Helius Medical Technologies, Inc. Secures HCPCS Codes for Portable Neuromodulation Stimulator (PoNS®) Mouthpiece and Controller
-- Significant step toward reimbursement for the only medical device approved in the U.S. for treatment of gait deficit due to multiple sclerosis (“MS”) --
-- Proceeds from recent stock issuances through the Company’s At-The-Market (“ATM”) program extends cash runway into the third quarter 2024 --
NEWTOWN, Pa., March 04, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced that the Centers for Medicare & Medicaid Services (“CMS”) has assigned Healthcare Common Procedure Coding System (“HCPCS”) Level II codes A4593, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime” to describe the PoNS controller and A4594, “Neuromodulation stimulator system, adjunct to rehabilitation therapy regime, mouthpiece each” to describe the PoNS mouthpiece. The new HCPCS codes will be effective April 1, 2024.
“PoNS Therapy® is life-changing for people who suffer gait impairment due to MS and we’re pleased that CMS understood the benefits of this innovative treatment by establishing HCPCS codes for both the PoNS mouthpiece and controller. 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. We believe there is a reasonable likelihood that at the public meetings this summer CMS will determine a reimbursement amount for each of the PoNS controller and mouthpiece to take effect on October 1, 2024,” stated Helius’ President and Chief Executive Officer, Dane Andreeff.
“As we pursue widespread reimbursement for PoNS Therapy, we have continued to manage our cash burn. With the recently announced $1.5 million of net proceeds from the sale of shares of our common stock under our ATM program at an average share price of $9.17 per share, our cash runway has been extended 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 as we continue to pursue authorization for stroke in the U.S.,” concluded Andreeff.
PoNS is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from MS and is to be used as an adjunct to a supervised therapeutic exercise program. The Company is also seeking marketing authorization under PoNS’s breakthrough designation for stroke in the United States, where over five million stroke survivors are affected by walking and balance disability. In Canada, PoNS is authorized to treat balance impairment due to MS, stroke and mild-to-moderate traumatic brain injury.
About Helius Medical Technologies, Inc.
