DENVER, NC / December 27th, 2018 / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB:CRRVF) (“CVR Medical”) a Canadian listed and US based healthcare company in the medical device sector announces in follow-up to the previously released press release on December 12th, that its patented Carotid Stenotic Scan (CSS) has passed the IEC 60601-1, General Requirements for Basic Safety and Essential Performance – Electrical Safety testing conducted by TUV Rheinland of North America. This, combined with the previously announced EMC testing, concludes all required medical electrical equipment testing mandated for submission by the US FDA. TUV Rheinland of North America, is one of the leading providers of product safety certifications worldwide, covering an assortment of items such as medical devices, home
appliances, audio/video products, medical products, textiles and telecommunication equipment. The International Electrotechnical Commission (IEC), based in Geneva, Switzerland, publishesthe 60601 series of technical standards that allow medical device developers to demonstrate the safety and essential performance of their medical equipment. Upon completion of EMC testing, TUV North America started IEC 60601-1 safety testing which includes, software and hardware validation , fire and electrical safety and mechanical failure. With the receipt of the EMC and Electrical Safety Reports provided by TUV upon completion of the testing, CVR is now finalizing
all documentation for the near immediate FDA submission. As announced, CVR’s previous guidance relating to FDA submission remains unchanged for Q1 2019.
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 (CSS). The CSS device 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 in pivotal clinical trials in preparation for its planned submission to the FDA. CVR is led by an experienced and proven team of professionals with extensive healthcare, medical device, international expansion, regulatory and sales experience. CVR Medical trades on the TSX Venture Exchange 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
ON BEHALF OF THE BOARD:
(signed) “Peter Bakema”
CEO, President & Director
For further information contact:
Peter Bakema, CEO, President and Director
Marc S. Lubow.
Executive Vice President
This press release contains forward-looking information that involves various risks and uncertainties regarding future events related to the Joint Venture. 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 forwardlooking 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 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 Joint Venture, (5) the risk that the Company or the Joint Venture does not execute its business plan, (6) inability to retain key employees, (7) inability to finance operations and growth, and (8) other factors 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.
THE TSX VENTURE EXCHANGE INC. HAS NEITHER APPROVED NOR DISAPPROVED THE CONTENTS OF THIS PRESS RELEASE. NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.