Helius Medical Technologies, Inc. announced that it has concluded its interaction with the U.S. Food and Drug Administration (?FDA?) on optimizing the development plan for its stroke program which aims to evaluate the effects of cranial-nerve non-invasive neuromodulation (?CN-NINM?) delivered using PoNS Therapy® on gait and dynamic balance in chronic stroke survivors. Helius? registrational program includes two controlled studies.

The clinical program will leverage a randomized, controlled, double blinded investigator-initiated trial (?IIT?), led by Dr. Steven Kautz at the Medical University of South Carolina (?MUSC?) and a Company-sponsored study to enroll approximately 100 subjects. Dr. Kautz?s IIT began enrollment of 60 participants in September 2023 with the collaboration of Dr. Mark Bowden at Brooks Rehabilitation as a second site. When evaluated in a real-world evidence (RWE) database analysis of Canadian stroke patients with gait or balance deficit, PoNS Therapy demonstrated a significant and clinically meaningful improvement in gait, averaging a 6.74-point improvement in the functional gait assessment (FGA) score over a 14-wk treatment period (95% CI: 4.85 to 8.63).

Before starting PoNS Therapy, over 93% of patients were considered at risk of falling, as determined by an FGA<23 score at baseline. After a 14-week treatment regimen with PoNS, 28% of patients were no longer at fall risk, a considerable result given that, in routine clinical practice, rehabilitative physical therapy alone decreases the risk of falling in only 1-3% of patients. Across all stroke patients in the database, 69.2% of patients experienced at least a 5-point FGA improvement, which is larger than the 4.2-point minimal detectable change usually seen in stroke patients.

If authorized to treat stroke in the U.S., PoNS would be eligible for coverage under the proposed Transitional Coverage of Emerging Technologies (TCET) pathway, which would expedite Medicare coverage of certain breakthrough devices by allowing manufacturers the opportunity for increased premarket engagement with the Centers for Medicare & Medicaid Services (CMS). Under the new guidelines, qualifying breakthrough designations would have temporary coverage within six months after FDA market authorization. PoNS received breakthrough designations in both multiple sclerosis and stroke in the United States, potentially benefiting, with a new indication, an estimated 90% of stroke patients who are covered by Medicare.