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

r cardiac tissue repair applications," continued Dr. Boyd. "As with pericardial closure, intracardiac repair using the CorMatrix ECM restores the natural anatomy of the heart. We are pleased that this additional approval will allow us to use the material beyond the pericardium."

Following implantation by a surgeon, CorMatrix ECM Technology products act as a scaffold into which the patient's own cells migrate and integrate, stimulating the body's innate wound-healing mechanisms to repair tissue at the site of implantation. As the patient's cells populate the matrix they lay down their own collagen, which matures over time to form a functional tissue repair. The implanted ECM material is gradually replaced and resorbed by the body as the patient's tissue is remodeled.

Available commercially since 2006 for the reconstruction and repair of the pericardium during cardiac surgery, the CorMatrix ECM for Pericardial Closure has been implanted during more than 4,000 cardiac procedures at more than 160 U.S. hospitals.

The company also announced it received CE Mark approval in the first quarter for the CorMatrix ECM for Pericardial Closure and anticipates launching this product in Europe and other international markets later this year.

"We have received a tremendous response from the clinical community for our first product for pericardial closure and believe that the addition of our cardiac tissue repair product will provide an important advancement for cardiac surgeons and their patients," said Beecher Lewis, President and COO of CorMatrix. "Because our ECM Technology supports native tissue repair, it represents a significant advancement over currently available materials."

About Extracellular Matrix Biomaterial

The unique properties of extracellular matrix biomaterials were discovered at Purdue University. The decellularized matrix material serves as a scaffold to allow adjacent tissues to deliver cells and nutrients to the matrix,
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SOURCE CorMatrix Cardiovascular, Inc.
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