During the mid-day trading session, Helius Medical Technologies, Inc. (NASDAQ: HSDT) had a notable increase in its stock price. It rose by 14.58% to $8.07. This increasing pattern comes after the corporation reached a significant regulatory milestone.
Helius declared that its talks with the US Food and Drug Administration (FDA) on streamlining its development plan had concluded well. The strategy is to assess how the gait and dynamic balance of chronic stroke survivors are affected by cranial-nerve non-invasive neuromodulation (CN-NINM) through its PoNS Therapy.
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The registrational program devised by Helius comprises two controlled studies. The clinical initiative encompasses a randomized, controlled, double-blinded investigator-initiated trial (IIT) led by Dr. Steven Kautz at the Medical University of South Carolina (MUSC), alongside a Company-sponsored study aiming to enroll about 100 subjects.
Dr. Kautz’s IIT, which commenced enrollment of 60 participants in September 2023, collaborates with Dr. Mark Bowden at Brooks Rehabilitation as a second site. Securing FDA validation for the registrational program and clinical study design marks a significant milestone for Helius.
Adherence to the agency’s expectations not only paves the way for efficient delivery of PoNS Therapy to stroke patients but also facilitates the most effective route towards potential FDA authorization under PoNS’s breakthrough designation for stroke. Helius is steadfast in its mission to enhance access to PoNS Therapy for North American stroke patients grappling with gait and balance deficits.
Recent collaborations with the University of Montreal and the Quebec Ministry of Health aim to assess the health economic benefits of PoNS Therapy in these patients. Helius anticipates that its development strategy will not only alleviate healthcare burden costs but also expedite authorization in the U.S., where an estimated 80% of the seven million stroke patients experience impaired walking.
Helius Medical Technologies’ recent strides in regulatory approval and strategic collaborations underscore its commitment to advancing innovative therapies for stroke patients. The company’s focus on optimizing treatment access and reducing healthcare costs highlights its dedication to addressing critical unmet medical needs. With promising developments in its pipeline, Helius remains poised for further growth and impact in the healthcare landscape.
