Vancouver, British Columbia--(Newsfile Corp. - February 20, 2018) - CVR Medical Corp. (TSXV: CVM) (FSE: B3BN) (OTCQB: CRRVF) ("CVR Medical") announces the launch of pivotal clinical trials beginning Monday March 5, 2018 for the Carotid Stenotic Scan (CSS) device. This anticipated milestone represents the final phase of clinical substantiation which CVR will use to support the upcoming FDA submission. Initially, Thomas Jefferson University Hospital (Philadelphia, PA) and Henry Ford Hospital (Detroit, MI) will act as the key pivotal trials locations, but CVR plans to expand the footprint as other locations come online, increasing the speed of data procurement and shortening the timeframe to submission.
"The project is gaining momentum," comments CVR COO/EVP Tony Robinson, "and this step is definitely one of the more critical milestones we have been working toward. Whether the clinical trials, the manufacturing agreement with Canon, or the nearing FDA submission with the support of Duval & Associates; they all bring us one step closer to realizing our goal of improving healthcare."
The clinical substantiation will be supported with five devices across the Thomas Jefferson footprint, three devices within the Henry Ford Healthcare System, and multiple devices within trials at pending clinical sites. The spectrum of locations will support a diverse and rapid acquisition process.
For additional information on the organization, leadership, and current news please visit the company website www.CVRMed.com.
About CVR Medical
CVR Medical is a company that is involved in an equal parts joint venture with CVR Global Inc. (the "Joint Venture"). The Joint Venture operates in the medical industry focused on the commercialization of a proprietary subsonic, infrasonic, and low frequency sound wave analysis technology and has patents to a diagnostic device designed to detect and measure carotid arterial stenosis. CVR Medical is managed by a proven technical team. CVR Medical trades on the TSX Venture Exchange under the symbol CVM.
ON BEHALF OF THE BOARD:
(signed) "Peter Bakema"
CEO, President & Director
For further information contact:
Peter Bakema, CEO, President and Director
Telephone: (734) 718-5115
Brisco Capital Partners Corp.
Scott Koyich, President
Telephone: (403) 262-9888
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 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 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.
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