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Helius Announces Positive Outcome of the Portable Neuromodulation Stimulator PoNSĀ® Stroke Registrational Program and Upcoming Submission to FDA Under Breakthrough Designation

Provided By GlobeNewswire

Last update: Jul 21, 2025

NEWTOWN, Pa., July 21, 2025 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (NASDAQ: HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced positive outcome from the PoNS (Portable Neuromodulation Stimulator) Stroke Registrational Program (SRP) supporting a planned FDA submission seeking an indication for gait and balance deficit in patients with chronic symptoms of stroke under the current Breakthrough Device Designation.

Read more at globenewswire.com

HELIUS MEDICAL TECHNOLOGIE-A

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