NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) announced it has exceeded its initial enrollment target for the stroke registrational program evaluating its Portable Neuromodulation Stimulator (PoNS®). With 128 participants enrolled by December 31, 2024, the program is on track to reach its maximum target of 150 by the end of January 2025.
The program is designed to assess the safety and effectiveness of the PoNS device, a non-invasive therapy aimed at improving balance and gait in stroke survivors. Helius plans to submit for FDA authorization in the second quarter of 2025, with hopes of addressing the needs of more than seven million stroke patients in the U.S. experiencing gait and balance disabilities.
“Gait and balance deficits are the most frequently occurring disability in stroke patients and represent the largest market opportunity for PoNS Therapy®,” said Dane Andreeff, President and CEO of Helius Medical. He further emphasized the company’s commitment to bringing this innovative therapy to the market.
The program includes three core studies, all with consistent designs and endpoints focused on assessing gait and balance improvements as well as risk reduction for falls. These studies have highlighted the PoNS device’s potential, which has already shown success in treating similar deficits in MS patients.
“With maximum target enrollment expected by the end of the month, we are tracking to our goal to submit for stroke authorization in the second quarter of 2025,” said Antonella Favit-Van Pelt, Chief Medical Officer of Helius. She praised the swift enrollment, which significantly outpaced benchmarks for stroke-related device studies.
The PoNS device, already authorized for various indications in Canada, delivers neurostimulation through the tongue and is used in conjunction with physical therapy to improve mobility. The completion of this study and the anticipated FDA submission mark critical milestones in expanding its applications, bringing hope to millions of stroke survivors worldwide.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.