Helius Medical Technologies Moves Forward with FDA Submission
In an exciting development, Helius Medical Technologies, Inc. (NASDAQ: HSDT) recently announced its submission to the U.S. Food and Drug Administration (FDA) under the 510(k) pathway. This submission seeks to expand the labeling of their innovative PoNS (Portable Neuromodulation Stimulator) device, which focuses on improving gait and balance in patients suffering from chronic stroke symptoms.
Significant Improvements Documented in Clinical Trials
The FDA submission is supported by compelling data from their Stroke Registrational Program (SRP), which showcases PoNS's effectiveness in enhancing gait deficits. Analysis revealed that participants using the PoNS device achieved a statistically significant average improvement of over 5 points on the Functional Gait Assessment (FGA). This enhancement remained noticeable at 12 weeks post-therapy completion, reinforcing the treatment's efficacy.
Comparative Analysis with Control Groups
In contrast, control groups, who were engaged in traditional therapies, exhibited fewer gains—averaging less than 4 points in FGA improvements, pointing to a clear disparity in the outcomes achieved between the two groups. The minimal detectable change for clinically meaningful intervention is considered to be 4.2 points, indicating that the PoNS therapy exceeded this threshold significantly.
“The trials demonstrate the superior effectiveness of PoNS Therapy compared to standard physical therapy for stroke rehabilitation,” stated Dr. Antonella Favit-Van Pelt, Chief Medical Officer at Helius. She emphasized how the gathered data underscores PoNS's role in effectively enabling stroke survivors to enhance their walking capabilities when combined with physical therapy, all while being safe and well-tolerated by participants.
Rigorous Clinical Testing Validation
Helius conducted three well-structured clinical trials across 10 sites with 159 chronic stroke survivors. The studies were designed meticulously to evaluate both the safety and efficacy of the PoNS device alongside routine physical rehabilitation therapy over a 12-week duration. Post-treatment evaluations were also conducted to assess the sustainability of improvements seen in participants.
Empirical Evidence of Efficacy
The primary endpoints focused on gait and balance improvements, measured using the FGA and the Berg Balance Score, among other key secondary endpoints related to fall risk and sustainable effectiveness. The findings confirmed that treatment combining active PoNS stimulation with physical therapy led to an impressive average change in FGA scores—5.37 points compared to only 3.31 points in the control cohort, meeting the Hochberg multiplicity standards and further validating the treatment's success.
Long-term benefits were documented with a notable percentage of participants, approximately 89.7%, achieving the desired durability performance goals, affirming the lasting impact of PoNS therapy on their gait capabilities post-treatment. The risk of falling was also addressed, with a significant resolution observed in the active treatment group compared to controls, showcasing PoNS's holistic impact on recovery.
Fostering Patient Access to Innovative Therapies
“The submission of our 510(k) application represents a significant stride forward for stroke patients seeking to regain their mobility through PoNS Therapy,” remarked Dane Andreeff, CEO of Helius. He expressed pride in the collaborative efforts of the team and gratitude towards the clinicians involved in the trials, while also conveying optimism towards a favorable FDA review outcome that could facilitate broader access to the therapy for those affected by strokes.
The Unique PoNS Device Explained
The PoNS device is a groundbreaking, non-invasive therapy option that delivers neurostimulation orally through a mouthpiece. It is primarily designed for home use in conjunction with physical rehabilitation exercises, making it a versatile addition to traditional stroke recovery paths. The device utilizes mild electrical impulses aimed at the tongue, which has been effective in improving balance and gait functionality.
Commitment to Advancing Neurotechnology
Currently, the PoNS device holds FDA approval for specific conditions, particularly for patients experiencing mild-to-moderate gait deficits resulting from Multiple Sclerosis (MS). Notably, in Canada, it has been approved for additional conditions related to stroke and traumatic brain injuries, showcasing its potential across various clinical uses. Helius Medical Technologies aims to expand its accessibility through strategic partnerships and ongoing clinical research.
Helius is committed to addressing neurologic deficits with its innovative platform, designed to enhance physiologic compensatory mechanisms and promote neuroplasticity - key factors in improving patients' daily lives. The focus remains on ensuring their devices are safe, effective, and readily available for those in need of advanced neurotherapeutic solutions.
Frequently Asked Questions
What is the purpose of the PoNS device?
The PoNS device aims to improve gait and balance in patients with neurologic conditions, particularly stroke survivors.
How was the effectiveness of the PoNS device measured?
Effectiveness was measured using the Functional Gait Assessment, indicating significant improvements over the control group.
What are the potential side effects of using the PoNS device?
Clinical trials confirmed that PoNS is generally safe and well-tolerated, with minimal adverse effects reported.
Who can benefit from PoNS Therapy?
Patients aged 22 and older with gait deficits related to conditions like stroke or MS can benefit from PoNS Therapy.
What are the next steps for Helius Medical Technologies?
Helius is awaiting FDA review for its 510(k) submission while continuing to expand its clinical research and access to the PoNS device.
