July 21, 2025 — Helius Medical Technologies (NASDAQ:HSDT) saw its stock soar more than 70% in pre-market trading Monday after reporting strong clinical results for its Portable Neuromodulation Stimulator (PoNS) Stroke Registrational Program (SRP).
The neurotechnology company announced that a double-blind, randomized clinical trial for the PoNS SRP successfully met its primary endpoint. The trial demonstrated the therapy’s effectiveness in improving gait and balance deficits in patients suffering from chronic stroke symptoms. In addition to clinical efficacy, the trial showed a low rate of adverse events and high treatment tolerability.
These positive findings pave the way for Helius to submit its PoNS system to the U.S. Food and Drug Administration (FDA) through the Breakthrough Device Designation pathway — a program designed to expedite the review of technologies that provide more effective treatment for debilitating conditions.
Friday’s gains of just over 6% were eclipsed by Monday’s explosive rally, during which trading volume spiked to nearly 10 million shares — far above the stock’s three-month average of approximately 280,000 shares per day.
Despite the dramatic price movement, HSDT shares remain significantly down over the longer term — having declined more than 98% both year-to-date and over the past 12 months. Still, investors appeared energized by the latest clinical milestone.
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