Cardima Achieves Major Milestone for Its Surgical Ablation System as Lenox Hill Hospital Completes Two 'Less Invasive' Procedures to Treat Atrial Fibrillation.

Business Editors/Health/Medical Writers

FREMONT, Calif.--(BUSINESS WIRE)--May 4, 2004

Marking a major first for Cardima(R), Inc.'s (NasdaqSC: CRDM) Surgical Ablation System (SAS), doctors at Lenox Hill Hospital in New York City, New York reported two successful "less invasive" cases using the system to treat atrial fibrillation (AF). Cardima's SAS ablates cardiac tissue during heart surgery using radio frequency (RF) energy.

Didier F. Loulmet, M.D., Chief of the Minimally Invasive Robotic Cardiac Surgery Program, and head of the Atrial Fibrillation Program for Lenox Hospital, began using the Cardima SAS last year during "open chest" procedures to treat chronic AF in patients who required direct valve repairs. An open chest procedure involves cutting through the sternum where the rib cage comes together in the middle of the chest. This allows the surgeon to "open" the chest to have direct visual access to the heart. The opening is about 4 to 6 inches long and about 4 to 5 inches wide. A "less invasive" procedure gains access to the heart by making a much smaller cut between the ribs, which creates an opening about 2 inches long and only 3/4 to 1 inch wide. This is called a mini thoracotomy and typically allows faster recovery because it does not involve healing of bone. Less invasive procedures such as a mini thoracotomy are limited to the use of small profile devices such as the Cardima SAS. Dr. Loulmet recently applied the Cardima Surgical Ablation technology in two AF cases during a mini thoracotomy, or "less invasive" approach.

Dr. Loulmet, commented, "The unique technology behind the Cardima Ablation System proved to be a critical and powerful tool for this 'less invasive' approach. The ease of use, power, and depth of penetration is impressive. Because Cardima's SAS is flexible and has a very low profile, it allows multiple opportunities to access the heart to treat AF. This unique versatility gives us the ability to use this technology on both the 'open' and the 'less invasive' procedures. This is a plus when addressing the needs of cardiac surgeons faced with the treatment of atrial fibrillation."

"We are pleased to learn that Cardima SAS technology performed well during this 'less invasive' surgical approach," said Gabriel Vegh, Chief Executive Officer of Cardima. "This minimally invasive approach marks an important milestone in the future treatment of AF - opening the door to the prospect of our technology being broadly used in a stand alone procedure to treat all patients affected by atrial fibrillation."

Cardima's Ablation System received 510(K) approval by the U.S. Food and Drug Administration (FDA) on February 4, 2003, to ablate cardiac tissue during heart surgery via the use of radio frequency (RF) energy.

The Cardima Ablation System uses commercially available surgical radio frequency generators, a Cardima Surgical Probe with multi-electrode linear array microcatheter technology similar to the Company's REVELATION(R) Tx, and a novel power-channeling device developed by Cardima, the INTELLITEMP(TM), which allows RF energy to be applied to any single, any multiple, or all electrodes on the probe, simultaneously. The Surgical Ablation Probe is also deflectable, allowing surgeons the flexibility to create lesions in various shapes as needed to complete the procedure effectively.

The Company believes that the Cardima Ablation System can significantly reduce the time required to form lesions and can sense tissue temperature interactively to ensure lesions are uniform, thin and linear. This system is part of Cardima's AF strategy, which is to develop tools to treat patients suffering from irregular heart rhythms.

About Cardima

Cardima, Inc. has developed the REVELATION(R) 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 Helix was developed for the treatment of AF originating in the pulmonary veins of the heart. 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 a Surgical Ablation System, which is expected to be used by cardiac surgeons to treat AF by ablating cardiac tissue during heart surgery using radio frequency (RF) energy. In February 2003, the Company announced that it had received FDA 510(k) clearance to market the Surgical Ablation System in the U.S.

Except for the historical information contained herein, the matters discussed in this press release, including the Company's belief about its ability to fund operations, 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 Company's ability to raise additional capital, whether the Company's pre-market approval (PMA) application for the REVELATION(R) Tx or any other product will be approved by the FDA and whether the approval process will require unanticipated expenses, the possibility of business disruption or unanticipated expenses due to the Company's recent staffing reduction and financing efforts, and whether the Company will be able to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance for its products from the marketplace, secure distribution partners or successfully manufacture, market, sell and distribute its products to end users in the event regulatory approvals are obtained. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2003. 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.