ATLANTA and LONDON, Sept. 10 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced the first clinical implant of its BioFoam(R) Surgical Matrix, which received CE mark approval in August 2009. BioFoam was used in a liver resection procedure following tumor removal as a supplemental measure to promote hemostasis (a complex process that stops bleeding) by sealing vessels. "Despite advances in surgical technique, bleeding complications continue to be a problem in liver resection surgery and can be life-threatening," said Professor Brian Davidson, MD,
FRCS, Professor of Surgery, Department of Surgery, Royal Free Hospital in London who performed the procedure on September 9. "We are very hopeful that BioFoam will reduce the time required to achieve hemostasis during liver resection surgery and will reduce the number of complications following surgery."
CryoLife is conducting a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. The objectives of this 45-patient controlled launch, in which BioFoam is used as a surgical hemostatic adjunct in the open repair of liver parenchyma following liver resection and/or liver transplant surgery, are to (1) collect additional clinical data supporting the safety and performance of BioFoam and (2) further refine the optimal application technique. "The clinical availability of BioFoam is another milestone in the company's corporate objective of providing world-class surgical options for the control of intraoperative bleeding," said Steven G. Anderson, CryoLife president and chief executive officer. "We believe the unique adherence and expansion characteristics of this product make it useful for organ sealing and other future surgical applications. It is a wonderful complement to our existing hemostasis products, BioGlue(R) and HemoStase(TM)." In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the company's BioFoam IDE submission for liver parenchymal sealing. The feasibility phase will enroll a total of 20 subjects at two investigational sites in the U.S. Before beginning this phase, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the study from the U.S. Department of Defense. CryoLife is in the final stages of this approval process and expects to start enrollment in Q4 2009. During the European Association of Cardio-Thoracic Surgery (EACTS) annual meeting in Vienna, Austria Oct. 17-21, booth 43, CryoLife will be soliciting input from the attendees on potential future clinical applications for the use of BioFoam in cardiothoracic surgery. About BioFoam BioFoam, a protein hydrogel biomaterial developed by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It 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. BioFoam received CE mark approval for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.
