Tuesday, August 4, 2009

CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology

ATLANTA, Aug. 4 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and cardiovascular tissue processing company, today announced it has received CE mark approval for its BioFoam((R)) Surgical Matrix (BioFoam). The CE mark allows immediate, unrestricted commercial distribution of BioFoam in the European Community 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. BioFoam is the second product from the Company's protein hydrogel technology platform to receive a CE mark. CryoLife plans a controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy to support its initial marketing efforts. Based on the number of liver and spleen procedures performed annually in the European Community, CryoLife estimates the annual European market opportunity for BioFoam to be approximately $30 million and more than $100 million on a worldwide basis. "We are excited about securing our first approval for the use of BioFoam in organ resection surgery and look forward to continuing our development efforts to bring BioFoam into the U.S. market," said Steven G. Anderson, CryoLife president and chief executive officer. "Over the past four fiscal years, the U.S. Department of Defense has allocated approximately $5.4 million to CryoLife for the development of products containing a protein hydrogel, which is the primary component of BioFoam." 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.

About BioFoam

BioFoam® Surgical Sealant (BioFoam) is a two-component surgical sealant composed of purified bovine serum albumin (BSA) solution with sodium bicarbonate and glutaraldehyde solution with acetic acid. The two components of BioFoam are contained in a dual chambered syringe and, at the point of delivery, are mixed in a specially designed applicator tip. Upon delivery of the BioFoam, the sodium bicarbonate and acetic acid react with each other causing the material to foam to an approximate 5-fold expansion. The aldehyde groups of the glutaraldehyde react with the amine groups of the BSA and/or tissue surface proteins and generate chemical cross-links (covalent bonds). These chemicals cross-link together to form a mechanical seal at the site of application. The aldehyde groups are in slight molar excess over the amine groups, ensuring the cross-linking of the BSA molecules to each other and to the tissue at the application site. Polymerization of the BioFoam begins immediately upon application, sets up within 15-20 seconds and reaching full bonding strength within 2 minutes.

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