SAN DIEGO, April 3 /PRNewswire-FirstCall/ -- CryoCor, Inc. reported today that its Annual Report on Form 10-K included an audit opinion with a "going concern" qualification. A going-concern qualification is a statement from the company's independent registered public accounting firm expressing substantial doubt, based upon current financial resources, whether the company can continue to meet obligations over the next year. In its annual report, CryoCor indicated that it had sufficient working capital to fund its operations until December 2007 and to pay off its existing debt, and that additional capital would be needed to fund operations into 2008. CryoCor has previously announced that it is pursuing several financing options, including a small equity financing, a restructuring of its existing debt, and a corporate partnership.
CryoCor is a medical device company focused on the treatment of cardiac arrhythmias, and has filed an application for pre-market approval, or PMA, for the treatment of atrial flutter with the United States Food and Drug Administration, or FDA. CryoCor has previously announced that it expects to receive a decision from the FDA on this PMA by August 2007. Additionally, CryoCor expects to complete the enrollment in its pivotal trial for the treatment of atrial fibrillation in the second quarter of 2007.
About CryoCor
CryoCor is a medical technology company that has developed and manufactures a disposable catheter system based on its proprietary cryoablation technology for the minimally invasive treatment of cardiac arrhythmias. CryoCor's product, the CryoCor Cardiac Cryoablation System, or the Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The Cryoablation System has been approved in Europe for the treatment of atrial fibrillation, or AF, and atrial flutter, or AFL, the two most common and difficult to treat arrhythmias, since 2002. For more information please visit CryoCor's website at http://www.cryocor.com/ .
Forward Looking Statements
The statements in this press release that are not descriptions of historical facts are forward-looking statements that are subject to risks and uncertainties. These include statements included in this press release related to the period over which CryoCor's existing working capital will enable it to fund its operations and pay off its existing debt, CryoCor's ability to obtain financing, restructure its existing debt, or enter into a corporate partnership, the expected time when CryoCor expects to receive a decision from the FDA on its PMA for the treatment of AFL, the possibility of CryoCor's receiving FDA approval for the use of the Cryoablation System to treat AF and AFL, and the expected time when CryoCor expects to complete enrollment in its pivotal trial for AF, all of which are prospective. Such statements are only predictions and reflect CryoCor's expectations and assumptions as of the date of this press release based on currently available operating, financial, and competitive information. The actual events or results may differ materially from those projected in such forward-looking statements due to a number of factors, including risks involved with CryoCor's ability to fund its operations until December 2007 and pay off its existing debt, and to obtain additional capital to continue to fund its operations into 2008; risks involved with CryoCor's ability to obtain regulatory approval in the United States for the Cryoablation System for use in treating AFL and AF within its anticipated timeframes, if at all; risks associated with CryoCor's ability to successfully commercialize the Cryoablation System in the United States and elsewhere if the Cryoablation System is approved for use in the United States; risks associated with CryoCor's dependence on patents and proprietary rights; risks associated with CryoCor's protection and enforcement of its patents and proprietary rights; risks associated with the development or availability of competitive products or technologies; and the other risks and uncertainties identified in CryoCor's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. CryoCor expressly disclaims any intent or obligation to update any of these forward-looking statements.
Contact:
CryoCor, Inc.
Gregory J. Tibbitts
Chief Financial Officer
(858) 909-2200
