FREMONT, CA.--(MARKET WIRE)—June 17, 2008 -- Cardima, Inc. (OTC BB: CADM.OB - News) a medical device company focused on the treatment of Atrial Fibrillation (AF) and manufacturer of the Cardima Surgical Ablation System, has seen its products highlighted in clinical work, key meetings and studies. The technology has been scientifically proven to be capable of creating continuous, linear, transmural lesions during beating heart surgery through an entirely thorocoscopic approach.
Hawaii Medical Center East
Cardima is pleased to announce that it has begun working in close collaboration with the recently opened Afib Center at the Hawaii Medical Center East (HMCE). This hospital is a center of excellence for cardiovascular disease in Hawaii and has initiated a major program devoted to the surgical treatment of AF using a completely endoscopic approach. Jeffrey Lee, MD and his team of professionals at the Afib Center have implemented the Cardima Ablation System, providing a new safe and effective treatment option for patients with AF.
Commenting on this new collaboration, Dr. Lee said: "Based on my initial cases working with the Cardima Surgical Ablation System, I have been very impressed. We have worked with several different technologies in the past, but Cardima definitely will be our first choice for the treatment of patients with AF going forward. Hawaii Medical Center East intends to become a major Cardima training center for the West Coast as well as for physicians from Asia. We look forward to a strong working relationship with Cardima."
Hawaii Medical Center East is a key hospital located in Honolulu, Hawaii with over 490 medical staff. The Afib Center (www.hawaiimedcen.com/hmc/afib.html) has treated over 50 cases of sole Atrial Fibrillation completely endoscopically. Dr. Jeffrey Lee is board certified in cardiothoracic surgery and Clinical Associate Professor of Surgery at the University of Hawaii School of Medicine.
Dr. Li Poa: 18th World Congress Presentation
Recently Cardima’s Surgical Ablation System was presented at the 18th World Congress, World Society of Cardio-Thoracic Surgeons in Kos, Greece (May 2, 2008) by Dr. Li Poa.
Dr. Poa is the Chief of Cardiothoracic Surgery and Cardiac Surgery Program Director at Stamford Hospital, Connecticut; a major teaching affiliate of the Columbia University College of Physicians and Surgeons where he is a faculty member. Dr. Poa specializes in endoscopic cardiac access and the surgical treatment of AF and other minimally invasive techniques.
Dr. Poa’s lecture, “Surgery for lone atrial fibrillation”, included his experience with the Cardima Surgical Ablation System. The Cardima System was presented as technology that has the ability to create transmural, continuous linear lesions, using the least Invasive approach for epicardial ablation via the thoracoscopic approach. This is critical to be able to treat lone AF, decrease patient procedure time and post-operative recovery time.
Dr. Adam Saltman: Surgical Study Published
Dr. Adam Saltman's paper, "Histopathological Evaluation of a Novel Radiofrequency Surgical Ablation System" an evaluation of the Cardima Surgical Ablation System has been published in Innovations • Volume 3, Number 2, March 2008, the Journal of the International Society of Minimally Invasive Cardiothoracic Surgery. This paper concludes the Cardima Surgical Ablation System produces histolgically transmural lesions and is applicable to beating heart thorocoscopic surgery. This paper is an important corroboration of the ability of the Cardima Surgical Ablation System to create long transmural lesions using minimally invasive surgical techniques in a safe and effective manner. Dr. Saltman commented as follows, "My work with the Cardima Surgical Ablation System indicates that the System can be used as an effective tool for the surgical ablation of atrial fibrillation using a minimally invasive thorocoscopic approach."
Dr. Saltman is a trained cardiothoracic surgeon who currently practices at Maimonides Medical Center in New York.
Dr. Mark La Meir: University of Maastricht
Dr. Mark La Meir, a well known cardiothoracic surgeon who teaches at the University of Maastricht, located in the Netherlands, has conducted an aggressive animal study using the Cardima Surgical Ablation System. Based on his findings, he concurs the Cardima Surgical Ablation System is able to produce highly transmural lesions. Cardima and Dr. La Meir intend to continue working together on further studies with the intention of presenting scientific medical data to the European medical community. Dr. La Meir commented on his recent work with Cardima, "I was very impressed by the Cardima Surgical Ablation System and its ability to make long, transmural lesions. We are looking forward to working closely with Cardima to conduct further research as well as treating lone AF patients at our center."
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.
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.