Remarkable Progress in Stroke Study by Helius Medical Technologies

Helius Medical Technologies Makes Strides in Stroke Research

Helius Medical Technologies, Inc. (NASDAQ: HSDT), a leader in neurotechnology, has taken significant steps forward in its stroke pivotal study, achieving a remarkable enrollment milestone. As of the end of a recent reporting period, 128 participants have enrolled in the study, surpassing the initial goal of 90 participants. This initiative aims to assess the effectiveness of the Portable Neuromodulation Stimulator (PoNS) in enhancing balance and gait among stroke survivors.

Exciting Developments for the Portable Neuromodulation Stimulator

The PoNS device has been designed to deliver cranial-nerve non-invasive neuromodulation therapy, targeted specifically at improving gait and balance issues in chronic stroke patients. The registrational program indicates great promise for the device, with expectations to reach full enrollment of 150 participants by the end of the month. This therapeutic approach is crucial for addressing mobility challenges faced by millions of stroke survivors.

The Market Need for Effective Stroke Rehabilitation

Stroke survivors often deal with debilitating issues, particularly gait and balance deficiencies, which can severely impact their quality of life. Current statistics reveal that over 7 million individuals in the United States live with disabilities resulting from stroke. The opportunity for PoNS therapy to fill a significant gap in stroke rehabilitation is substantial. Dane Andreeff, President and CEO of Helius, noted the potential of PoNS therapy to improve mobility for these patients significantly.

Path to Regulatory Approval

Helius has made significant progress in its regulatory pathway, expecting to submit an application for FDA authorization of the PoNS device for stroke treatment by the second quarter of a future year. Previous FDA Breakthrough Designation for the device positions it favorably for enhanced regulatory attention and faster clearance, assuring a streamlined route towards making this novel therapy accessible to patients.

Research and Enrollment Achievements

The journey to reaching this enrollment milestone has included comprehensive planning and collaboration with research institutions. Significant studies associated with the stroke registrational program include feasibility trials designed to explore the efficacy of PoNS Therapy compared to traditional rehabilitation methods. Helius has received positive feedback from healthcare providers, emphasizing the demand among patients for innovative rehabilitation solutions.

Clinical Trials and Results

The registrational program's design includes multiple clinical trials, each contributing to robust data aimed at validating the PoNS device’s effectiveness. This comprehensive approach not only focuses on gait and balance improvement but also emphasizes reducing the risk of falls—an essential aspect of rehabilitation for stroke patients. Through teamwork among various clinical sites, Helius has successfully randomized a significant number of participants in a short timeframe, reinforcing confidence in PoNS Therapy’s role in today's clinical setting.

Insights on PoNS Therapy and its Impact

The Portable Neuromodulation Stimulator, as an adjunctive therapy to physical rehabilitation, creates new opportunities for patients. The unique design allows patients to incorporate the device into their treatment regimens, making it user-friendly and effective for improving mobility. Helius looks forward to revealing the capabilities of PoNS in enhancing the quality of life for stroke survivors.

Frequently Asked Questions

What is the primary purpose of the PoNS device in stroke rehabilitation?

The PoNS device aims to enhance balance and gait functionality among stroke survivors through cranial-nerve neuromodulation therapy.

How many participants have been enrolled in the stroke pivotal study?

As of the latest reporting, 128 participants have been enrolled, surpassing the original target of 90.

What are the anticipated benefits of PoNS therapy for stroke patients?

PoNS therapy is expected to improve mobility, reduce falls, and enhance overall quality of life for stroke survivors.

When does Helius plan to submit an application for FDA approval?

Helius targets the second quarter of the upcoming year for FDA submission regarding PoNS authorization for stroke use.

Why is this study significant for stroke patients?

This study represents a chance to provide an innovative therapeutic option for millions of stroke patients struggling with mobility deficits.

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