CVR Medical (TSXV: CVM) Entering Into Pre-Pivotal Trial Phase A Step Closer To FDA Clearance
Vancouver, British Columbia - February 1, 2018 (Newsfile Corp.) (Investorideas.com Newswire) CVR Medical Corp. (TSXV: CVM) (FSE: B3BN) (OTCQB: CRRVF) ("CVR Medical") announces the launch of their Pre-Pivotal Trial clinical substantiation phase for the "Carotid Stenotic Scan (CSS)" device. This critical stage, prior to launch of final phase Pivotal Trials, will be conducted at Thomas Jefferson University Hospital (Philadelphia, PA), Henry Ford Hospital (Detroit, MI), and several other top-tier clinical research institutions within the United States. Transition from Pre-Pivotal trial phase to Pivotal Trials is expected to occur in the early part of February 2018, and only requires the placement of wireless CSS devices across CVR's full clinical trial footprint. With the data produced through the Pivotal Trials, CVR will validate the safety and accuracy of their patented device as required for submission to FDA for market clearance.
"Now that we have cleared the major manufacturing and logistical hurdles which all companies encounter when attempting to manufacture a state of the art medical device and arm clinicians across the globe, it is time to start bringing the pre-market phase of this project to a close." CVR COO Tony Robinson declares with assurance. "The product is designed, the market has told us there is a need, and we have laid the path to manufacture the CSS, now it is time to execute. We intend for this last clinical phase to be swift and efficient, a closing to this chapter of development."
CVR Medical plans to announce the additional Pivotal Trial locations immediately upon IRB approval.
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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