Deans' stroke musings: Helius Medical Technologies (HSDT) Initiates Open-Label Study for Registrational Program in Stroke

Changing stroke rehab and research worldwide now.Time is Brain! trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 523 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

My blog is not to help survivors recover, it is to have the 10 million yearly stroke survivors light fires underneath their doctors, stroke hospitals and stroke researchers to get stroke solved. 100% recovery. The stroke medical world is completely failing at that goal, they don't even have it as a goal. Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It lays out what needs to be done to get stroke survivors closer to 100% recovery. It's quite disgusting that this information is not available from every stroke association and doctors group.

Tuesday, March 12, 2024

Helius Medical Technologies (HSDT) Initiates Open-Label Study for Registrational Program in Stroke

PoNS, short for Portable Neuromodulation Stimulator, is an orally applied therapy delivered by neurostimulation through a mouthpiece connected to a portable controller.

Still don't understand anything about this.

Helius Medical Technologies (HSDT) Initiates Open-Label Study for Registrational Program in Stroke

Helius Medical Technologies, Inc. (Nasdaq: HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the initiation of an open-label study for its registrational program in stroke. The program was established based on encouraging early trial results as well as real-world evidence from Canada, where PoNS is already authorized for treatment of stroke, and aims to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy®, on gait and dynamic balance in chronic stroke survivors.

Under the direction of Mark Bowden, PT, PhD, Brooks Rehabilitation (“Brooks Rehabilitation”) will be the first site to enroll patients. Brooks Rehabilitation is already a participant site to the Company’s ongoing investigator-initiated, placebo-controlled study in stroke, led by Dr. Steven Kautz at the Medical University of South Carolina (“MUSC”).

“The open-label study will serve as an integral part of our stroke registrational program by bringing the PoNS clinical experience to additional sites in the U.S. We’re thrilled to work with Brooks Rehabilitation and Dr. Bowden, a renowned expert in neurorehabilitation and a key contributor to the international guidelines for stroke rehabilitation, to help move PoNS Therapy one step closer to authorization in the U.S.,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer.

“PoNS Therapy has the potential to meaningfully improve the lives of over five million stroke patients affected by walking and balance disability. In joining the MUSC trial and participating to the open label study, Brooks is very excited to be on the cutting edge in testing this promising technology. We are hopeful that PoNS Therapy can have a meaningful therapeutic effect on chronic stroke survivors and I’m excited about Helius’ opportunity to expand the clinical research to other sites,” stated Dr. Bowden.