SAN DIEGO, Oct. 16 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today a delay for filing an amendment to its pre-market approval, or PMA, application for the treatment of atrial flutter, or AFL. CryoCor expects the amendment to be filed with the U.S. Food and Drug Administration, or FDA, by the end of November of 2006.
Ed Brennan, President and CEO of CryoCor said, “This is an important filing for CryoCor and we have thoroughly reviewed the safety and effectiveness data from our AFL pivotal study. We believe the additional time will allow us to provide supplementary information to these data. We will be presenting our strongest case and look forward to working with the FDA in seeking approval for the treatment of AFL with our system.”
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. The Company’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 AF and AFL, 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 Cryoablation System for the treatment of AF. 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 included in this press release related to CryoCor’s proposed amendment to its PMA for AFL including CryoCor’s timing and the possibility of receiving approval for the treatment for AFL, 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 CryoCor’s ability to obtain regulatory approval in the United States for its Cardiac Cryoablation System for use in treating AFL and AF within its anticipated timeframes, if at all; risks associated with the Company’s ability to amend its PMA for AFL and ultimately receive approval from the FDA for the use of its Cryoablation System to treat AFL; 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: CryoCor, Inc. The Ruth Group Gregory J. Tibbitts Stephanie Carrington / Nick Laudico (investors) Chief Financial Officer (646) 536-7017 / 7030 (858) 909-2200 scarrington@theruthgroup.comgtibbitts@cryocor.comnlaudico@theruthgroup.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com
CryoCor, Inc.
CONTACT: Gregory J. Tibbitts, Chief Financial Officer of CryoCor, Inc.,+1-858-909-2200, gtibbitts@cryocor.com; or Investors: Stephanie Carrington,+1-646-536-7017, scarrington@theruthgroup.com, or Nick Laudico,+1-646-536-7030, nlaudico@theruthgroup.com, or Media: Jason Rando,+1-646-536-7025, jrando@theruthgroup.com, all of The Ruth Group, forCryoCor
Web site: http://www.cryocor.com/
