DENVER, NC / November 5th, 2019, / CVR Medical Corp. (CVM.V) (TSXV: CVM) (OTCQB: CRRVF) (“CVR Medical” or the “Company”) a Canadian listed and US based healthcare company in the medical device sector is pleased to announce that, as of November 1, 2019, the British Columbia Securities Commission (the “BCSC”) has granted a full revocation (the “Revocation”) of the cease trade order issued by the BCSC against the Company (the “Cease Trade Order”).
The Cease Trade Order was originally imposed as a result of the Company’s failure to file certain annual audited financial statements, management discussion and analysis and the certification of the annual audited financial statements, pursuant to National Instrument 51-102. Since then, the Company has filed the annual audited financial statements for the year ended December 31, 2018, related management discussion and analysis and the certification of annual filings for the year ended December 31, 2018. The Company has completed the filing of all continuous disclosure documents and all of the Company’s continuous disclosure documents can be reviewed on SEDAR.
CVR Medical announces that Tony Robinson has resigned as Chief Operations Officer of the Company due to family reasons, effective October 27, 2019. Qualified candidates are currently being vetted and the Company will fill the management position as soon as possible.
The De Novo Submission to the US Food and Drug Administration (the “FDA”)
In January 2019, the Company prepared and sent in the a De Novo submission (the “Submission“) for the Carotid Stenotic Scan device (the “CSS“) to the FDA. Feedback was received from the FDA within the allotted time regarding perceived deficiencies and recommendations for enhancement of the Submission. Immediately upon receipt of this communication an in-person meeting was requested with the FDA for clarification, which was conducted on May 31, 2019 (the “Meeting“). The Meeting was attended by the expert review team assigned to the Submission by the FDA, as well as representatives from CVR Medical’s leadership, clinical advisory board members, and regulatory consultants from both Hyman, Phelps, & McNamara, P.C. & J.D. Lymon.
The Meeting provided the Company with feedback and clarification on several topics:
- the proposed Indications for Use;
- the amended clinical implementation plan (including statistical justification) (the “CIP“); and
- the outline of the overall Submission trajectory.
The Company came out of the Meeting feeling very confident in the understanding of the FDA recommendations, with a clearly defined pathway to approval, and the Company’s ability to work with the FDA in amending the required documentation, conducting additional testing, and updated the CIP. The main hurdle that resulted from the Meeting was that the Company would be required to add an additional (~244) patients under the updated CIP to acquire the statistical justification requested by the FDA.
Given capital constraints and management inefficiencies, the Company was unable to collect the required data in the time frame dictated by the FDA. As a result, the Company announced on September 26, 2019 that it withdrew the January 2019 De Novo submission for the CSS from the FDA. The Company continues to collect clinical data and will ramp up collection as capital allows, with the intention of submitting a new De Novo submission to the FDA in the first quarter of 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 Carotid Stenotic Scan (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. On many developmental, regulatory, and manufacturing aspects related to the CSS, CVR Medical works in unison with CVR Global Inc. and the abbreviation “CVR” is used in describing the collaboration. 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” and on the OTCQX under the symbol “CRRVF”. Additional information regarding CVR Medical 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. 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) inability to retain key employees, (7) inability to finance operations and growth, and (8) 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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