Helius Medical Technologies, Inc. Comments on the Centers for Medicare & Medicaid Services’ Announcement Regarding New Medicare Coverage Pathway for Breakthrough Medical Devices
Helius Medical Technologies (Nasdaq:HSDT) responded positively to the Centers for Medicare & Medicaid Services' (CMS) new Medicare Coverage of Innovative Technology (MCIT) pathway established on January 12, 2021. This initiative enables national Medicare coverage for FDA-designated breakthrough devices from the date of market authorization for up to four years. Should Helius secure FDA clearance for its Portable Neuromodulation Stimulator (PoNS), immediate coverage for beneficiaries could enhance access for approximately 60 million Medicare enrollees.
- CMS's MCIT program may provide immediate nationwide coverage for the PoNS device once FDA authorized.
- The MCIT rule potentially allows Helius to secure coverage for up to four years after commercial launch.
- The PoNS device is still under FDA review for de novo classification and is not yet commercially available in the U.S.
- Uncertainties regarding FDA approval timelines and potential challenges in meeting the MCIT requirements could delay coverage.
NEWTOWN, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare & Medicaid Services (“CMS”) on Tuesday, January 12, 2021.
In the press release, CMS stated that it is finalizing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology, or “MCIT,” for Food and Drug Administration (“FDA”)-designated breakthrough medical devices. The MCIT rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and coverage would last for four years. Manufacturers will be able to opt-in to MCIT and choose a start date for coverage anytime within two years from the date of FDA market authorization. To be eligible for coverage through MCIT, the breakthrough device must be used for the FDA approved or cleared indication(s) for use. The press release can be accessed via the following link: https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f.
“Helius is very pleased by CMS’ commitment to providing Medicare beneficiaries nation-wide with expedited access to new, FDA-designated breakthrough devices, like our PoNS device,” said Dane Andreeff, Interim President and Chief Executive Officer of Helius. “If our request for de novo classification and clearance of the PoNS device is granted by the FDA, the new MCIT rule provides the opportunity to potentially obtain immediate, nation-wide Medicare coverage for four years following its commercial launch. We look forward to working with CMS to obtain more information and express our interest in MCIT, with the goal of providing the approximately 60 million Americans enrolled in Medicare with improved access to the PoNS device.”
About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.
About the PoNS™ Device and PoNS Treatment™
The Portable Neuromodulation Stimulator (PoNS™) is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from multiple sclerosis (MS), and chronic balance deficit due to mild-to-moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS™ is an investigational medical device in the United States, the European Union (“EU”), and Australia (“AUS”). The device is currently under review for de novo classification and clearance by the FDA. It is also under premarket review by the AUS Therapeutic Goods Administration. PoNS™ is currently not commercially available in the United States, the European Union or Australia.
Investor Relations Contact:
Westwicke Partners on behalf of Helius Medical Technologies, Inc.
Jack Powell
investorrelations@heliusmedical.com
Cautionary Disclaimer Statement:
Certain statements in this news release 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,” “continue,” “look forward,” “will,” “committed to,” “goal,” “expect,” “remain,” “hope” and similar expressions. Such forward-looking statements include, among others, statements regarding the implementation of the new MCIT rule, the ability of the Company’s PoNS device to be covered by Medicare, the Company’s future growth and operational progress, clinical and regulatory development plans for the PoNS device, and potential regulatory clearance of the PoNS device, including expected timing for the FDA to resume its review of our request for de novo classification and clearance and expected timing for receipt of the FDA’s decision on such request.
These statements involve substantial known and unknown risks and uncertainties. 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 MCIT rule, and the timing on when national Medicare coverage will be provided, whether such coverage would last for four years, whether the Company will be able to opt-in to such coverage, clinical development process and FDA regulatory submission and approval process, including that the Company’s request for de novo classification and clearance may be declined by the FDA, that the FDA is not required to and may not respond to the Company’s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company’s response will be satisfactory to the FDA, whether the FDA will require additional information, whether the Company will be able to provide it in a timely manner and whether such additional information will be satisfactory to the FDA, uncertainties regarding the Company’s capital requirements to achieve its business objectives, the impact of the COVID-19 pandemic, uncertainties associated with future clinical trials and other development activities, and other risks detailed from time to time in the filings made by the Company with securities regulators, including the risks and uncertainties described in the “Risk Factors” sections of the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, Quarterly Report on Form 10-Q for the quarter ended September 30, 2020 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.
The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.
FAQ
What is the significance of the Medicare Coverage of Innovative Technology (MCIT) for Helius Medical Technologies (HSDT)?
How long does the MCIT coverage last for breakthrough devices like PoNS from Helius (HSDT)?
What are the current regulatory status and availability of the PoNS device from Helius (HSDT)?
What potential risks does Helius face regarding the MCIT program and FDA approval for PoNS (HSDT)?
