NEWTOWN, PA — Helius Medical Technologies Inc. (Nasdaq: HSDT) has announced a significant milestone in its mission to improve the lives of those suffering from gait impairment due to multiple sclerosis (MS). The Centers for Medicare & Medicaid Services (CMS) has assigned Healthcare Common Procedure Coding System (HCPCS) Level II codes to describe the company’s Portable Neuromodulation Stimulator (PoNS) controller and mouthpiece.
Effective April 1, 2024, the PoNS controller will be coded as A4593, while the PoNS mouthpiece will carry the code A4594. Both are designated as part of a “neuromodulation stimulator system, adjunct to rehabilitation therapy regime.”
The assignment of these codes by CMS is a critical step towards securing reimbursement for the PoNS therapy. “This marks a critical reimbursement and access milestone and provides Helius the ability to begin negotiating reimbursement with third-party payers using these unique HCPCS codes,” said Dane Andreeff, President and CEO of Helius.
The PoNS Therapy, which is used as an adjunct to a supervised therapeutic exercise program, has shown life-changing results for individuals with gait impairment due to MS. The company is also in the process of seeking marketing authorization for the use of PoNS in treating stroke-related walking and balance disability in the U.S., where over five million stroke survivors could potentially benefit from the treatment.
Andreeff also highlighted the company’s financial position, noting that recent net proceeds of $1.5 million from the sale of common stock under their ATM program have extended their cash runway into the third quarter of this year. “Once we establish reimbursement for PoNS, we believe we will be able to expand reimbursement across third-party payers and have a pathway to positive cash flow,” he added.
In Canada, the PoNS therapy is already authorized to treat balance impairment due to MS, stroke, and mild-to-moderate traumatic brain injury. The recent CMS coding decision in the U.S. is an encouraging development for Helius Medical Technologies as it continues its efforts to bring this innovative treatment to a broader patient population.
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