美国CryoLife, Inc
Founded in 1984, CryoLife, Inc. was the first biomedical company to commercially develop low temperature preservation of implantable human tissues for cardiac and vascular surgical reconstruction. Today, in addition to our ongoing advancements in tissue preservation, the company pioneers research in the development of implantable biological devices, surgical adhesives, and biomaterials for use in cardiac, vascular, general and reconstructive surgery.
SynerGraft®, another proprietary technology developed by CryoLife, is designed to remove cells and cellular remnants from tissues without compromising the integrity of the underlying collagen matrix. In February 2008, we received FDA clearance to market CryoValve SG, a human pulmonary heart valve developed using SynerGraft technology, that is used for RVOT (right ventricular outflow tract reconstruction) and the Ross Procedure. This is the first decellularized cardiac tissue to be cleared by the FDA.
The SynerGraft technology has also been successfully applied to cross-species animal tissues resulting in a vascular access graft for kidney dialysis patients that does not require immunosuppression therapy of the patient or chemical cross-linking of the tissue to make it biocompatible. This product is available only in international markets.
In early 2008, CryoLife licensed a kidney transport technology from Trophic Solutions, LLC, a small Madison, Wisconsin company founded by three scientists from the University of Wisconsin. In early animal and human testing, the technology doubles the time, from three to six days, that kidneys can be held in cold storage without mechanical pumping. In late 2008, after completion of further evaluation, we will begin human testing of the transport solution under an FDA-controlled clinical trial.
Since 1984, CryoLife has preserved hundreds of thousands of human cardiac and vascular tissues that have provided life- and limb-saving options to women and men of all ages, including tiny infants. BioGlue our surgical adhesive, has been used in more than 450,000 surgical procedures since its introduction in international markets in 1998 and in the U.S. in December 2001.
CryoLife has been, and continues to be, a leader in the emerging fields of tissue engineering, surgical adhesives, and implantable biomaterials. We strongly believe that the successful preservation and transplantation of human tissues, cells, and biomaterials offer great promise for treating many of the birth defects and diseases we face today. At CryoLife, we are proud of what we have accomplished so far, and we look forward to even greater achievements in the future.