Healthcare Industry News: Surgical Ablation
News Release - February 22, 2008
Cardima Announces Appointment of Dr. Sanjeev Saksena to Scientific Advisory Board as FDA Regulatory ConsultantFREMONT, CA--(Healthcare Sales & Marketing Network)--Feb 22, 2008 -- Cardima, Inc. (OTC BB:CADM.OB ) announced the appointment of Dr. Sanjeev Saksena to its Scientific Advisory Board as an FDA Regulatory Consultant. Dr. Saksena is a trained Cardiologist and Cardiac Electrophysiologist with an international reputation; he has published extensively and lectured internationally. Dr. Saksena's role as Clinical Trial Study Chair will be to support the FDA approval process for Cardima's EP Ablation System for the treatment of Atrial Fibrillation ("AF").
In commenting on Dr. Saksena's appointment, Cardima's CEO, Mr. Cheney, said, "Cardima is indeed fortunate to have a physician of Dr. Saksena's extensive experience and worldwide reputation to assist our team of professionals prepare the necessary clinical data to support FDA approval for our EP products in the treatment of AF."
Dr. Saksena is Clinical Professor of Medicine at UMDNJ-Robert Wood Johnson School of Medicine, and Medical Director of the Electrophysiology Research Foundation. He has been the Director of the Cardiovascular Institute comprised of the Divisions of Cardiology and Cardiac Surgery at PBI Regional Medical Center from 1999-2004 and Director of the Arrhythmia & Pacemaker Service from 1989. He has been President of the North American Society of Pacing and Electrophysiology (NASPE/HRS) and Chair of its Government Relations Committee. He is currently a member of the governmental affairs committees for the Heart Rhythm Society and the American College of Cardiology.
Dr. Saksena played a key role in the growth of the cardiology and cardiac surgery departments in his institutions as well as the restructuring of national organizations such as NASPE to the Heart Rhythm Society. Dr. Saksena has participated in many clinical trials and has contributed extensively to leading edge academic research in the field of cardiology.
As one of the world's leading experts in the field of Cardiology and Electrophysiology, Dr. Saksena is the Founding editor and current Editor-in-Chief of the Journal of Interventional Cardiac Electrophysiology, has been the Editor of the Government Relations column for PACE and remains an active consultant to governmental and private health care organizations. He has been an active clinical and applied basic science investigator since 1980, and has held grants from the NHLBI industry and the American Heart Association. In this period, he has authored/co-authored over 350 abstracts, 250 articles, and 60 book chapters. He is editor/co-editor of 4 journal supplements and co-editor of 5 books and has most recently co-edited a new textbook titled "Electrophysiological Disorders of the Heart."
The entire Board of Directors welcomes Dr. Saksena's appointment.
Cardima, Inc. has developed the PATHFINDER® and REVELATION® Series of diagnostic catheters, the INTELLITEMP® Energy Management Device, and the Surgical Ablation System (SAS). All of these devices are CE marked and received U.S. 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) after receiving CE mark approval in Europe; it is not currently available in the U.S.
For more information, please visit the Company's website at www.cardima.com.
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 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 a strategic transaction involving the Surgical Ablation System. Additional risks and uncertainties are set forth in the Company's Annual Report on Form 10-KSB for the year ended December 31, 2006, the Company's Quarterly Report on Form 10-QSB for the third quarter ended September 30, 2007, 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.
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