Helius Medical Tech (NASDAQ:HSDT) Low Float Trading High Volume following FDA News

February 6, 2024

DENVER, Colo., Feb. 6, 2024 (247marketnews.com)- Helius Medical Technologies, Inc. (NASDAQ:HSDT) stated, this morning, that it concluded its Food and Drug Administration (“FDA”) communication concerning development plan optimization for its stroke program that aims to evaluate the effects of cranial-nerve non-invasive neuromodulation delivered using PoNS Therapy on gait and dynamic balance in chronic stroke survivors. Helius’ registrational program includes two controlled studies.

Helius Medical is trading at $9.51, up $2.47 (+35.09%), on 1.6M premarket shares traded, more than double its reported 652K shares in the float or 709K shares outstanding.

Its 52-week range is $5.69 to $18.70. It’s bouncing off its 30-day low, $6.50, that it hit on Friday.

“Vetting the registrational program and design of our clinical studies with the FDA is an important milestone for Helius and meeting the agency’s expectations will give us the most efficient path to delivering PoNS Therapy to stroke patients,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer. “This development plan, which leverages early study results and real-world evidence from Canada, allows us to streamline the size, timeline, and cost of the registrational program and positions Helius on the best course toward potential FDA authorization under PoNS’s breakthrough designation for stroke.”

“One of our chief objectives is to optimize access to PoNS Therapy for stroke patients suffering from gait and balance deficit in North America. We recently announced collaborations with the University of Montreal and the Quebec Ministry of Health to evaluate the health economic benefits of PoNS Therapy in these patients and hope that our development approach will not only save several millions of dollars in healthcare burden cost but also lead us on the most expedited pathway toward authorization in the U.S., where an estimated 80% of the seven million stroke patients experience impaired walking,” stated Helius’ President and Chief Executive Officer, Dane Andreeff. “We are now targeting regulatory submission by early 2025 with the goal of receiving marketing authorization later in the same year.”

Website: www.heliusmedical.com

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