FDA Dispute Resolution Panel Recommends to Not Approve REVELATION® Tx Microcatheter System
FREMONT, Calif. (April 20, 2007) - Cardima, Inc. (OTCBB: CADM.OB), a medical device company focused on the treatment of atrial fibrillation, announced today that the FDA’s Medical Device Dispute Resolution Panel, which met on April 19, 2007, recommended to not approve the Company’s REVELATION® Tx Microcatheter System. Even though the Panel commented favorably on the need for this type of device, the Panel felt that efficacy data was not sufficiently clear and supportive for approval. The REVELATION® Tx system is a minimally invasive, single-use, microcatheter-based product designed to provide easy access to arrhythmia-causing tissue, creating linear lesions or restricted pathways, and restoring normal sinus rhythm to the heart using radiofrequency (RF) energy. Gabe Vegh, Chief Executive Officer of Cardima said, " I am disappointed that the Panel voted against the approval of the REVELATION® Tx. Cardima will consider its options regarding this decision in the US. The Company will continue to market its next generation ablation EP systems, which include the REVELATION® T-Flex and the INTELLITEMP®, in the European Union and the rest of the world where it is licensed to promote and sell these products. Also Cardima will continue to search for marketing partners for its US-approved Surgical Ablation System (SAS) and in the markets outside of the US where it is licensed to promote and sell the product. In addition, the Company will continue to promote its Diagnostic System which is approved in the US and the rest of the world.”About Cardima
Cardima, Inc. has developed the PATHFINDER® and REVELATION® Series of diagnostic catheters, the INTELLITEMP® Energy Management Device, and the Surgical Ablation System (SAS). All of these devices are CE marked and received U.S. FDA 510(k) clearance. The REVELATION® Series of ablation catheters with the INTELLITEMP® EP Energy Management Device was developed and marketed for the treatment of atrial fibrillation (AF) after receiving CE mark approval in Europe; it is not currently available in the U.S.
Forward-Looking Statements
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 any new devices; the prospect for any future clinical trials or regulatory activities; 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-KSB for the year ended December 31, 2006, the Company's Quarterly Report on Form 10-QSB for the third quarter ended September 30, 2007, 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.