SAN DIEGO, Jan. 10 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today an update to the status of its atrial flutter PMA application with the U.S. Food and Drug Administration (FDA).
The FDA has recently notified the Company that it continues to actively review the Company's PMA following the submission of additional data in October 2005. This second review cycle began with the submission of the additional information and could take as long as 180 days from that date to complete. The first review cycle commenced July 14, 2005, when the Company submitted the final module of its PMA that contained the clinical safety and efficacy data from the U.S. clinical trial and concluded with the FDA request for the additional data. The Company's current expectation is that it remains on its original timeline in seeking approval from the FDA to market its Cardiac Cryoablation System in the U.S. for the indication of atrial flutter.
Gregory Ayers, Chief Executive Officer, stated, "Our current timeline for anticipated PMA approval of our system's use to treat atrial flutter is consistent with our original forecast of two review cycles of 180 days each. As previously communicated, the information requested by the FDA in October 2005, and our subsequent discussions with the FDA since October 2005, have been related to additional statistical analysis of the patient data, queries on clinical interpretations and data related to specific patients. We consider these discussions normal and routine. We are pleased to hear that the FDA continues to work on our PMA filing in this second review cycle."
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. The Company's product, the CryoCor Cardiac Cryoablation System, is designed to treat cardiac arrhythmias through the use of cryoenergy, or extreme cold, to destroy targeted cardiac tissue. The CryoCor System has been approved in Europe for the treatment of atrial fibrillation and atrial flutter, the two most common and difficult to treat arrhythmias, since 2002. In the United States, CryoCor is conducting a pivotal trial to evaluate the safety and efficacy of the CryoCor Cardiac Cryoablation System for the treatment of atrial fibrillation, and has submitted a PMA for the treatment of atrial flutter. For more information please visit the Company'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 related to the timing and potential receipt of regulatory approval for the CryoCor Cardiac Cryoablation System in the United States for use in treating atrial flutter and atrial fibrillation, all of which are prospective. Such statements are only predictions and reflect the Company'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 the Company's ability to obtain regulatory approval in the United States for its Cardiac Cryoablation System for use in treating atrial flutter and atrial fibrillation within its anticipated timeframes, if at all; risks associated with the Company's ability to add additional clinical sites for and complete enrollment in its atrial fibrillation pivotal trial and submit a PMA for atrial fibrillation; risks associated with the Company's ability to successfully commercialize its Cardiac Cryoablation System in the United States and elsewhere if its Cardiac Cryoablation System is approved for use in the United States; risks associated with the Company's dependence on patents and proprietary rights; risks associated with the Company'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 the Company's filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. The Company expressly disclaims any intent or obligation to update any of these forward-looking statements.
CONTACT: Gregory J. Tibbitts, Chief Financial Officer of CryoCor, Inc.,+1-858-909-2200, firstname.lastname@example.org; or Investors, Stephanie Carrington,+1-646-536-7017, email@example.com, or Nick Laudico,+1-646-536-7030, firstname.lastname@example.org, or Media, Jason Rando,+1-646-536-7025, email@example.com, all of The Ruth Group, forCryoCor, Inc.