Helius Medical Technologies Advances FDA Submission
Helius Medical Technologies, Inc. (NASDAQ: HSDT) has taken a significant step by submitting a FDA 510(k) application for the PoNS (Portable Neuromodulation Stimulator) device, aimed at expanding its use for treating gait and balance deficits in individuals suffering from chronic stroke symptoms. The submission is backed by promising data collected from their Stroke Registrational Program (SRP) and leverages the FDA's Breakthrough Device Designation status.
Understanding the PoNS Device and Its Efficacy
The PoNS device is designed to provide non-invasive neurostimulation through a controller connected to a mouthpiece, allowing stroke patients to incorporate it into their home-based physical rehabilitation routines. The treatment focuses on enhancing balance, stability, and overall gait function. Through comprehensive testing across ten sites with 159 chronic stroke patients, the efficacy and safety of PoNS were successfully validated.
Key Findings from Clinical Trials
In analyzing the effectiveness of PoNS, the Functional Gait Assessment (FGA) resulted in a clinically significant improvement exceeding 5 points within the treatment group, compared to less than 4 points in the control group. This significant difference held statistical relevance across all studies observed.
Expert Insights on PoNS Therapy
Dr. Antonella Favit-Van Pelt, Helius' Chief Medical Officer, highlighted the importance of the extensive evidence supporting PoNS. She noted how the findings reiterated the device's superior effectiveness compared to conventional physical therapy for stroke rehabilitation. The combination of PoNS therapy together with physical rehabilitation enhances rehabilitation outcomes and supports walking abilities in stroke survivors.
Durability of Treatment Effects
Patients involved in the studies underwent a 12-week treatment phase, followed by a subsequent 12-week follow-up period. The results demonstrated that not only did active treatment provide improvements, but the effects remained stable post-therapy. Patients exhibited a mean FGA reduction indicative of sustained improvement over time, showcasing PoNS as not just an immediate treatment solution but also a long-term rehabilitation aid.
Looking Ahead: The Future for Stroke Patients
Helius is eager to see how the FDA will respond to this submission, with the hope of officially bringing the benefits of PoNS Therapy to stroke patients. Dane Andreeff, the CEO of Helius, expressed pride in the progress made and gratitude towards the clinicians and researchers who contributed to the trials, acknowledging their collaboration in enhancing patient outcomes.
About Helius Medical Technologies, Inc.
Helius Medical Technologies is dedicated to innovating treatments for neurological deficits through their oral technology platform. The PoNS device, being their first commercial product, has already shown success in improving the lives of those living with neurologic conditions. Helius continues to focus on expanding the therapeutic applications of the PoNS device, aiming to facilitate greater access to this life-changing technology.
Frequently Asked Questions
What is the PoNS device used for?
The PoNS device is primarily used to improve gait and balance deficits in patients with chronic stroke symptoms, serving as an adjunct therapy to physical rehabilitation.
How does the PoNS device work?
The device delivers mild electrical impulses to the tongue to stimulate the brain, which may help in enhancing physiologic responses, thereby improving balance and gait.
What were the findings of the clinical trials for PoNS?
Clinical trials showed significant improvement in gait scores, with participants achieving a mean FGA improvement of more than 5 points compared to standard therapy, which showed less than 4 points.
How is the PoNS therapy administered?
PoNS therapy is administered through a controller connected to a mouthpiece for home use, along with prescribed physical rehabilitation exercises.
What is the company's goal following the FDA submission?
Helius aims to secure FDA approval to make the benefits of PoNS Therapy accessible to stroke patients, potentially improving their quality of life and rehabilitation outcomes.
