CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has begun European distribution of PerClot®, a novel polysaccharide hemostatic agent used to control bleeding during surgical procedures or following traumatic injuries.
"PerClot is an exciting technology platform that has seen success in Europe already, and we are pleased to begin offering this product in France," stated Steven G. Anderson, CryoLife president and chief executive officer. "Our international and largely unrestricted distribution agreement allows us to address a very broad range of medical specialties in the growing hemostatic agent market. We look forward to expanding distribution within the European Union and many other markets around the world in the coming months."
The European hemostatic market is estimated to be $279 million in 2010 growing to approximately $430 million in 2014.
On September 28, 2010, CryoLife entered into a worldwide distribution agreement and a manufacturing agreement with Starch Medical Inc. (SMI) of San Jose, California for PerClot, a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets. PerClot is indicated for use in surgical procedures, including cardiac, vascular, orthopedic, spinal, neurological, gynecological, ENT and trauma surgery as an adjunct hemostat when control of bleeding from capillary, venous, or arteriolar vessels by pressure, ligature, and other conventional means is either ineffective or impractical.
CryoLife plans to file an Investigational Device Exemption (IDE) with the United States Food and Drug Administration (FDA) to begin clinical trials for the purpose of obtaining Pre-Market Approval (PMA) to distribute PerClot in the U.S.
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