Helius Medical Technologies Surpasses Enrollment Milestone

Helius Medical Technologies Surpasses Enrollment Milestone

NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ: HSDT), a neurotechnology company, has achieved remarkable results in its stroke registrational program. This initiative is designed to evaluate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) in enhancing balance and gait in stroke survivors. The company's efforts have led to the enrollment of 128 participants, exceeding the initial goal of 90.

Progress in Stroke Registrational Program

Helius Medical Technologies is on a promising trajectory to achieve its target of 150 participants by the end of January 2025. This achievement comes at a time when the company is pushing to prove the efficacy of PoNS, which has garnered attention for its potential to assist over 7 million patients in the U.S. suffering from stroke-related disabilities. Although the stock is trading at approximately $0.75, many analysts believe it may be undervalued, showcasing strong momentum lately.

The PoNS Device Explained

The PoNS device is an innovative therapy that offers a non-invasive treatment option. It functions through a mouthpiece which connects to a controller, delivering neurostimulation directly. Currently approved for short-term treatment of gait deficits associated with multiple sclerosis, this device represents an adjunct to prescribed therapeutic exercise, primarily for patients 22 years and older.

Study Structure and Potential Outcomes

The registrational program consists of three pivotal studies, notably incorporating a randomized placebo-controlled trial (MUSC-RCT) as well as two company-sponsored trials. Such diverse study structures are critical in establishing the effectiveness of PoNS in mitigating fall risks and ensuring durable treatment results.

Enrollment Process and Collaborations

The program's enrollment began in 2023, involving several key medical institutions, including the Medical University of South Carolina. Expanding collaborations with five dedicated U.S. Centers of Excellence for Neurorehabilitation have further propelled the recruitment process, demonstrating the engaging response from medical professionals and communities.

Leadership Insights on Stroke Treatment

Helius Medical Technologies' leadership is actively involved in driving the vision of making PoNS accessible to stroke patients. President and CEO, Dane Andreeff, expressed optimism about the positive effects PoNS could have on millions living with stroke-induced disabilities. Further, Dr. Antonella Favit-Van Pelt, Chief Medical Officer, considers the timely enrollment a significant milestone towards providing innovative therapies.

Financial Health and Challenges Ahead

Looking towards future regulatory pathways, the company is preparing for a crucial FDA submission expected in 2025. However, Helius Medical Technologies faces important financial scrutiny, especially with a reported revenue decline of approximately 36.62% over the past year. Understanding the company’s financial dynamics remains essential for potential investors.

Future Developments and Market Position

Recently, Helius has secured final Medicare payment rates for the PoNS device from the Centers for Medicare and Medicaid Services (CMS), a critical step forward. However, the company has raised concerns that the reimbursement rates do not adequately reflect the value of their technology. This situation has led to challenges, including a downgrade from Maxim Group regarding their financial outlook.

Exciting Research Outcomes and Innovations

Additionally, initial results from ongoing studies, including the PoNSTEP study, hint at promising improvements in gait performance for patients using the PoNS therapy. Helius is exploring the possibility of expanding its therapy over time, potentially benefiting individuals with traumatic brain injury, thus broadening its market impact.

Frequently Asked Questions

What is the goal of the Helius Medical Technologies stroke program?

The program aims to evaluate the safety and effectiveness of the Portable Neuromodulation Stimulator (PoNS) for treating balance and gait deficits in stroke survivors.

How many participants are enrolled in the stroke study?

Helius has enrolled 128 participants thus far, aiming for a maximum of 150 by the end of January 2025.

What challenges is Helius currently facing?

The company is dealing with a notable revenue decline and concerns over Medicare reimbursement rates for its PoNS device.

What is the status of the PoNS device approval?

Helius is preparing for an FDA submission for stroke authorization anticipated in the second quarter of 2025.

How does the PoNS device function?

The PoNS device delivers neurostimulation through a mouthpiece linked to a controller, offering a non-invasive way to assist patients with gait deficits.

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