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CorMatrix(R) Announces FDA 510(k) for Novel Biomaterial Implant for Intracardiac Repair
Date:5/8/2008

which then differentiate into tissue-specific cells. The ECM material is gradually replaced, as the patient's own body reinforces and rebuilds the weakened site. During the repair the matrix is rapidly degraded and resorbed, leaving remodeled functional tissue where scar tissue or injured tissue would normally be expected.

The use of extracellular matrix materials in non-cardiovascular applications has established a significant foothold in soft tissue repair, wound management and orthopedic applications. The safety of extracellular matrices has been well established in a number of different clinical applications. The extracellular matrix has been studied extensively, with more than 500 published papers. Since 1999, an estimated 500,000 patients worldwide have received an extracellular matrix implant.

About CorMatrix ECM Technology(TM)

CorMatrix Cardiovascular holds an exclusive license from Purdue University to research, develop, manufacture and market naturally occurring extracellular matrix products for cardiovascular applications. CorMatrix is currently conducting a number of preclinical studies utilizing the ECM Technology for a variety of cardiovascular applications. The company has U.S. and European clearance to market the CorMatrix ECM Technology(TM) as an implant for pericardial closure and clearance in the U.S. for cardiac tissue repair. CorMatrix ECM Technology is used at more than 160 hospitals across the U.S. and has been implanted during more than 4,000 cardiac procedures.

The CorMatrix ECM Technology platform utilizes a naturally occurring extracellular matrix biomaterial that is harvested from porcine small intestine submucosa. To transform the raw extracellular matrix material into the CorMatrix ECM Technology, the matrix is processed to remove cells, effectively eliminating any immune rejection.

About CorMatrix Cardiovascular, Inc.

CorMatrix Cardiovascular, a privately held company based in Atlanta, Georgia,
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SOURCE CorMatrix Cardiovascular, Inc.
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