Founded in 1984, CryoLife was the first biomedical company to specialize in the low temperature preservation of human heart valves used for complex cardiac reconstruction primarily in children born with heart defects. Since those initial efforts, CryoLife’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. CryoLife’s proprietary processes for preserving these cardiovascular tissues have dramatically improved and enhanced the lives of one hundred thousand patients primarily in North America.
With studies beginning in 1991, Steven Goldstein, Ph.D., CryoLife’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. 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 1 million 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. CryoLife recently received a CE Mark application for the use of BioFoam in cardiac and vascular reconstruction procedures. 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. CryoLife has received a conditional approval for an Investigational Device Exemption to begin clinical testing of the product in the United States, subject to the Company making certain revisions and refiling the IDE. Manufacturing operations for PerClot began in the third quarter of 2013 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. International sales of PerClot increased 30% in the first nine months of 2013 over the first nine months of 2012, to $2.7 million.
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. Revascularization technologies in the first nine months of 2013 were $6.8 million, an 11% increase over the first nine months of 2012.
In January 2016, CryoLife completed Acquisition of On-X Life Technologies Holdings, Inc, the leading manufacturer of artificial heart valve replacement and repair products. This acquisition is expected to provide CryoLife access to the $220 million mechanical valve market with a highly advanced portfolio of products. On-X valves have been implanted in over 200,000 patients, and On-X has achieved a13% revenue CAGR over the past four years with modest sales and marketing support. The On-X aortic valve is the only mechanical valve to receive FDA labeling requiring an INR (international normalized ratio) level of only 1.5-2.0, providing a distinct competitive advantage.
Since its early beginnings with six employees in a 2,400 sq. ft. laboratory near Hartsfield airport in Atlanta, Georgia, CryoLife has grown into a multi-national company with over 500 employees and sales representation in over 75 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. In February 2014 a new sales and marketing center will be opened in Singapore and will support all of the Company’s business in the Pacific Rim countries; Japan, China, South East Asia, Australia, Malaysia and Indonesia.
