NEWTOWN, PA — Helius Medical Technologies, Inc. (Nasdaq: HSDT) has announced an expansion of its registrational program with the addition of Brooks Rehabilitation Hospital. This strategic alliance is expected to accelerate the development and clinical testing of Helius’s pioneering PoNS Therapy™.
The initiative, aimed at establishing the effects of cranial-nerve non-invasive neuromodulation (CN-NINM) on gait and dynamic balance in chronic stroke survivors, is seen as a key step in Helius’s pursuit of regulatory approval in the U.S. The company already has authorization for the treatment of stroke in Canada.
Investors are watching this development closely, as it could significantly boost Helius’s market position and provide a new revenue stream. The inclusion of Brooks Rehabilitation Hospital, under the direction of Dr. Mark Bowden, is expected to bring the total number of subjects enrolled in the clinical program to roughly 100.
Helius’s Chief Medical Officer, Dr. Antonella Favit-Van Pelt, highlighted the significance of this collaboration, stating, “The participation of Brooks Rehabilitation marks an important step in the implementation of our clinical program under breakthrough designation for stroke.”
Dr. Bowden expressed his enthusiasm for the project, stating, “We are tremendously excited to be a part of this foundational work using the PoNS device with individuals post-stroke.” He anticipates enrolling approximately 40 participants to the development program at Brooks Rehabilitation starting in January 2024, with full enrollment expected by year-end.
For investors, this development signals a potential game-changer in the medical technology sector. If successful, PoNS Therapy™ could provide a novel therapeutic option for over five million stroke survivors affected by walking and balance disability in the U.S. alone. This could translate into substantial returns for investors and a significant boost to Helius’s market value.
However, as with all clinical trials, there are associated risks. Regulatory hurdles, unforeseen side effects or unsuccessful trial results could potentially impact the expected returns. As such, investors will be keeping a close eye on the progress of this initiative as it unfolds over the coming year.
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