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

n 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.  CryoLife distributes PerClot®, an absorbable powder hemostat, in the European Community. CryoLife, through its subsidiary Cardiogenesis Corporation, specializes in the treatment of cardiovascular disease and devices that treat severe angina.  Its market leading FDA-approved Holmium: YAG laser system and single use fiber-optic delivery systems are used to perform a surgical procedure known as Transmyocardial Revascularization (TMR). 

Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements reflect the views of management at the time such statements are made and are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from current expectations.  These statements include those regarding our ability to enroll patients in the pilot study and the speed of such enrollment, our plans for a larger pivotal study to support a PMA application for BioFoam with the FDA, our belief that BioFoam may hold promise for surgeons around the world, our plans for a follow-on prospective, multicenter, randomized, controlled pivotal study subsequent to FDA and Department of Defense approvals, the anticipated number of eligible subjects that would enroll in the pivotal investigation, plans to use the data from the pivotal investigation to support a U.S. Premarket Approval application to allow commercialization of BioFoam in the U.S., and our estimates regarding the annual European and worldwide market opportunity for BioFoam.  These future events may not occur as and whe
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SOURCE CryoLife, Inc.
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Related medicine technology :

1. CryoLife Announces First Implant of Combination Aortic-Mitral Allograft Heart Valve at the Cleveland Clinic
2. CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)
3. CryoLife Reports Record Quarterly Revenues of $28.2 Million
4. CryoLife to Present at Upcoming Investor Conferences in New York
5. CryoLife to Present at 21st Annual Piper Jaffray Health Care Conference
6. CryoLife Provides Initial 2010 Financial Guidance
7. CryoLife Enters into Worldwide Distribution and Manufacturing Agreements with Starch Medical for Novel Hemostatic Agent
8. CryoLife Receives Japanese Regulatory Approval for BioGlue Surgical Adhesive
9. CryoLife Announces Release Date and Teleconference Call Details for 2010 Third Quarter Financial Results
10. CryoLife Begins Distribution of Blood-Clotting Agent PerClot® in Europe
11. CryoLife to Present at Lazard Capital Markets 7th Annual Healthcare Conference
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