SOURCE: Cardima, Inc.

June 30, 2008 08:45 ET

Cardima, Inc. Receives Chinese State Food and Drug Administration (SFDA) Approval to Market the INTELLITEMP® Energy Management Device in the People's Republic of China

FREMONT, CA--(Marketwire - June 30, 2008) - Cardima, Inc. (OTCBB: CADM) Cardima has been granted a market access license for the INTELLITEMP® by the SFDA and it is the first multichannel radiofrequency (RF) energy delivery device to receive approval for sale in China. The Company was previously awarded an INTELLITEMP patent by the State Intellectual Property Office in 2003.

Existing RF delivery systems currently marketed in China can deliver energy to only one ablation electrode at a time. The INTELLITEMP controls the delivery of RF energy for effective multi-electrode linear ablation in Cardima's systems, namely, the EP Ablation System and the Surgical Ablation System, both designed to treat atrial fibrillation ("AF"). Other Cardima products pending China SFDA approval are the EP ablation catheters and Surgical Ablation Probes.

The INTELLITEMP controls RF energy delivery to any combination of up to 8 electrodes simultaneously along a specially designed Cardima EP catheter or surgical probe. In comparison to standard "drag and burn" ablation technologies, employing the INTELLITEMP in combination with a Cardima linear ablation catheter or surgical probe produces lesions that have penetrating depth, without gaps along a linear trajectory. These are key elements in delivering effective clinical results.

Cardima's CEO, Robert Cheney, commented: "We are delighted to have received approval from the SFDA. This is a significant milestone for Cardima. China is one of Cardima's primary target markets with a large aging population that can benefit from the effective treatment of AF using a multi-electrode linear ablation system, like Cardima's. We are well positioned to enter the China market having already taken the initiative to establish relationships with leading physicians and institutions involved in the treatment of AF."

A 2004 study from Peking University estimates that AF currently affects approximately 10 million patients in China. Published scientific literature in China shows that the percentage of hospital admissions for AF has increased at a faster rate than for cardiovascular admissions generally. As in other countries, the distribution of AF events in China progressively increases with age. China's population of people over the age of 50 will be 332 million in 2010 and will increase to 525 million by 2025, according to the International Institute for Applied Systems Analysis. Studies also show that the incidence of stroke among AF cases is high in China, yet it is difficult to enforce a drug regimen for preventing stroke in this patient population. Therefore, it will be a significant challenge for the public healthcare system in China to manage, control and treat the growing numbers of AF patients. China is one of the world's fastest growing medical markets and holds a high regard for medical products manufactured in the United States and Europe.

The INTELLITEMP is marketed in the U.S.A. as part of the Cardima Surgical Ablation System. It is CE Marked in the EU as a component of both the Cardima Surgical and EP Ablation Systems.

About Cardima

Cardima, Inc. has developed the PATHFINDER®, TRACER® and VUEPORT® Series of diagnostic catheters, the NAVIPORT® Series of guiding catheters, the REVELATION® Series of ablation catheters, the Surgical Ablation System with its series of ablation probes, and the INTELLITEMP® Energy Management Device Series for RF (radiofrequency) energy management. These devices are CE marked and/or received United States FDA 510(k) clearance. The REVELATION Series of ablation catheters with the INTELLITEMP EP Energy Management Device was developed and marketed for the treatment of atrial fibrillation (AF) with CE mark approval in Europe; it is not yet commercially approved in the United States.

For more information, please visit the Company's website at

The PATHFINDER®, TRACER®, VUEPORT®, NAVIPORT®, REVELATION® and INTELLITEMP® are registered trademarks of Cardima, Inc.

Forward-Looking Statements

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, including but not limited to the employment of Cardima's INTELLITEMP in combination with a Cardima linear ablation catheter or surgical probe produces lesions that have penetrating depth, without gaps along a linear trajectory. Potential risks and uncertainties include, but are not limited to: the uncertainties associated with the prospects for FDA approval of any new devices; the prospect for any future clinical trials or regulatory activities; 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 FDA approval for the EP ablation applications in the USA and CE mark for the Surgical Ablation probe series with Sheath. Additional risks and uncertainties are set forth in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2007, the Company's Quarterly Report on Form 10-QSB and in the Company's other filings with the Securities and Exchange Commission. 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.

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