Cardima Receives FDA Acceptance and Closure of PMA Third Module.

Business Editors & Health/Medical Writers

FREMONT, Calif.--(BW HealthWire)--June 10, 2002

Cardima(R), Inc. (Nasdaq:CRDM), developer of the REVELATION(TM) Tx and REVELATION(TM) Helix(TM) microcatheter systems, today announced receipt of the U.S. Food and Drug Administration's (FDA) acceptance and closure of the third module of the REVELATION Tx pre-market approval (PMA). This is the third of five modules necessary to complete the PMA application process in order to obtain FDA approval of the REVELATION Tx for the treatment of atrial fibrillation (AF).

During 2001, Cardima submitted four of the five required modules for its PMA application. In October 2001, the Company announced that the FDA had accepted and closed two of the modules. Review of the fourth remaining pre-clinical module is progressing, and Cardima is working closely with the FDA to complete the review process. The fifth and final PMA module will include six-month follow-up data on patients treated with the REVELATION Tx system in the Phase III study, which is expected to be completed in June 2002. The Company believes that it had enrolled a sufficient number of patients to complete the Phase III study at the beginning of 2002.

"Receiving acceptance of the third module represents another benchmark in our objective to bring the REVELATION Tx microcatheter system to market in the U.S.," said Gabriel Vegh, President and Chief Executive Officer of Cardima. "We are now in the sixth and final month of patient follow-up and we plan to submit the fifth PMA module in the third quarter of this year. We are very focused on completing our Phase III clinical trial in the U.S. for the REVELATION Tx and increasing sales of the REVELATION series of microcatheters, which potentially treat all forms of AF, in both European and U.S. markets."

Cardima, Inc. developed the linear ablation REVELATION Tx and REVELATION Helix systems for treating AF. Since AF afflicts an estimated 2 million people in the United States and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a minimally invasive, single-use system with the potential of curing AF, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies in the approval process. Phase I and II data with the REVELATION Tx microcatheter system have demonstrated safety and promising efficacy. The Company is targeting FDA approval for the REVELATION Tx by the end of calendar year 2002. The Company's REVELATION Helix received CE mark approval in December 2001 with initial market launch in the European Union in the first quarter of 2002.

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 in such forward-looking statements. Potential risks and uncertainties include the Company's ability to raise additional capital, conduct successful clinical trials, obtain regulatory approvals and gain acceptance from the marketplace for its products. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2001, Quarterly Reports on Form 10-Q and other reports filed with the Securities and Exchange Commission. 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.