NEWTOWN, PA — Helius Medical Technologies, Inc. (NASDAQ: HSDT) has filed a 510(k) submission with the U.S. Food and Drug Administration seeking to expand the label of its Portable Neuromodulation Stimulator (PoNS) device to include treatment of gait and balance deficits in patients with chronic stroke symptoms. The filing was supported by data from the company’s Stroke Registrational Program and submitted under PoNS’ current FDA Breakthrough Device Designation.
Clinical trials demonstrated PoNS’ effectiveness in improving gait when combined with physical therapy. Across pivotal studies involving 159 chronic stroke survivors, patients using PoNS achieved a mean improvement of more than five points on the Functional Gait Assessment (FGA), surpassing the threshold for clinical significance. Results were statistically superior to control groups and sustained for at least 12 weeks post-treatment.
“Substantial evidence across the SRP trials supports the superiority of active PoNS Therapy as compared to physical therapy alone,” said Dr. Antonella Favit-Van Pelt, Chief Medical Officer of Helius. “The totality of data confirms PoNS’ therapeutic effect in improving walking disability by enhancing and potentiating the benefit of physical therapy.”
Safety outcomes were favorable, with no treatment-related serious adverse events reported. The trials also measured improvements in balance, fall risk reduction, and durability of effect, all showing positive trends.
CEO Dane Andreeff called the submission a milestone, noting: “Submitting our 510(k) application to the FDA brings the benefits on gait from PoNS Therapy one step closer to stroke patients. We’re optimistic about a positive FDA outcome and the opportunity to support those living with the effects of stroke.”
If approved, the expanded indication would broaden PoNS’ clinical use beyond its current applications, offering stroke survivors a novel, non-invasive therapy to improve mobility and reduce disability.
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