(RTTNews) - Helius Medical Technologies (HSDT), a neurotech company focused on innovative treatments for neurological deficits, on Tuesday announced strong progress in its stroke registrational program, surpassing its initial enrollment target.
As of December 31, 2024, 128 participants have been enrolled, exceeding the initial target of 90 participants.
The study is expected to reach the maximum enrollment of 150 participants by the end of January 2025.
The stroke registrational program is designed to evaluate the safety and effectiveness of PoNS or Portable Neuromodulation Stimulator in improving balance and gait deficits in chronic stroke survivors. The study aims to provide key data for an FDA submission, with the goal of gaining authorization for stroke by the second quarter of 2025.
The program includes three studies: an investigator-initiated randomized placebo-controlled trial, a company-sponsored open-label study, and a new randomized placebo-controlled trial added in May 2024.
The studies assess the impact of PoNS Therapy on gait, balance, and fall risk in stroke patients, using mild electrical impulses delivered through a mouthpiece to stimulate cranial nerves.
Helius received Breakthrough Designation from the FDA for PoNS in stroke in 2021, further solidifying the potential of PoNS Therapy as a novel treatment for improving mobility in stroke patients.
The company remains on track to submit its findings for FDA approval by mid-2025.
Currently, HSDT is trading at $1.41 up by 86.4%.
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