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Helius Medical Technologies, Inc. Comments on the Centers for Medicare & Medicaid Servicesa?? Announcement Regarding New Medicare Coverage Pathway for Breakthrough Medical Devices

NEWTOWN, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (a??Heliusa?? or the a??Companya??), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare & Medicaid Services (a??CMSa??) 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 a??MCIT,a?? for Food and Drug Administration (a??FDAa??)-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.a??Helius is very pleased by CMSa?? commitment to providing Medicare beneficiaries nation-wide with expedited access to new, FDA-designated breakthrough devices, like our PoNS device,a?? said Dane Andreeff, Interim President and Chief Executive Officer of Helius. a??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.a??About Helius Medical Technologies, Inc.Helius Medical Technologies is a neurotech company focused on neurological wellness. The Companya??s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the braina??s ability to heal itself. The Companya??s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visitA www.heliusmedical.com.
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