Cardima Reports Completion of Left-Sided Atrial Fibrillation Study; Expands European Study to Three Sites.

Business Editors & Health/Medical Writers

FREMONT, Calif.--(BW HealthWire)--Sept. 5, 2001

Plans European Filing for Treating AF Originating

in the Pulmonary Veins of the Heart Before Year End

Cardima(R), Inc. (NasdaqSC:CRDM) announced today the completion of a five-patient study with its REVELATION(TM) Helix(TM) radiofrequency (RF) ablation microcatheter for the treatment of atrial fibrillation (AF) originating in the pulmonary veins of the heart.

Cardima's initial European study was conducted at the University of Bonn, Department of Medicine -- Cardiology, Bonn, Germany.

Headed by Prof. Dr. Berndt Luderitz, University of Bonn, Dr. Thorsten Lewalter and his team successfully treated all the patients suffering from AF using the REVELATION Helix catheter. To date, no complications have been reported. The procedures all required a trans-septal approach to access the left side of the heart, detailed mapping and RF delivery in the pulmonary veins. The REVELATION Helix combines the ability to both map and ablate with a unique helical-shaped catheter tip. The current technique requires at least two catheters in the left atrium, usually one catheter to map and a second catheter to ablate.

"The (Revelation Helix) catheter exhibited excellent handling characteristics and an adequate mixture of flexibility and stability for maneuvering in and around the pulmonary veins in the left atrium, allowing mapping of electrical potentials and safe ablation," said Dr. Lewalter. "In all of our procedures, we found that the REVELATION Helix allowed circumferential mapping and `focal' ablation using a single left atrial catheter approach, thus reducing the risk of complications. All patients have left the hospital in stable sinus rhythm and started their six-month follow-up program as part of this clinical study."

Due to the preliminary success of the study, Cardima has expanded its European study of the REVELATION Helix to two other sites in Germany, including the University of Munich, under the auspices of Prof. Dr. C. Schmitt, and the University of Hamburg, under the auspices of Dr. S. Willems.

Gabriel Vegh, chief executive officer of Cardima, Inc., stated, "We are extremely pleased with the successful outcome of this first five-patient study using the REVELATION Helix in Bonn. This small, coiled-electrode microcatheter is the culmination of several years of developmental effort at Cardima, yielding first the Pathfinder mapping devices, then the REVELATION Tx therapeutic linear ablation system and now the REVELATION Helix, each incrementally evolving from the previous model. We are planning to seek regulatory approvals in Europe for the treatment of AF originating in the pulmonary veins of the heart before the end of 2001."

The REVELATION Helix is currently only available for this European study and is not commercially available in the U.S.

Cardima, Inc. developed its patented, unique series of REVELATION microcatheter systems for the mapping and treatment of AF, which the Company believes is a potential $6 billion market that is poorly served by current treatment alternatives. AF afflicts an estimated 4.5 million people worldwide. The REVELATION series of microcatheters is a minimally invasive, single-use microcatheter for potentially curing AF. Cardima has a Phase III study underway in the U.S. for its Revelation Tx linear ablation microcatheter system, which is expected to be completed in the second half of 2001.

Except for the historical information contained herein, the matters discussed in this news 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 Dec. 31, 2000 and Quarterly Reports on Form 10-Q for the quarters ended March 31 and June 30, 2001, filed with the Securities and Exchange Commission on March 22, May 14 and August 14, 2001, respectively. 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.