FREMONT, CA--(MARKET WIRE)--Jul 19, 2006 -- Cardima, Inc. (OTC BB:CRDM.OB - News) today announced that the U.S. Food and Drug Administration (FDA) has granted a review of the scientific dispute underlying the FDA’s refusal to approve the Company’s 2002 pre-market approval application (PMA) for the REVELATION® Tx Micro-catheter System. The review will be conducted by the FDA’s Medical Devices Dispute Resolution Panel and is expected to take place in either the fourth quarter of this fiscal year or the first quarter of fiscal year 2007. After hearing presentations from both the FDA and Cardima and conducting its own review of the issues, the Panel will make a recommendation to the Director of the FDA’s Center for Devices and Radiological Health as to whether it believes the PMA should be approved. The Director will then make his own decision on whether to approve the PMA.
“We are pleased that the FDA has referred our PMA for the REVELATION® Tx to this Panel,” said Cardima Chief Executive Officer, Gabriel B. Vegh. “We believe that the Panel’s independent experts, who have had no previous role in reviewing this PMA, will give it a fresh look, although we cannot offer any assurance that they will find our data compelling.”
About Cardima, Inc.
Since our incorporation in November 1992, we have developed, produced and sold a variety of micro-catheters designed for the diagnosis and treatment of the two most common forms of cardiac arrhythmias: atrial fibrillation (AF) and ventricular tachycardia (VT). Since 2001 our efforts have primarily focused on developing differentiated products that diagnose and treat AF, including our REVELATION® Tx micro-catheter for use in the Electrophysiology (EP) market, and our Surgical Ablation System (SAS) for use in the surgical market.
Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by such forward-looking statements. Potential risks and uncertainties include: the uncertainties associated with the prospects for FDA approval of our pre-market approval application for the REVELATION® Tx; the prospect for any future clinical trials or regulatory activities; the risks associated with the Apix loan facility’s restrictive covenants, security interest, fee provisions and other terms and conditions; the risk that the Company will not be able to raise additional capital in the immediate term as needed to continue operations and the risk that we will be unable to secure a strategic transaction involving the Surgical Ablation System. Additional risks and uncertainties are set forth in the Company’s Annual Report on Form 10-K for the year ended December 31, 2005, the Company’s Quarterly Report on Form 10-QSB for the first quarter ended March 31, 2006, and in the Company’s subsequent SEC filings. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof, or to reflect the occurrence of unanticipated events or changes in the Company’s plans or expectations.
Contact: Contact: Cardima, Inc. Gabriel B. Vegh 510-354-0300 http://www.cardima.com
Source: Cardima, Inc.
