Cardima Receives FDA Notification of Acceptance and Closure of Manufacturing and Quality Systems PMA Module.
FREMONT, Calif.--(BW HealthWire)--Oct. 29, 2001
Cardima(R), Inc. (Nasdaq:CRDM) -- developer of the REVELATION(TM) Tx and REVELATION(TM) Helix microcatheter systems -- announced today that it has received notification from the U.S. Food and Drug Administration (FDA) of its acceptance and closure of the manufacturing and quality systems module of the Company's pre-market approval (PMA) application for the REVELATION Tx system for treatment of atrial fibrillation (AF).
Since March 2001, Cardima has submitted four of the five required modules for its PMA application, including three pre-clinical modules and one module concerning its manufacturing and quality operations. Earlier this month, the Company announced that the FDA had accepted and closed one of the pre-clinical modules. Review of the two remaining pre-clinical modules is progressing, and Cardima is working closely with the FDA to complete the review process.
The Company believes it will complete enrollment for the pivotal clinical trial of REVELATION Tx system before the end of calendar year 2001. The fifth and final PMA module will include six-month follow-up data on patients treated in the Phase III study.
Gabriel Vegh, chairman and chief executive officer of Cardima, said, "We are very pleased that this important module has been accepted and closed by the FDA. We believe that the acceptance of this second module marks another milestone in our objective to bring the REVELATION Tx microcatheter system to market in the U.S. for the treatment of AF, and is a testament to our manufacturing, quality and regulatory groups for their dedication and hard work."
Cardima, Inc. developed the linear ablation REVELATION Tx system for the treatment of atrial fibrillation (AF), which currently is in Phase III clinical trials. Since AF afflicts an estimated 2.2 million people in the U.S. 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 pertaining to the REVELATION Tx microcatheter system demonstrated safety and promising efficacy.
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, 2000 filed with the Securities and Exchange Commission on March 22, 2001, and subsequent Form 10-Qs issued in 2001. 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.