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ATLANTA, Dec. 5, 2012 /PRNewswire/ -- CryoLife, Inc. (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced today that it has received regulatory approval in Europe to market its BioFoam® Surgical Matrix as an adjunct to hemostasis in cardiovascular surgery when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BioFoam has previously been approved in Europe as an adjunct to hemostasis in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.
"We are pleased to receive an expanded indication for BioFoam in Europe," said Steven G. Anderson, CryoLife president and chief executive officer. "We have been encouraged by the early clinical experience in Europe with liver and spleen procedures and believe the product is well suited to provide rapid hemostasis in cardiovascular surgeries. This expanded indication aligns with our BioGlue and PerClot market opportunity in Europe, giving us another sales driver and product to add to our selling efforts for our core cardiovascular surgeon customers. BioFoam is an important extension to our portfolio, providing a solution for cardiac surgical needs, as a combination sealant/hemostat."
CryoLife estimates the annual European market opportunity for BioFoam, including for cardiovascular and parenchymal tissues, BioGlue and PerClot is more than $100 million[1].
[1] Based on Millennium Research Group (European Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2012; and European Surgical Procedure Volumes 2010) and Company estimates.
About BioFoam
BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansi
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