Business Editors & Health/Medical Writers
FREMONT, Calif.--(BW HealthWire)--July 22, 2002
Cardima(R), Inc. (Nasdaq:CRDM) -- developer of the REVELATION(TM) Tx microcatheter system and the REVELATION Helix(TM) microcatheter system -- today announced that it will release its
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Cardima, Inc. developed the linear ablation REVELATION Tx system for treating atrial fibrillation (AF). Since AF afflicts an estimated 2 million people in the United States and approximately 4.5 million people worldwide, the Company believes it is a potential $6 billion market that is poorly served by current treatment alternatives. The REVELATION Tx microcatheter system is a minimally invasive, single-use system for potentially curing AF, and is believed by the Company to be at least two years ahead of other development-stage ablation therapies in the approval process. Phase I and II data for the REVELATION Tx microcatheter system demonstrated safety and promising efficacy. The Company is targeting regulatory approval for the REVELATION Tx by the end of 2002. The Company's REVELATION Helix received CE mark approval in December 2001 and has just commenced market launch in the European Union.
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 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 December 31, 2001 filed with the Securities and Exchange Commission on April 1, 2002. 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.