(By Balaseshan) Cryolife Inc. (NYSE: CRY) said 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.
CryoLife estimates the annual European market opportunity for BioFoam, including for cardiovascular and parenchymal tissues, BioGlue and PerClot is more than $100 million.
"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," said Steven G. Anderson, chief executive of CryoLife.
BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent that generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and forms pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis.
BioFoam is easily applied and can be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future reoperations in liver resections. BioFoam is based on the same protein hydrogel technology platform from which BioGlue Surgical Adhesive was developed.
The company preserves and distributes human tissues for transplantation and develops, manufactures, and commercializes medical devices for cardiac and vascular applications. It operates in two segments: preservation services and medical devices segment.
CRY is trading up 0.58% at $6.03 on Wednesday. The stock has been trading between $4.08 and $7.27 for the past 52 weeks.