{"id":417623,"date":"2021-01-20T07:08:14","date_gmt":"2021-01-20T12:08:14","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=417623"},"modified":"2021-01-20T07:08:14","modified_gmt":"2021-01-20T12:08:14","slug":"helius-medical-technologies-inc-comments-on-the-centers-for-medicare-medicaid-services-announcement-regarding-new-medicare-coverage-pathway-for-breakthrough-medical-devices","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/helius-medical-technologies-inc-comments-on-the-centers-for-medicare-medicaid-services-announcement-regarding-new-medicare-coverage-pathway-for-breakthrough-medical-devices\/","title":{"rendered":"Helius Medical Technologies, Inc. Comments on the Centers for Medicare &amp; Medicaid Services\u2019 Announcement Regarding New Medicare Coverage Pathway for Breakthrough Medical Devices"},"content":{"rendered":"<div class=\"mw_release\">\n<p align=\"left\">NEWTOWN, Pa., Jan.  20, 2021  (GLOBE NEWSWIRE) &#8212; Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (\u201cHelius\u201d or the \u201cCompany\u201d), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare &amp; Medicaid Services (\u201cCMS\u201d) on Tuesday, January 12, 2021.<\/p>\n<p>In the press release, CMS stated that it is finalizing a new Medicare coverage pathway, Medicare Coverage of Innovative Technology, or \u201cMCIT,\u201d for Food and Drug Administration (\u201cFDA\u201d)-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: <a href=\"https:\/\/www.globenewswire.com\/Tracker?data=68MPQ3xPHTnzy4xRmK2AEfoAG5iFcIK6efZyAAhCGAIHK82fdqqIihyB9iFva9bwcMJrMHfDhm4UvN7ZriFr-oJHqvZoqz-Pop-u01bAV3odhKHLd_nV0PT559cT4GDaMi00ANAfy5_D1QkUjRlLQ2I8Zd7e28r0yEjotR4cSGuFyx_Od6biIUo12GUT0hMvVbEymWQXZdnZ3uel6RjrlVpGM-ClGXyIKsGZRYUjb9uN9BkrKDBaPVKBnBQoT6uM3m3BhOFYjaNrvfx08gFGww==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">https:\/\/www.cms.gov\/newsroom\/fact-sheets\/medicare-coverage-innovative-technology-cms-3372-f<\/a>.<\/p>\n<p>\u201cHelius is very pleased by CMS\u2019 commitment to providing Medicare beneficiaries nation-wide with expedited access to new, FDA-designated breakthrough devices, like our PoNS device,\u201d said Dane Andreeff, Interim President and Chief Executive Officer of Helius. \u201cIf 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.\u201d<\/p>\n<p>\n        <strong>About Helius Medical Technologies, Inc.<\/strong>\n      <\/p>\n<p>Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company\u2019s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain\u2019s ability to heal itself. The Company\u2019s first commercial product is the Portable Neuromodulation Stimulator (PoNS<sup>TM<\/sup>). For more information, visit\u00a0<a href=\"https:\/\/www.globenewswire.com\/Tracker?data=ThH9dR_QYfR0OON9wWALlt_khVQBBfECyukhTuGPL_mOHCzcQyhcnTxTF1d0kUWPQFvS6U9QGkri5UO8XJh8E54VSAP8-C3047HWNeauV1E=\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">www.heliusmedical.com<\/a>.<\/p>\n<p>\n        <strong>About the PoNS\u2122 Device and PoNS Treatment\u2122<\/strong>\n      <\/p>\n<p>The Portable Neuromodulation Stimulator (PoNS\u2122) 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\u2122 is an investigational medical device in the United States, the European Union (\u201cEU\u201d), and Australia (\u201cAUS\u201d). 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\u2122 is currently not commercially available in the United States, the European Union or Australia.<\/p>\n<p>\n        <strong>Investor Relations Contact:<\/strong>\n      <\/p>\n<p>Westwicke Partners on behalf of Helius Medical Technologies, Inc.<br \/>Jack Powell<br \/><a href=\"https:\/\/www.globenewswire.com\/Tracker?data=c7gREE92nb4KAi4MF_x91DnRXyTwfHKfW8OAYfuvngig-zl_cEuH0eq0QQePfQ6_sFgLvEBnbAKnb2RHCOodqFTFWhb9bCUT01R_jGHzHh-XqcEtM-V-xUG-VbVXcCOjIZSWweJo-JVuLL8gU_tCFw==\" rel=\"nofollow noopener noreferrer\" target=\"_blank\">investorrelations@heliusmedical.com<\/a><\/p>\n<p>\n        <strong>Cautionary Disclaimer Statement:\u00a0<\/strong>\n      <\/p>\n<p>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 \u201cbelieve,\u201d \u201ccontinue,\u201d \u201clook forward,\u201d \u201cwill,\u201d \u201ccommitted to,\u201d \u201cgoal,\u201d \u201cexpect,\u201d \u201cremain,\u201d \u201chope\u201d and similar expressions. Such forward-looking statements include, among others, statements regarding the implementation of the new MCIT rule, the ability of the Company\u2019s PoNS device to be covered by Medicare, the Company\u2019s 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\u2019s decision on such request.<\/p>\n<p>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\u2019s 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\u2019s 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\u2019s request in the timeframe indicated by its de novo review goals or in the time the Company expects, whether the Company\u2019s 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\u2019s 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 \u201cRisk Factors\u201d sections of the Company\u2019s 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.<\/p>\n<p>The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of the content of this news release.<\/p>\n<p>      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/www.globenewswire.com\/newsroom\/ti?nf=ODEzODM0NiMzOTM2MTA1IzIwODIwMzE=\" width=\"1\" height=\"1\" \/><br \/>\n      <br \/>\n      <img loading=\"lazy\" decoding=\"async\" class=\"__GNW8366DE3E__IMG\" src=\"https:\/\/ml.globenewswire.com\/release\/track\/03a1ac60-40d8-447c-b5eb-dc0ecdcf1245\" width=\"1\" height=\"1\" \/>\n    <\/div>\n<div class=\"mw_contactinfo\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>NEWTOWN, Pa., Jan. 20, 2021 (GLOBE NEWSWIRE) &#8212; Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (\u201cHelius\u201d or the \u201cCompany\u201d), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare &amp; Medicaid Services (\u201cCMS\u201d) 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 \u201cMCIT,\u201d for Food and Drug Administration (\u201cFDA\u201d)-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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/helius-medical-technologies-inc-comments-on-the-centers-for-medicare-medicaid-services-announcement-regarding-new-medicare-coverage-pathway-for-breakthrough-medical-devices\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;Helius Medical Technologies, Inc. Comments on the Centers for Medicare &amp; Medicaid Services\u2019 Announcement Regarding New Medicare Coverage Pathway for Breakthrough Medical Devices&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-417623","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Helius Medical Technologies, Inc. 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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 &hellip; Continue reading &quot;Helius Medical Technologies, Inc. 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(Nasdaq:HSDT) (TSX:HSM) (\u201cHelius\u201d or the \u201cCompany\u201d), a neurotech company focused on neurological wellness, today provided comments in response to a press release issued by the Centers for Medicare &amp; Medicaid Services (\u201cCMS\u201d) 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 \u201cMCIT,\u201d for Food and Drug Administration (\u201cFDA\u201d)-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 &hellip; Continue reading \"Helius Medical Technologies, Inc. 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