Cardima Meets with FDA Regarding Revelation TX PMA.

FREMONT, Calif. -- Cardima(R), Inc. (Other OTC: CRDM.PK), announced that on June 10th Cardima met with the Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) to continue the process towards seeking approval for the REVELATION(R) Tx ablation catheter for treatment of atrial fibrillation (AF).

The pre-market approval application (PMA), which was previously submitted in June 2003 and amended in January 2004, includes phase III data obtained by treating self-terminating AF. Trial data indicated substantial and statistically significant improvements were realized almost uniformly for all measured arrhythmia symptoms as well as for quality-of-life measures. The study demonstrated that the addition of right atrial catheter ablation to a regimen of previously ineffective antiarrhythmic drugs (AADs) yields a significant reduction in the frequency, duration and severity of AF episodes and symptoms. Of the ninety-three subjects included in the trial, eighty-four subjects (90%) provided six-month AF episode frequency data. This data demonstrated a significant decrease in symptomatic frequency when compared to baseline. In addition, forty-nine subjects (58%) were considered a clinical success by protocol definition.

The focus of this latest meeting was to exchange views on each other's positions and to discuss the issues stated in the May 21, 2004, and the June 26, 2003, FDA non-approvable letters. No conclusions were reached at the end of the three-hour meeting, but both sides agreed to continue the dialog. The parties have not set a date for a follow-up meeting. Cardima believes that the data submitted in January 2004 in an amended PMA for the REVELATION Tx provides sufficient support for safety and effectiveness to reduce symptomatic AF burden and improve the quality of life of patients suffering from self-terminating but very uncomfortable atrial fibrillation within the least burdensome guidelines of the FDA.

Gabriel B. Vegh, Chairman and CEO stated, "We are encouraged by this opportunity to have an extended discussion on specific issues and remain optimistic about gaining the approval for the REVELATION Tx."

As previously announced, a non-approvable letter was received by Cardima on May 28, 2004, and it informed Cardima that the FDA had determined that Cardima's REVELATION Tx Microcatheter with NavAblator(R) Ablation System PMA was not approvable based on applicable regulatory requirements. The letter indicated that the FDA believed that collecting additional data using a revised study design would be the least burdensome approach to demonstrate the device's safety and effectiveness. At a meeting on June 18, 2004, the FDA reiterated its view, as stated in its non-approvable letter, that data from an additional study would be necessary to demonstrate the effectiveness of the REVELATION Tx for atrial fibrillation. The FDA representatives stated that the nature of the trial's primary goal, reduction in the number of AF episodes after ablation, would require a randomized clinical trial design.

About Cardima

Cardima, Inc. has developed the REVELATION Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheters, the NAVIPORT deflectable guiding catheters, and the INTELLITEMP energy management system for the minimally invasive treatment of atrial fibrillation (AF. The REVELATION Tx, REVELATION T-Flex and REVELATION Helix systems and the INTELLITEMP have received CE Mark approval in Europe. The Company has also developed and obtained approval for in the USA a Surgical Ablation System, which targets market application by cardiac surgeons to ablate cardiac tissue during heart surgery using radio frequency (RF) energy.

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 premarket approval application for the REVELATION Tx, including the ramifications of our recent meeting with the FDA, the prospect for any future clinical trials or regulatory activities, the Company's ability to obtain funding under the Agility loan facility, the risks associated with the Agility 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, 2004, the Company's Quarterly Report on Form 10-Q for the first quarter ended March 31, 2005, 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.