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Vancouver, British Columbia--(Newsfile Corp. - January 25, 2021) - CVR Medical Corp. (TSXV: CVM) (OTC: CRRVF) ("CVR Medical" or the "Company" or "we") a Canadian listed and US based healthcare company in the medical device market is pleased to share a message from new Chief Executive Officer (CEO) Michael Rhodes:
I am delighted to be offered the opportunity to lead CVR Medical Corp. as we focus on getting our Carotid Stenotic Scan (CSS) into the hands of primary care doctors so that patients at risk of ischemic stroke can be diagnosed earlier, helping to save lives and improve quality of life. The Board of Directors have worked diligently to restructure the business and my primary focus from day one is to create the team and drive the actions needed for a new De Novo submission at the earliest opportunity.
I've had the advantage of working closely with the CSS engineering team and the regulatory consultants as a consultant to CVR Global during the original FDA application process and this has provided me with first-hand knowledge of the CSS device and its regulatory status. The FDA provided excellent feedback after the original De Novo submission and, to ensure ongoing alignment with the FDA and eliminate any potential ambiguity, I intend to use the FDA Q-Submission program to ensure that our response and plans to action their feedback is designed to meet FDA expectations from the outset. The project scope and timeline will quickly follow.
It has been a little over 2-years since the original CSS De Novo submission and there is still no medical device on the market readily available to help primary care doctors evaluate at risk patients for carotid arterial stenosis. With stroke accounting for approximately 1 of every 19 deaths in the United States and total direct medical stroke-related costs projected to more than double to $94.3 billion by 2035, I believe that the CSS is uniquely positioned to solve the technical challenge and fulfill the urgent need to diagnose patients earlier.
During the same period, we have seen new technologies gain a foothold and influence user expectations in the ultrasound arena. Unlike the CSS, these ultrasound products are not available for asymptomatic, at risk patients, but they have created greater interest in sonography which is to our advantage. They have also changed the form factor with increasing use of highly portable smartphone-based products, and we will thoroughly explore the market opportunity for smartphone or similar derivatives of the CSS for next generation products along with additional revenue streams such as software subscription. Achieving FDA clearance for the existing fully integrated cart-based CSS will pave the way for 510(k) submissions for future derivatives.
About CVR Medical
CVR Medical Corp. is a healthcare company that operates in the medical device industry focused on the commercialization of its disruptive, proprietary Carotid Stenotic Scan device ("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 Medical's shares are listed on the OTC under the symbol "CRRVF". The Company is listed for trading under the symbol "CVM". 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
(signed) Michael Rhodes
Chief Executive Officer
For further information contact:
Paul Blunden, M.D., President/Director and interim CFO
This press release contains forward-looking information that involves various risks and uncertainties regarding future events related to: trading on and dialogue with the Exchange, communications and negotiations with CVR Global, dialogue with certain advisors, the Proposed Restructuring, the License Agreement, the Review, certain corporate and securities law requirements, raising capital and potential litigation. 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 the Company. 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 the Company 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 failure or material setback in the Company satisfying the remaining conditions outlined by the TSX-V; (2) a failure of the Company to raise sufficient capital to relaunch the Company; (3) an inability to complete the Proposed Restructuring with CVR Global: (4)a downturn in general economic conditions in North America and internationally; (5)the inherent uncertainties and speculative nature associated with commercialization of technology and the practice of medicine; (6) a change in health regulations; (7) any number of events or causes which may delay or cease commercialization and development of the CSS Device; (8) the risk that the Company does not execute its business plan; (9) the risk of litigation between the Company and certain shareholders and the risk of litigation generally; (10) an inability to retain key employees; (11) an inability to finance operations and growth; (12) compliance with certain corporate and securities law requirements; and (13) other factors that are beyond the Company's control. These forward-looking statements are made as of the date of this news release and, except as required by law, the Company 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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