| Corporate Profile |
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Founded in 1984, CryoLife was the first biomedical company in the world to commercialize the low temperature preservation of human implantable tissues for complex cardiac and vascular reconstruction. Today, in addition to our ongoing advancements in tissue preservation, the company pioneers research in the development of implantable biological devices, surgical adhesives, hemostatic agents and biomaterials for use in cardiac, vascular and general surgery. 
The company’s corporate headquarters is in suburban Atlanta, Georgia, where its 200,000 square foot, 21 acre, corporate campus is home to the company’s tissue preservation laboratory and surgical adhesive manufacturing facility. The corporate headquarters features a 3,600 square foot auditorium as well as “wet lab” facilities for hands-on surgical training for physicians. Since the company’s inception, cardiac tissues it has preserved have been used to reconstruct hearts in about 60,000 patients; more than half of those patients have been children. The company believes that more than 30,000 people have received preserved human vascular grafts for limb-saving peripheral vascular reconstruction. The company also sells BioGlue® Surgical Adhesive. Since BioGlue’s successful introduction into European markets in 1998 and then into the U.S. in 2001, this product has been used in more than 500,000 surgical procedures worldwide. In February 2008, the company received FDA clearance to market CryoValve® SG, a human pulmonary heart valve, used for RVOT (right ventricular outflow tract) reconstruction and the Ross Procedure, is processed using CryoLife’s proprietary SynerGraft® technology. The SynerGraft technology, developed and patented by CryoLife, is designed to remove cells and cellular remnants from tissues without compromising the integrity of the underlying collagen matrix. The CryoValve SG is the first decellularized human cardiac tissue to be cleared by the FDA.
In August 2009, the company received 510(k) clearance from the FDA to market its CryoPatch® SG pulmonary human cardiac patch throughout the United States. The CryoPatch SG is processed with the Company’s proprietary SynerGraft® technology designed to remove allogeneic donor cells and cellular remnants from tissue without compromising the integrity of the underlying collagen matrix. This preserved tissue is indicated for the repair or reconstruction of the right ventricular outflow tract (RVOT) which is a surgery commonly performed in children with congenital heart defects. I feel that the introduction of CryoPatch SG represents another step in the broadening applications of the SynerGraft technology to additional human tissues and cells. CryoPatch SG may offer an attractive tissue reconstruction option for many children born with heart defects. For a more detailed discussion of the company’s history, products and services you may go to CryoLife’s website home page and view or request a copy of the 25th anniversary booklet that features a few of the patients and their doctors who have had their lives enhanced with CryoLife preserved tissues and in some cases our biological adhesives and glues. Steven G. Anderson |
In July 2009, the company received a CE Mark approval for BioFoam® Surgical Matrix. The CE Mark allows immediate unrestricted commercial distribution throughout the 27 nation European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) where conventional hemostatic methods have proven to be ineffective or impractical. BioFoam, a protein hydrogel biomaterial, is the second product in this technology platform to receive a CE Mark (the first was BioGlue). BioFoam contains an expansion agent mixed with a material that creates a mechanical barrier to decrease blood flow resulting in a porous matrix that allows blood to enter, leading to cellular aggregation and enhanced hemostasis.