BioFoam has received CE Mark certification, which permits its sale within the European Economic Area (EEA). BioFoam’s CE Mark certification is for the following indication:

“…for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or conventional methods is ineffective or impractical.”

The US Food and Drug Administration (FDA) has granted CryoLife an Investigational Device Exemption (IDE) which permits BioFoam Surgical Matrix to be used in a clinical study in the United States of America to determine its safety and effectiveness in sealing liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.

CryoLife Awarded U. S. Patent for BioFoam