NEWTOWN, PA - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a medical technology company focused on neurological wellness, announced that the Centers for Medicare and Medicaid Services (CMS) has published the final Medicare payment rates for the company's Portable Neuromodulation Stimulator (PoNS) device.
The rates, which align with preliminary reimbursement determinations, were released on Monday and are now available for the PoNS Controller, identified by HCPCS Code A4593. The announcement comes as the micro-cap company, valued at $2.58 million, faces challenging market conditions with a revenue decline of 36.62% over the last twelve months.
This development represents a significant milestone for Helius, as it solidifies the reimbursement pathway for the PoNS device, potentially expanding access for Medicare beneficiaries. The PoNS device is part of Helius's efforts to provide innovative therapeutic solutions for individuals suffering from neurological symptoms of diseases and trauma.
The official document from CMS, confirming the final fee schedule, was posted on January 13, 2025. The company expects this decision to enhance the commercial viability of the PoNS device, potentially leading to increased adoption and utilization in clinical settings.
The PoNS device has been developed as a non-invasive option to help treat neurological symptoms associated with certain conditions. The finalized payment rates by CMS are crucial for healthcare providers as they determine the cost coverage for patients utilizing the device under Medicare.
Helius Medical Technologies is headquartered in Newtown, Pennsylvania, and has been committed to the advancement of medical devices that support individuals in their neurological health challenges. The company is incorporated in Delaware and is listed on The Nasdaq Stock Market LLC under the ticker symbol HSDT.
In other recent news, Helius Medical Technologies is facing challenges with the Centers for Medicare & Medicaid Services (CMS) over pricing determinations for its Portable Neuromodulation Stimulator (PoNS) device. The neurotech company has requested a reassessment, arguing that the current pricing does not reflect the technology's value. Helius has also been downgraded by Maxim Group due to concerns over these CMS reimbursement rates.
In response to this, the company is preparing to challenge the decision at an upcoming Healthcare Common Procedure Coding System (HCPCS) meeting. Despite these hurdles, preliminary results from Helius's ongoing PoNSTEP study show significant improvement in Dynamic Gait Index scores for multiple sclerosis patients using the PoNS Therapy.
Although the company reported a decrease in total revenue from the previous year and an operating loss, it has extended its financial stability into 2025 due to a successful public offering. Additionally, Helius is preparing for FDA submission for stroke authorization and exploring the expansion of PoNS therapy for traumatic brain injury patients.
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