CVR Medical has CTO removed, COO Robinson resigns
2019-11-05 11:06 ET - News Release
Mr. Peter Bakema reports
CVR ANNOUNCES REVOCATION OF CEASE TRADE ORDER AND RESIGNATION OF CHIEF OPERATIONS OFFICER
As of Nov. 1, 2019, the British Columbia Securities Commission has granted a full revocation of the cease trade order issued by the BCSC against CVR Medical Corp.
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:
1. the proposed Indications for Use;
2. the amended clinical implementation plan (including statistical justification) (the "CIP"); and
3. 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".
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