SOURCE: Cardima, Inc.

November 22, 2005 08:00 ET

Cardima Announces Third Quarter 2005 Financial Results

FREMONT, CA -- (MARKET WIRE) -- November 22, 2005 -- Cardima ®, Inc. (OTC BB: CRDM), developer of the REVELATION ® Tx, REVELATION ® T-Flex and REVELATION ® Helix microcatheter systems for the treatment of atrial fibrillation (AF), reported financial results for the third quarter ended September 30, 2005.

Net sales for the third quarter ended September 30, 2005 were $346,000, a 39% decrease from the same period in 2004. United States derived net sales decreased 59% to $116,000 in the third quarter of 2005, compared with $282,000 in the same period of 2004. European derived net sales increased 32% to $83,000 from $63,000 for the third quarters of 2005 and 2004 respectively. Asian market net sales decreased 34% or $77,000 to $147,000 in the third quarter of 2005 from $224,000 for the same period in 2004.

Net loss for the third quarter of 2005 decreased 58%, or $1,575,000, to $1,129,000, or $0.01 per share, compared with $2,704,000, $0.03 per share, for the third quarter of 2004. The decrease was mainly due to the June 17, 2005 Company-wide furlough and the workforce reduction in mid-August 2005 when it resumed operations. Selling, general and administrative expenses decreased by 55%, or $757,000, to $613,000 from $1,370,000 for the third quarters of 2005 and 2004, respectively. Research and development expenses decreased 80% to $198,000 in the third quarter of 2005 from $1,016,000 for the third quarter of 2004. Shares used in calculating the net loss per share increased to 101.4 million shares outstanding from 84.7 million shares due to the issuance of shares in connection with private placements since the third quarter of 2004.

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 in the USA for a Surgical Ablation System, which targets market application by cardiac surgeons to ablate cardiac tissue during heart surgery using radio frequency (RF) energy.

Cardima, Inc. continues to pursue regulatory approvals and distribution relationships in significant market opportunities worldwide. We currently have distribution agreements for various products covering eight countries with an emphasis on Europe and the Pacific Rim, and we are currently seeking a strategic transaction for our Surgical Ablation System, which received United States Food and Drug Administration 510(k) clearance for use in ablating cardiac tissue in 2003. We have arranged for warehousing capacity in Europe to support both distribution and direct customer sales. Securing FDA approval of the REVELATION® Tx remains one of our primary goals. We plan to continue to pursue U.S. regulatory approvals for the REVELATION® Tx, as well as other therapeutic products already approved in Europe and in other markets which we believe have both the clinical potential and adequate medical support structure to accept a developing technology application. We are continuing to develop broader applications of our Surgical Ablation System as a minimally invasive, stand-alone surgical procedure to treat atrial fibrillation. We cannot assure you that we will be able to obtain or maintain any necessary regulatory approvals or that, if such regulatory approvals are obtained, that we will be able to successfully market our products, or that we will be able to establish a successful distribution channel for our Surgical Ablation System.

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 pre-market 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 third quarter ended September 30, 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.

Contact Information