Stroke Gait Deficits

Helius Medical Technologies, Inc. (HSDT) announced a positive outcome from the PoNS Stroke Registrational Program supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation.

A double-blind randomized clinical trial conducted by PoNS Technologies Inc. met the primary endpoint by demonstrating statistically significant greater improvements in gait and/or balance deficit due to stroke with active PoNS therapy. This result was achieved both with and without incorporating additional data from an open label study, using statistical methods to balance baseline characteristics.

Helius Technologies initiated the SRP in March 2024 following a positive interaction with the FDA regarding the data development program, study design, and endpoints.

Antonella Favit-Van Pelt, M.D., Ph.D., Chief Medical Officer of Helius Medical Technologies, stated, “The successful execution of the PoNS SRP and the positive results of the clinical trials mark an important milestone in advancing the standard of care for stroke and offer individuals suffering from gait/balance disability a meaningful therapeutic option to rehabilitate and regain their functionality.”