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CryoLife Initiates Enrollment in U.S. Clinical Trial for BioFoam®
Date:10/24/2011

pated that the pivotal investigation would enroll a total of 164 eligible subjects, 82 subjects in each treatment group across a maximum of 10 investigational sites. This data would then be used to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S.

The primary objective of the pivotal investigation will be to demonstrate a decrease in the time to achieve intraoperative hemostasis (a complex process that causes bleeding to stop) following open liver resection surgery in subjects receiving an application of BioFoam compared to a control group (standard topical hemostatic agent).  The secondary objectives of this investigation will be to compare time to hemostasis and the achievement of immediate hemostasis between the BioFoam group and control group to demonstrate that BioFoam is at least equivalent in performance.  

In Europe, CryoLife has completed a 55-patient prospective, multicenter, single-arm study of BioFoam at three centers in the United Kingdom, Germany, and France. The results from this study were presented at the Association of Surgeons of Great Britain and Ireland (ASGBI) Congress in May 2011.  The efficacy results show that the time to obtain hemostasis after an application of BioFoam compares favorably to results reported for related products.  Analysis of the safety endpoints defined for this study and the collection of adverse events were also consistent with data reported within historical literature.  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 USD and more than $100 million USD worldwide.

About BioFoam

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 an
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SOURCE CryoLife, Inc.
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