DENVER, NC / September 26, 2019 / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB: CRRVF) (“CVR Medical“) a Canadian listed and US based healthcare company in the medical device sector has announced that it has directed a key supplier, CVR Global, to withdraw the January 2019 De Novo submission (the “Submission“) for the Carotid Stenotic Scan device (the “CSS“) from the US Food and Drug Administration (the “FDA“). Management of CVR Medical directed CVR Global to withdraw the Submission due to capital constraints arising from, among other things, a cease trade order (the “CTO“) issued by the British Columbia Securities Commission (the “BCSC“). The CTO was issued due to, among other things, the delayed submission of CVR Medical’s fiscal year 2018 financial audit (the “Audit“). CVR Medical has submitted the Audit and is currently working with the BCSC to revoke the CTO as soon as possible. CVR Medical expects trading to resume, which will provide liquidity and allow CVR Medical to accelerate its efforts to submit a new De Novo submission to the FDA. CVR continues to collect clinical data and will ramp collection as capital allows, with the intention to re-submit Q1 2020.
About CVR Medical
CVR Medical is a healthcare company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary technology, the CSS. The CSS is a diagnostic tool that encompasses subsonic, infrasonic, and low frequency sound wave analysis technology. The CSS is a patented device designed to detect and measure carotid arterial stenosis. CVR is currently conducting clinical trials at leading institutions and has submitted the CSS to the FDA as a De Novo application. CVR is led by an experienced and proven team of professionals with extensive healthcare, medical device, international expansion, regulatory and sales experience. On many developmental, regulatory, and manufacturing aspects of the project CVR Medical works in unison with CVR Global Inc. and the abbreviation “CVR” is used in describing the collaboration. CVR Medical trades on the TSX Venture Exchange under the symbol “CVM” and on the OTCQX under the symbol “CRRVF”. Additional information regarding the Company can be found in our recent filings with the SEDAR as well as the information maintained on our website at www.cvrmed.com
ON BEHALF OF THE BOARD:
(signed) “Peter Bakema”
CEO, President & Director
For further information contact:
Peter Bakema, CEO, President and Director
This press release contains forward-looking information that involves various risks and uncertainties regarding future events related to the re-submission of the FDA application, collection of clinical data, clinical trials of the CSS the timing related to the revocation of the CTO and the impacts of resumption of trading on liquidity. Such statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements and are not guarantees of future performance of CVR Medical. No assurance can be given that any of the events anticipated by the forward-looking statements will occur or, if they do occur, what benefits CVR Medical will obtain from them. These forward-looking statements reflect management’s current views and are based on certain expectations, estimates and assumptions which may prove to be incorrect. A number of risks and uncertainties could cause our actual results to differ materially from those expressed or implied by the forward-looking statements, including: (1) a downturn in general economic conditions in North America and internationally, (2) the inherent uncertainties and speculative nature associated with commercialization of technology and the practice of medicine, (3) a change in health regulations, (4) any number of events or causes which may delay or cease commercialization and development of the CSS, (5) the risk that CVR Medical does not execute its business plan, (6) the inability to retain key employees, (7) inability to finance operations and growth, (8) the timing expectations for the new De Novo submission and collection of additional clinical data; and (9) other factors beyond CVR Medical’s control. These forward-looking statements are made as of the date of this news release and, except as required by law, CVR Medical assumes no obligation to update these forward-looking statements, or to update the reasons why actual results differed from those projected in the forward-looking statements.
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