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Cardima Appoints a Medical Director to Its Management Team
Tuesday October 21, 8:30 am ET
FREMONT, Calif.--(BUSINESS WIRE)--Oct. 21, 2003--Cardima®, Inc. (NasdaqSC: CRDM) has appointed Daniel Joseph Cher, M.D. to fill a newly created position of Medical Director reporting to the Chief Executive Officer ("CEO"). This position is a first of this kind for Cardima and it is intended to strengthen Cardima's presence in regulatory and clinical activities worldwide.
"The creation of this position and the appointment of Dr. Cher comes at an exciting time for Cardima," said Gabriel Vegh, CEO of Cardima. "Dr. Cher has over 10 years of cumulative industry experience in the areas of healthcare consulting, data analysis and biostatistics and clinical medicine. We anticipate that he will be able to provide leadership in determining best strategies for evaluating, developing, and achieving approval for both new and existing products. His most recent experiences appears to fit nicely with our current requirements."
Prior to joining Cardima, Dr. Cher served as Managing Scientist at Exponent Failure Analysis, a consulting company providing engineering, health and environmental research and scientific support to a variety of clients. At Exponent Dr. Cher was responsible for managing scientific consultation projects in the areas of clinical trial design and analysis for several large and small device companies, managed care claims analysis, a novel company-wide Web-enabled database access software application and various projects in occupational health. This combined experience allowed him to play an instrumental role in obtaining a PMA approval for Essure,(TM) an implant aimed a permanent female sterilization manufactured by Conceptus Inc. (San Carlos, CA) With Conceptus, Dr. Cher was the primary consulting biostatistician and clinical advisor, handling all written and oral communications with the FDA having to do with analytic and statistical approaches and results. Dr. Cher accompanied Conceptus to FDA on several occasions and has accompanied other medical device companies to FDA to enable discussion of alternative statistical approaches to clinical trial design and analysis. Prior to entering the consulting industry, Dr. Cher practiced medicine at the VA Medical Center in Palo Alto, CA. Dr Cher completed his undergraduate studies at Stanford University and earned his M.D. at Yale University. He has authored numerous journal articles and letters.
Commenting on his appointment, Dr. Cher said, "Over the past few years, it appears that Cardima has become a serious player in the race to find a curative solution for AF. The technology platform is exciting because it can be applied across a broad spectrum of medical practice. There appears to be a strong following from a core of enthusiastic clinicians who have both participated in controlled clinical studies and forged leadership positions in emerging market opportunities". I am looking forward to working closely with the management team at Cardima and playing a role in the direction of its ongoing clinical, scientific and strategic programs."
About Cardima
Cardima, Inc. has developed the REVELATION® Tx, REVELATION T-Flex and REVELATION Helix linear ablation microcatheter systems 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 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 are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those expressed in or contemplated by such forward-looking statements. Potential risks and uncertainties include difficulties inherent in predicting the safety and effectiveness of the Surgical Ablation System based on the small number of cases to date, the Company's ability to raise additional capital, whether the Company's premarket approval application will be approved by the U.S. FDA, and whether the Company will be able to conduct successful clinical trials, obtain and maintain regulatory approvals, gain acceptance from the marketplace for its products, secure distribution partners or successfully market, sell and distribute its products to end users in the United States, in the event FDA approval is obtained, or in other markets. Additional risks are set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2002, filed with the Securities and Exchange Commission on March 31, 2003, and the Company's Quarterly Reports on Form 10-Q, as amended, for the quarters ended March 31 and June 30, 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.