MedicalCV’s ATRILAZE(TM) and SOLAR(TM) Systems Highlighted at 10th Annual NewEra Cardiac Care 2007 Meeting
MedicalCV, Inc. (OTCBB:MCVI), a cardiovascular surgery company, announced today that both the Company’s ATRILAZE surgical ablation system and SOLAR automated surgical ablation system were highlighted at this weekend’s NewEra Cardiac Care 2007 meeting on Saturday, January 6th, at the Hyatt Regency in Huntington Beach, California. Together, these systems represent two generations of the Company’s current laser-based tissue ablation platform; the ATRILAZE System, which presently has FDA 510(k) clearance for cardiac tissue ablation, and the SOLAR System, the application for which is in the process of being amended to seek a 510(k) clearance for soft tissue ablation from the FDA.
The first presentation was made by Baron L. Hamman, MD, a cardiovascular surgeon from Baylor University Medical Center in Dallas, TX. Dr. Hamman discussed the mid-term results of a small, retrospective study of the Company’s ATRILAZE™ System for cardiac tissue ablation in concomitant open-heart surgical procedures during a poster session Saturday afternoon.
Adam. E. Saltman, MD, PhD, a cardiovascular surgeon from Maimonides Medical Center in Brooklyn, New York, made the second presentation, also on Saturday afternoon. Dr. Saltman, who studied the Company’s SOLAR automated surgical ablation system in a pre-clinical setting, described the system’s ability to create transmural, or full-thickness, tissue lesions. Many surgeons consider transmurality to be essential in performing successful tissue ablations.
“It is gratifying that two generations of our laser-based tissue ablation platform were discussed at what has become a leading forum for cardiac surgeons,” stated Marc Flores, President and Chief Executive Officer of MedicalCV. “We are honored to be working with both Dr. Hamman and Dr. Saltman as they are not only recognized as skilled clinicians and researchers but acknowledged as thought leaders in minimally invasive cardiac surgery as well. It is a true privilege to have them serve on our Scientific Advisory Board.”
NewEra Cardiac Care 2007 was the tenth in a series of annual conferences offering cardiac-care professionals a discussion forum for both current and future state-of-the-art techniques and technologies for treating and managing cardiac disease. The conference, which was co-sponsored by the University of California, Irvine, School of Medicine and Aligned Management Associates, ran Friday, January 5th through Sunday, January 7th.
About MedicalCV, Inc.
MedicalCV’s ATRILAZE surgical ablation system utilizes laser energy for cardiac tissue ablation in both open-heart and minimally invasive cardiac surgery procedures. Physicians see precise cardiac ablation as a potentially effective way to address atrial fibrillation in certain patients. Atrial fibrillation, or AF, is the most commonly occurring cardiac arrhythmia. It reduces cardiac output, is a major precursor to congestive heart failure and is associated with an increased incidence of stroke.
MedicalCV’s SOLAR automated surgical ablation system, which is subject to FDA clearance, utilizes laser energy to ablate soft tissue in various surgical settings.
This release contains certain forward-looking statements of expected future developments, as defined in the Private Securities Litigation Reform Act of 1995. The forward-looking statements in this release refer to the Company’s expectations regarding the development, regulatory clearance and commercialization of its automated surgical ablation system. These forward-looking statements reflect management’s expectations and are based on currently available data; however, actual results are subject to future risks and uncertainties, which could materially affect actual performance. Risks and uncertainties that could affect such performance include, but are not limited to, the following: the Company’s ability to fund significant capital needs; the ability to gather acceptable clinical data in a timely manner to support regulatory clearances; the ability of the Company’s capital goods suppliers to provide it with suitable clinical product; competing technological and market developments; physician acceptance of the Company’s cardiovascular products; dependence upon governmental reimbursements and third party suppliers; and the strength of the market for cardiovascular products. For more detailed information about these risks and uncertainties, please review the Company’s Annual Report on Form 10-KSB, as filed with the Securities and Exchange Commission on July 20, 2006.
These events and uncertainties are difficult or impossible to predict accurately and many are beyond the Company’s control. The Company assumes no obligation to publicly release the results of any revisions that may be made to any forward-looking statements to reflect events or uncertainties after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.