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Helius Medical Technologies Updates on PoNS Device Reimbursement

Helius Medical Technologies Updates on PoNS Device Reimbursement

Helius Medical Technologies' Latest Reimbursement Updates

Helius Medical Technologies, Inc. is making waves with the recent announcements regarding the Centers for Medicare & Medicaid Services (CMS) payment determinations for its Portable Neuromodulation Stimulator (PoNS) Controller and Mouthpiece. As a leader in neurotech, Helius is dedicated to providing innovative solutions for those dealing with significant balance and gait impairments.

CMS Payment Rate for PoNS Mouthpiece

A notable update is the CMS's reimbursement determination for the PoNS Mouthpiece (HCPCS code A4594) set at $2,963.30. This lump-sum payment is a pivotal change that Helius intends to challenge. The company has expressed dissatisfaction with the pricing, which was anticipated to take effect on January 1, 2025. Helius argues that their substantial investment in research and development should reflect more equitable pricing in the market.

Helius' Commitment to Advocacy

Dane Andreeff, President and CEO of Helius, articulated the company’s concerns regarding CMS’s methods for determining these reimbursement rates, particularly for the PoNS Mouthpiece and Controller. The company is preparing to present compelling data to CMS, demonstrating the true value of their technology, which was designated as a Breakthrough Device by the FDA nearly four years ago.

Deferred Determination for PoNS Controller

In conjunction with the reimbursement announcement for the Mouthpiece, CMS has deferred their final determination for the PoNS Controller (HCPCS Code A4593) to the next payment cycle. This decision follows a prior indication that established its preliminary reimbursement rate at a capped payment of $519.80. Helius is critical of this comparison to TENS devices and is staunchly defending its product's unique applications in treating gait deficits.

Upcoming Public Meetings

Helius plans to engage with CMS in upcoming public meetings to argue the distinctions between the PoNS Controller and TENS devices, reinforcing the device's innovative approach to neuromodulation. The community remains focused on the value that the PoNS technology brings to individuals impacted by neurological disorders.

Innovative Therapy for Balance and Gait Deficits

The Portable Neuromodulation Stimulator represents a breakthrough in treating gait and balance issues, especially for patients suffering from multiple sclerosis (MS). The device operates via a mouthpiece linked to a controller, offering neurostimulation to improve physiological functioning in patients undergoing physical rehabilitation.

Positive Outcomes in Clinical Trials

PoNS has demonstrated promising results in terms of gait improvement and reducing fall risk in stroke patients in Canada, where it has received authorization for multiple indications. The therapy addresses several conditions related to traumatic brain injury and MS, showcasing its versatility and efficacy.

Future of Helius Medical Technologies

Looking ahead, Helius Medical Technologies is not only focused on securing fair reimbursement rates but also on expanding its product pipeline. The company’s goal is to enhance the therapeutic landscape for neurological rehabilitation. CEO Dane Andreeff has highlighted the potential growth of revenue as more patients gain access to PoNS, emphasizing the importance of overcoming reimbursement hurdles.

Contact Information for Investors

For further inquiries regarding Helius Medical Technologies and its innovative products, interested parties are encouraged to reach out to Philip Trip Taylor of Gilmartin Group via email. This connection can provide insights into the company’s vision and upcoming initiatives.

Frequently Asked Questions

What is the main focus of Helius Medical Technologies?

Helius Medical Technologies specializes in developing neuromodulation therapies to address balance and gait deficits in patients with neurological conditions.

What updates has CMS provided regarding the PoNS device?

CMS announced a reimbursement rate for the PoNS Mouthpiece and has deferred its decision on the PoNS Controller to the next payment cycle, underlining the complexity of establishing fair payment rates.

How does the PoNS device aid patients?

The PoNS device delivers neurostimulation through a mouthpiece to improve balance and gait, primarily used in conjunction with physical rehabilitation exercises.

What is the anticipated impact of the reimbursement decisions?

Helius believes that securing fair reimbursement rates will enhance patient access to PoNS technology, driving revenue growth and facilitating positive cash flow generation.

Who can I contact for investor relations inquiries?

Investors can reach out to Philip Trip Taylor from Gilmartin Group for any inquiries related to Helius Medical Technologies and their development plans.

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