Founded in 1984, CryoLife was the first biomedical company to specialize in the ultra-low temperature preservation of human heart valves used for cardiac reconstruction, primarily in children born with heart defects. Since those initial efforts, the company’s preservation technology has been expanded to include the preservation of human saphenous and femoral veins and aorto-iliac vessels for peripheral and central vascular reconstruction procedures. The company’s proprietary processes for preserving these cardiovascular tissues have dramatically improved and enhanced the lives of tens of thousands of patients, primarily in North America.

In 1996, the company acquired the initial patents and technology for a surgical adhesive, BioGlue^®, a protein hydrogel polymer, from its inventor Nicholas Kowanko, Ph.D. After three years of product development and testing, it received a CE Mark approval for all countries in the European Community. In 2001, BioGlue received FDA approval for distribution in the U.S. Since its introduction, BioGlue has been used in excess of an estimated 615,000 surgical procedures worldwide.

The company’s protein hydrogel technology platform was expanded in 2009 with the CE Mark approval of BioFoam^® Surgical Matrix. BioFoam contains an expansion agent which causes the material to expand its volume by a factor of four or five times and is intended for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen). The development of BioFoam has been funded by a series of grants totaling $5.5 million from the United States Department of Defense.

In September of 2010, CryoLife signed a manufacturing and distribution agreement with Starch Medical, Inc., of San Jose, California, for PerClot®, a powdered hemostat that they were marketing in Europe. PerClot is CE Marked for distribution in many European countries at this time. PerClot is not currently approved for use in the U.S..

With studies begun in 1991, Steven Goldstein, Ph.D. of our staff pushed the company into the forefront of a new approach in implantable device technology with the development of technologies that became the SynerGraft^® process. The SynerGraft decellularization process is designed to reduce cells and antigens from the implantable tissues while preserving the integrity of the tissues’ collagen matrix. SynerGraft processed pulmonary human heart valves were cleared by the FDA in May of 2008, and SynerGraft processed pulmonary cardiac patch tissue was cleared by the FDA in August of 2009. These tissues are routinely used by surgeons for a variety of cardiac reconstructive surgeries.

In May of 2011 the company completed the acquisition of Cardiogenesis corporation. Cardiogenesis, a wholly owned subsidiary of CryoLife, Inc., is a pioneer in the development and use of laser technology for transmyocardial revascularization (TMR) in patients with severe or refractory angina. It is approved by the FDA for distribution in the U.S. and is CE Marked for use in Europe. It is a Medicare approved therapy and is reimburseable. TMR is accepted as a meaningful therapy and treatment for refractive angina by the American College of Cardiology, American Heart Association and the Society of Thoracic Surgery. Cardiogenesis has a CE Mark for the use of autogenous (the patient’s own) stem cells in conjunction with TMR.

Since its early beginnings in a 2,400 sq.ft. laboratory with six employees near Hartsfield airport in Atlanta, Georgia, the company has grown into a multi-national company with 435 employees and sales in over seventy countries. The company occupies a 200,000 sq. ft. facility on a 21 acre campus in northwest Atlanta. Its wholly-owned subsidiary, CryoLife Europa Ltd., is located near Heathrow Airport outside of London, England, and serves as a European and Mediterranean distribution center for all of CryoLife’s cryopreserved tissues and implantable medical devices.