ATLANTA, Oct. 25 /PRNewswire/ — 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.(1)
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
Approva
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