Helius Medical Technologies (NASDAQ:HSDT) shares rallied 25% in early trading Tuesday after the company said it had met with the FDA to discuss the development plan for evaluating the effects of its Portable Neuromodulation Stimulator, or PoNS, therapy on gait and balance in stroke survivors.
The medical device developer said its registrational program for the device will involve two controlled studies. Enrollment began for the first study in September. The company also plans to submit real-world evidence to support its application for regulatory approval.
Helius said it plans to submit its application for FDA authorization in early 2025, with approval anticipated the same year.
Helius Medical shares rally 25% on FDA meeting
