NEWTOWN, Pa. - Helius Medical Technologies, Inc. (NASDAQ:HSDT), a neurotech company, has achieved a significant milestone with the assignment of new Healthcare Common Procedure Coding System (HCPCS) Level II codes for its Portable Neuromodulation Stimulator (PoNS) device by the Centers for Medicare & Medicaid Services (CMS).
The codes, which will become effective on April 1, 2024, are expected to facilitate the reimbursement process for the PoNS mouthpiece and controller, devices designed to aid in the treatment of gait deficits due to multiple sclerosis (MS).
The HCPCS codes, A4593 for the PoNS controller and A4594 for the mouthpiece, represent a crucial step in the commercialization and accessibility of this innovative treatment.
Helius' President and CEO, Dane Andreeff, expressed optimism about the company's ability to begin negotiating reimbursement with third-party payers using these unique codes. Anticipation is building for the CMS public meetings this summer, where reimbursement amounts for the PoNS devices are expected to be determined, with an effective date of October 1, 2024.
The PoNS device, which is approved in the United States for short-term treatment of gait deficit due to mild-to-moderate MS symptoms, is used in conjunction with a supervised therapeutic exercise program. It is currently available by prescription for patients 22 years and older.
In Canada, the device has been authorized for treating balance impairments due to MS, stroke, and mild-to-moderate traumatic brain injury, and in Australia, it is authorized for short-term use to improve balance and gait as part of a therapeutic exercise program.
Helius also announced that proceeds from recent stock issuances through its At-The-Market (ATM) program have extended the company's cash runway into the third quarter of 2024. This financial update follows the sale of shares of common stock, which netted $1.5 million with an average share price of $9.17 per share.
The company continues to pursue marketing authorization for PoNS in the treatment of stroke in the United States, aiming to address the needs of over five million stroke survivors affected by walking and balance disabilities.
This news article is based on a press release statement from Helius Medical Technologies, Inc.
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