|A Brief History & Profile|
Founded in 1984, CryoLife was the first biomedical company to specialize in the 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 expanded to include cardiac patches, saphenous veins, femoral arteries and veins as well as aorto-illiac vessels for use in central and peripheral vascular reconstruction. The company’s proprietary processes for preserving these cardiovascular tissues have dramatically improved and enhanced the lives of countless patients primarily in North America.
With studies begun in 1991, Steven Goldstein, Ph.D., the company’s Senior Director of Tissue Technologies, pushed the company into the forefront of a new approach in implantable tissue-based devices with the development of a decellularization technology that became known as the SynerGraft® process. The SynerGraft process is designed to remove cells and antigens from the implantable tissues while preserving the integrity of the tissues’ collagen matrix. SynerGraft processed human pulmonary 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 2009. In early 2012, the company applied to the FDA for a humanitarian device exemption (HDE) for SynerGraft processed human aortic heart valves. SynerGraft processed cardiac patches and valves are used by surgeons for complex cardiac reconstruction and valve replacement procedures.
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 clinical 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. In early 2011, BioGlue was approved in Japan, the world’s second largest surgical adhesive market after the U.S. Since its U.S. and international approvals, it is estimated that BioGlue has been used in over 750,000 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 that 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 such as liver and spleen. The company is planning to file a CE Mark application for the use of BioFoam in cardiac and vascular reconstruction procedures in the third quarter of 2012. BioFoam’s development was funded with grants from the Department of Defense for approximately $5.5 million.
In September of 2010, CryoLife signed an exclusive worldwide manufacturing and distribution agreement with Starch Medical of San Jose, California, for a powdered hemostatic agent, PerClot®. PerClot is CE Marked and is available in certain international markets at this time. The company has applied to the FDA for an Investigational Device Exemption to begin clinical testing of the product in the United States. Manufacturing operations for PerClot are scheduled to begin in the fourth quarter of 2012 at our corporate headquarters facility. This new manufacturing facility will initially be focused on supplying PerClot for the United States human clinical trials and, pending regulatory approvals, to support the Canadian and Brazilian markets.
In May of 2011, the company completed the acquisition of Cardiogenesis Corporation. Cardiogenesis is a pioneer in the development and use of laser technology for transmyocardial revascularization (TMR) in patients with severe angina. The Cardiogenesis system is approved by the FDA and is CE Marked in Europe. TMR is accepted as a meaningful therapy and treatment for refractive angina by the American College of Cardiology, The American Heart Association, and the Society of Thoracic Surgeons.
In May of 2012, the company acquired Hemosphere, Inc., of Eden Prairie, Minnesota, a manufacturer of the HeRO® Graft for access-challenged and catheter dependent hemodialysis patients. With over 5,000 human implants it has been shown to have 69% fewer infections than dialysis catheters. The HeRO Graft complements our preserved human femoral veins and arteries that are oftentimes used as dialysis access grafts in patients with an infected AV graft or patients where an autogenous fistula is not feasible. With the acquisition of the HeRO Graft we can now address a wider range of renal dialysis patient populations.
Since its early beginnings with six employees in a 2,400 sq. ft. laboratory near Hartsfield airport in Atlanta, Georgia, the company has grown into a multi-national company with over 450 employees and sales representation in over 70 countries. The company now occupies a 200,000 sq. ft. corporate headquarters 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 CryoLife’s implantable medical devices.