SAN DIEGO, June 19 /PRNewswire-FirstCall/ -- CryoCor, Inc. , a medical device company focused on the treatment of cardiac arrhythmias, today provided an update on its clinical progress.
The Company reiterated that it is scheduled to present on June 27, 2007 clinical data related to its pre market approval, or PMA, application for the treatment of atrial flutter, or AFL, at an Advisory Panel meeting. The United States Food and Drug Administration, or FDA, will convene the Advisory Panel meeting to advise the FDA on whether or not the chronic effectiveness data in CryoCor’s pivotal trial for the treatment of AFL provides a reasonable assurance of effectiveness. The Company’s communications with the FDA have been routine, and the Company indicated that it is not aware of any other developments or information related to the upcoming panel meeting.
Enrollment in CryoCor’s atrial fibrillation, or AF, pivotal trial has continued at the expected pace. The Company expects to complete enrollment shortly and needs to enroll only three and eight additional patients to complete enrollment.
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 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 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 cryoablation system for the treatment of atrial fibrillation. In addition, the Company conducted a pivotal trial for the treatment of atrial flutter and filed an application for pre-market approval, or PMA, with the United States Food and Drug Administration, or FDA, in 2005. The FDA did not approve the initial PMA filing for the treatment of atrial flutter and CryoCor amended its PMA based upon a different analysis of chronic effectiveness. CryoCor will present this analysis of chronic effectiveness at an FDA Advisory Panel meeting on June 27, 2007. 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 related to the FDA Advisory Panel hearing to review CryoCor’s PMA for atrial flutter, whether the Advisory Panel will recommend that the FDA approve CryoCor’s PMA for the treatment of AFL, whether the FDA will approve CryoCor’s cryoablation system for the treatment of AFL, whether the Advisory Panel and/or the FDA will consider the chronic effectiveness data submitted by CryoCor in connection with its amended PMA for AFL to be sufficient to merit approval of the Company’s cryoablation system for the treatment of AFL, and the timing of when CryoCor will complete enrollment in its AF pivotal trial, 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 obtain regulatory approval in the United States for its 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 complete enrollment in its atrial fibrillation pivotal trial and submit a PMA for atrial fibrillation; risks associated with the Company’s ability to receive approval from the FDA for the use of its cryoablation system to treat atrial flutter; risks associated with the Company’s ability to successfully commercialize its cryoablation system in the United States and elsewhere if its 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 The Ruth Group Gregory J. Tibbitts Zack Kubow (investors) Chief Financial Officer (646) 536- 7020 (858) 909-2200 zkubow@theruthgroup.comgtibbitts@cryocor.com Jason Rando (media) (646) 536-7025 jrando@theruthgroup.com
CryoCor, Inc.
CONTACT: Gregory J. Tibbitts, Chief Financial Officer for CryoCor, +1-858-909-2200, gtibbitts@cryocor.com; or Zack Kubow (investors), +1-646-536-7020, zkubow@theruthgroup.com, or Jason Rando (media), +1-646-536-7025,jrando@theruthgroup.com, both for The Ruth Group
Web site: http://www.cryocor.com/
