Shares of Helius Medical Technologies, Inc. (NASDAQ: HSDT) jumped 90.22% to $16.93 in pre-market trading following the company’s announcement of very positive Stroke Registrational Program (SRP) findings.
Breakthrough Clinical Results from PoNS Therapy
Helius Medical, operating under the FDA’s Breakthrough Device Designation, announced positive results from its Portable Neuromodulation Stimulator (PoNS) Stroke Registrational Program.
In stroke patients receiving active PoNS therapy, the program’s main double-blind randomized controlled study demonstrated a statistically significant improvement in gait and balance, meeting its primary aim. Even after integrating data from an open-label research using statistical techniques to balance baseline characteristics, these benefits persisted.
Furthermore, the studies showed acceptable patient acceptability and reported few side effects, supporting the PoNS device’s safety profile.
A Step Forward in Post-Stroke Care
The SRP’s positive outcomes represent a significant advancement for Helius Medical in improving chronic stroke patients’ recovery. According to the business, the results might open up a new treatment option for the more than 7 million Americans who suffer from the long-term consequences of stroke, 80% of whom have severe impairments in their gait and balance.
Later this quarter, Helius plans to submit these data to the FDA for consideration as part of an application for an indication in stroke rehabilitation
Coordinated Multi-Trial Effort Supports FDA Submission
The SRP was launched in March 2024 and consists of two sponsor-initiated pivotal trials: a single-arm study that began in April 2024 and a double-blind, randomized controlled trial. The findings are further supported by another investigator-led research that was started in late 2023 by Drs. Steve Kautz (MUSC) and Mark Bowden (Brooks Rehabilitation).
All three trials were structured with consistent study designs and endpoints to measure improvements in gait and balance after 12 weeks of PoNS therapy.
Path Ahead for Regulatory Review
Under the existing Breakthrough Device Designation, Helius Medical intends to submit to the FDA in Q3 2025. The business is hopeful that these strong clinical findings will speed up regulatory approval and eventually offer significant comfort for stroke survivors, even if the PoNS device is not currently licensed in the United States for stroke-related rehabilitation.
