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CryoLife Receives CE Mark Approval for BioFoam(R) Hemostatic Technology
Date:8/4/2009

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, a protein hydrogel biomaterial under development 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 could potentially 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((R)) Surgical Adhesive was developed. BioGlue is approved by the U.S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.

About CryoLife, Inc.

Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve((R)) SG pulmonary heart valve, processed using CryoLife's proprietary SynerGraft((R)) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed, or malfunctioning native pulmonary valves. The Company's BioGlue((R)) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. BIOGLUE Aes
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SOURCE CryoLife, Inc.
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Related medicine news :

1. CryoLife Reports Record Quarterly Revenues of $28.2 Million
2. CryoLife Announces Release Date and Teleconference Call Details for 2009 Second Quarter Financial Results
3. Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology
4. CryoLife Announces Release Date and Teleconference Call Details for First Quarter 2008 Financial Results
5. William F. Northrup, III, M.D. Joins CryoLife as Vice President of Medical Relations and Education
6. Cryolife Victim Responds to Untrue Assertions of Cryolife
7. CryoLife Announces Additions to Management Team
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