Cardima Submits PMA Application to FDA for Approval of REVELATION Tx for Treatment of Atrial Fibrillation.

Business Editors & Health/Medical Writers

FREMONT, Calif.--(BUSINESS WIRE)--Sept. 20, 2002

Cardima(R), Inc. (Nasdaq:CRDM) -- developer of the REVELATION(R) Tx and REVELATION(R) Helix microcatheter systems for treating atrial fibrillation (AF) -- today announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) for approval to market the REVELATION(R) Tx linear ablation catheter to treat paroxysmal AF in the U.S. This PMA application is the final in the module PMA process, presenting the results of the clinical study.

"We believe the REVELATION Tx's patented technology could represent a new standard of care for treating this disease," commented Gabriel Vegh, Chief Executive Officer of Cardima. "If approved, electrophysiologists would have the first FDA-approved minimally invasive linear ablation device for treating AF patients, potentially improving their quality of life by reducing the number and severity of AF episodes.

"The PMA submission for the REVELATION Tx is the culmination of five years of technical, pre-clinical and clinical work, and we are extremely pleased to reach this major milestone," continued Mr. Vegh.

Cardima also announced that it intends to ask the FDA for an expedited review of the REVELATION Tx PMA application. Currently, there are no other FDA-approved devices to treat this disease. The Company is targeting FDA approval for the REVELATION Tx in the first quarter of 2003.

About Atrial Fibrillation

AF is a serious cardiac arrhythmia that affects an estimated 2 million Americans, with 160,000 new cases diagnosed in the U.S. each year. Approximately one-half of AF cases are considered treatable, and because the incidence of AF increases with age, demographic trends bode well for the market potential of a new therapy. AF is characterized by the irregular and very uncomfortable beating of the heart's atrial chambers and results when the normal electrical conduction system of the atria malfunctions, leading to irregular and chaotic electrical signals. During AF, the regular pumping action of the atria is replaced by irregular, disorganized and quivering spasms of atrial tissue, which results in the failure of the atria to fill the ventricles completely and, consequently, the failure of the heart to pump adequate amounts of blood throughout the body. These spasms may lead to reduced blood flow, blood clot formation, stroke and even death. Symptoms of AF typically include a rapid and irregular heartbeat, palpitations, discomfort and dizziness.

About Cardima

Cardima, Inc. developed the linear ablation REVELATION(R) Tx system for treating AF. Since atrial fibrillation afflicts an estimated 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(R) Tx linear ablation 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(R) Tx microcatheter system have demonstrated safety and promising efficacy. The Company's REVELATION(R) 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 whether the Company's premarket approval application will be approved by the U.S. FDA, 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 filed with the Securities and Exchange Commission on April 1, 2002 and the Company's Quarterly Reports on Form 10-Q for the Quarters ended March 31 and June 30, 2002. 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.