On March 4, 2024, Helius Medical Technologies, Inc. (the “Company”) issued a press release announcing that the Centers for Medicare & Medicaid Services (CMS) has assigned Healthcare Common Procedure Coding System (HCPCS) Level II codes to the PoNS controller and PoNS mouthpiece, effective April 1, 2024. In addition, the Company plans to provide CMS additional information to support reimbursement economics ahead of the public meetings expected early this summer and believes there is a reasonable expectation that CMS will then determine a reimbursement amount for each of the PoNS controller and mouthpiece to be effective October 1, 2024.
A press release issued by the Company on March 4, 2024 regarding the assignment of these HCPCS codes is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
Cautionary Disclaimer Statement
Certain statements in this Current Report on Form 8-K are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties. Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, the Company’s plans to provide CMS additional information to support reimbursement economics ahead of the public meetings expected early this summer and the expectation that CMS will then determine a reimbursement amount for each of the PoNS controller and mouthpiece to be effective October 1, 2024.
There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, disruptions in the banking system and financial markets, the effect of macroeconomic conditions and the Company’s ability to access capital markets, the Company’s ability to continue to train physical therapists in the supervision of the use of the PoNS Treatment, the Company’s ability to secure additional contracts with rehabilitation clinics, the Company’s ability to obtain national Medicare coverage and to obtain a reimbursement code so that the PoNS device is covered by Medicare and Medicaid, the Company’s ability to build internal commercial infrastructure, secure state distribution licenses, build a commercial team and build relationships with Key Opinion Leaders, neurology experts and neurorehabilitation centers, market awareness of the PoNS device, availability of funds, manufacturing, labor shortage and supply chain risks, our ability to maintain and enforce our intellectual property rights, clinical trials and the clinical development process, the product development process, the regulatory submission review and approval process, our operating costs and use of cash, and our ability to achieve significant revenues, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com.
The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law.
