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CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
Date:10/27/2009

ATLANTA, Oct. 27 /PRNewswire-FirstCall/ -- CryoLife, Inc., (NYSE: CRY), an implantable biological medical device and cardiovascular tissue processing company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company's Investigational Device Exemption (IDE) to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. BioFoam will be used to help seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical.

The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent. The feasibility investigation will be conducted at two investigational sites and will enroll 20 eligible subjects with 10 subjects in each treatment group. CryoLife now will seek approval from the U.S. Department of Defense (DoD), which will be the final step necessary to begin this trial.

"Following our July 2009 CE Mark approval to distribute BioFoam in the EU, we now have approval to begin a clinical trial, a critical step forward in the process to gain FDA approval of BioFoam in the U.S.," said Steven G. Anderson, CryoLife president and chief executive officer. He added, "We believe that BioFoam may hold tremendous promise for surgeons around the world and are excited by the early data published thus far."

CryoLife is currently conducting a 60-patient controlled clinical launch of BioFoam at up to six centers in the United Kingdom, Germany, France and Italy. Based on the number of liver and spleen procedures performed annua
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SOURCE CryoLife, Inc.
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