Sep 30 2010
CryoLife, Inc. (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, announced today that it has entered into a worldwide distribution agreement and a manufacturing agreement with Starch Medical Inc. (SMI) of San Jose, California for PerClot®, a novel polysaccharide hemostatic agent used in surgery.
PerClot is a unique, absorbable powder hemostat that has CE Mark designation allowing commercial distribution into the European Community and other markets. It 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.
"PerClot is an exciting technology platform that has already seen significant success in Europe. Its unique formulation allows for full and rapid absorption, while showing excellent hemostatic capabilities. We are very pleased to have secured the rights to this second generation hemostatic agent and its laparoscopic delivery devices via an agreement that will allow us to serve a broader range of medical specialties and leverage the continued opportunities in the large and growing hemostatic agent market," said Steven G. Anderson, president and chief executive officer.
The U.S. hemostatic market is estimated to be $732 million in 2010 growing to approximately $1.1 billion in 2014, while the European market is estimated to be $279 million in 2010 growing to approximately $430 million in 2014.(1)
CryoLife intends to distribute both PerClot and HemoStase® until CryoLife can no longer sell HemoStase as a result of Medafor's termination of the parties' distribution agreement for HemoStase. Alternatively, CryoLife believes that in accordance with the terms of the agreement, at its sole discretion, CryoLife can return its inventory of HemoStase to Medafor for reimbursement. CryoLife anticipates that it will commence distribution of PerClot in several international markets in the fourth quarter of 2010 and will obtain U.S. FDA approval by the end of 2013.
"We were restricted by Medafor's continued attempts to terminate our agreement, including interruptions in product shipments. In addition, our agreement with Medafor limited our ability to sell HemoStase in all surgical specialties. Our international and largely unrestricted distribution agreement with SMI for PerClot addresses these issues and allows us to remain active in this important market," said Mr. Anderson.
Source: http://www.cryolife.com.