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The Ross Summit 2010 to Focus on New Survival Data, Technique Refinement and Availability of the Procedure

October 12, 2010

ATLANTA, Oct. 12 /PRNewswire/ — More than 100 cardiovascular surgeons and cardiologists from 25 countries are scheduled to attend the third annual global Ross Summit, a two-day surgical congress focused on the Ross Procedure. Filled with a number of point-counterpoint discussions, the forum will feature the presentation of much new data about the Ross Procedure and interactive discussions among many of the world’s elite cardiovascular surgeons and cardiologists regarding survival, quality of life, technique refinement and availability of the procedure to the patients who best benefit from it.

CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, will convene the summit at its corporate headquarters training facility in suburban Atlanta Oct. 15 and 16.

“Currently, the Ross Procedure is performed on about 1,500 individuals globally each year. Perhaps the most important advantage of the procedure is growing evidence of improved long-term survival and quality of life over other valve replacement options,” said Dr. William Northrup III, vice president of physician relations and education at CryoLife. “The procedure is also attractive because patients who undergo the procedure do not have to take long-term anticoagulant medications after surgery and experience no restrictions in physical activity. Historically, there has been much discussion regarding the survival data and the impact of patient selection on the data. The Ross Summit always provides a balanced opportunity for interactive discussion after each presentation. Of particular interest this year will be presentations and discussions surrounding data for patients into the second decade following their Ross Procedure.”

Pioneered in 1967, the Ross Procedure is a type of specialized aortic valve surgery in which the patient’s diseased aortic valve is replaced with his or her own pulmonary valve. The pulmonary valve is then typically replaced with a cryopreserved human pulmonary valve. The procedure is a complex surgical technique that is usually performed in specialized centers by surgeons who have developed specific expertise with the procedure. As a result, one of the Summit’s sessions will focus on increasing the availability of the procedure to the patients for whom it is best suited by increasing awareness in the cardiologist community and by mentoring the next generation of Ross surgeons.

Led by Professor Sir Magdi Yacoub, FRS, FRCS, of Imperial College’s Heart Science Center in London in tandem with Dr. Northrup, The Ross Summit also includes two afternoons of hands-on mentored instruction in the various techniques of this specific form of cardiac reconstruction utilizing biological simulators. A full faculty list and summit agenda can be found at www.cryolife.com/about/events/hosted/therosssummit.

“Things are constantly changing, evolving and improving within the Ross Procedure community,” noted Steven G. Anderson, chairman, president and CEO of CryoLife. “It’s why CryoLife hosts the Ross Summit annually. The interaction and perspective from peers and the continued sharing of new data have proven valuable to this elite group of cardiothoracic surgeons as evidenced by the repeat registrations each year.”

A decellularized human pulmonary heart valve, CryoValve® SG, processed using CryoLife’s SynerGraft® technology, was cleared by the FDA in February 2008 for use in cardiac reconstruction procedures such as the Ross Procedure.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company’s CryoValve® SG pulmonary heart valve, processed using CryoLife’s proprietary SynerGraft® technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The Company’s CryoPatch® SG pulmonary cardiac patch has FDA 510(k) clearance for the repair or reconstruction of the right ventricular outflow tract (RVOT), which is a surgery commonly performed in children with congenital heart defects, such as Tetralogy of Fallot, Truncus Arteriosus, and Pulmonary Atresia. CryoPatch SG is distributed in three anatomic configurations: pulmonary hemi-artery, pulmonary trunk and pulmonary branch. The Company’s BioGlue® Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company’s BioFoam® Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. In late September, CryoLife entered into a distribution agreement for PerClot®, an absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community. CryoLife currently distributes HemoStase®, a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in many international markets for cardiac, vascular, and general surgery, subject to certain exclusions, although CryoLife has received notice from Medafor, Inc. that it has terminated its HemoStase distribution agreement with CryoLife.

Statements made in this press release that look forward in time or that express management’s beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding the growing evidence of improved long-term survival and quality of life associated with the Ross Procedure over other valve replacement options. These future events may not occur as and when expected, if at all, and, together with the Company’s business, are subject to various risks and uncertainties. These risks and uncertainties include that the evidence of the benefits associated with the Ross Procedure may not continue to grow, the evidence is based, in part, on studies that have not been peer-reviewed, and the validity of the data underlying the evidence and/or the conclusions drawn from the data may be challenged and are subject to interpretation. Also, long-term survival rates and quality of life for patients could change, as many patients who have undergone the Ross Procedure are still in the early stages of recovery. If confidence in the benefits associated with the Ross Procedure was to dissipate in the cardiovascular surgeon community, the number of CryoValve SG heart valves shipped by CryoLife could be significantly reduced, which in turn could have a material adverse affect on CryoLife’s revenues, financial position and results of operation. CryoLife’s business is also subject to a number of risks and uncertainties, including the risk factors detailed in our Securities and Exchange Commission filings, including our Form 10-Q filing for the quarter ended June 30, 2010, our Form 10-Q filing for the quarter ended March 31, 2010 and our Form 10-K filing for the year ended December 31, 2009, and the Company’s other SEC filings. The Company does not undertake to update its forward-looking statements.

For additional information about the Company, visit CryoLife’s Web Site: http://www.cryolife.com.

SOURCE CryoLife, Inc.


Source: newswire



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