CryoCor, Inc. Receives Communication From FDA
SAN DIEGO, Feb. 2 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) informing the Company that its PMA for the treatment of atrial flutter using the Cardiac Cryoablation System is not approvable at present. In the letter the FDA stated that their interpretation of the data presented by the Company demonstrated that the product's success rate for the treatment of atrial flutter did not meet their chronic efficacy criteria.
Greg Ayers, CryoCor's Chief Executive Officer, said, "We continue to believe that the data generated by our pivotal trial support the safety and efficacy of the product for the treatment of atrial flutter. We are reviewing and evaluating the PMA data, and expect to continue our constructive discussions with the FDA to determine the appropriate path going forward. Our pivotal trial to evaluate the safety and efficacy of our Cardiac Cryoablation System for the treatment for atrial fibrillation is in no way impacted by this FDA communication. To date, we have enrolled 103 patients in this trial with over 20 centers involved, and remain confident of our estimated timelines."
CryoCor will also hold a Web cast and conference call today at 5:00 p.m. EST / 2:00 p.m. PST to discuss this information. The dial-in numbers are 1-877-407-0784 for domestic callers, and 1-201-689-8560 for international callers. A live Web cast of the conference call will be available online from the investor relations page of the Company's corporate Web site at http://www.cryocor.com.
After the live Web cast, the call will remain available on CryoCor's Web site for at least 30 days following presentation. In addition, a telephonic replay of the call will be available. The replay dial-in numbers are 1-877-660-6853 for domestic callers 1-201-612-7415 for international callers. Please use account number 3055 and conference ID number 191779.
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 data presented by CryoCor to the FDA in its PMA for the treatment of atrial flutter using the CryoCor Cardiac Cryoablation System, the safety and effectiveness of the CryoCor Cardiac Cryoablation System, the Company's continuing discussions with the FDA regarding the PMA data, and the 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; 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 The Ruth Group Gregory J. Tibbitts Stephanie Carrington / Nick Laudico Chief Financial Officer (investors) (858) 909-2200 (646) 536-7017 / 7030 firstname.lastname@example.org@email@example.com Jason Rando (media) (646) 536-7025 firstname.lastname@example.orgCryoCor, Inc.
CONTACT: Gregory J. Tibbitts, Chief Financial Officer of CryoCor, Inc.,+1-858-909-2200, email@example.com; or Investors: Stephanie Carrington,+1-646-536-7017, firstname.lastname@example.org, or Nick Laudico,+1-646-536-7030, email@example.com, or Media: Jason Rando,+1-646-536-7025, firstname.lastname@example.org, both of The Ruth Group, forCryoCor, Inc.
Web site: http://www.cryocor.com//