SAN DIEGO, July 27 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, announced today that based upon its meeting with officials of the U.S. Food and Drug Administration, or FDA, held on July 26, 2006, that the Company intends to proceed with filing an amendment to its pre-market approval application for the treatment of atrial flutter, or AFL. CryoCor expects the amendment to be filed in the third quarter of 2006.
CryoCor previously reported that the Company received a letter from the FDA that the Company's Cardiac Cryoablation System was not approvable for the treatment of AFL at present. The FDA stated that the data presented did not meet the FDA's chronic efficacy criteria. Since receiving the letter from the FDA, CryoCor has retained expert physicians in the field of electrophysiology to review the clinical data for all patients treated in its pivotal trial to independently determine the success of each procedure. Additionally, CryoCor engaged external regulatory consultants to assist with its efforts to reevaluate the clinical data and advise CryoCor on a potential amendment to its PMA based on additional information. CryoCor presented the reevaluation of the AFL clinical data to the FDA for purposes of determining chronic efficacy. There can be no assurance that the FDA will determine that the data presented in the amendment meet the FDA's chronic efficacy criteria or that the amended PMA will be approved by the FDA.
Ed Brennan, President and CEO of CryoCor said, "We are very pleased that our meeting with FDA went well and we felt that the Agency was receptive to our plans to amend the PMA. We discussed both the content and structure of the amendment, and look forward to submitting the amendment to the PMA in the near term."
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 Company's ability to reduce its cash burn as much as it anticipates within the timeframes it anticipates and otherwise meet its financial guidance, access additional financing when and to the extent necessary and 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.
CryoCor, Inc. The Ruth Group
Gregory J. Tibbitts Stephanie Carrington / Nick Laudico (investors)
Chief Financial Officer (646) 536-7017 / 7030
(858) 909-2200 email@example.com@firstname.lastname@example.org
Jason Rando (media)
CONTACT: Gregory J. Tibbitts, Chief Financial Officer of CryoCor, Inc.,858-909-2200, email@example.com; or investors, Stephanie Carrington,646- 536-7017, firstname.lastname@example.org, or Nick Laudico, 646-536-7030,email@example.com, or media, Jason Rando, 646-536-7025,firstname.lastname@example.org, all of The Ruth Group for CryoCor, Inc.