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Corazon, Inc. Announces FDA Conditional Approval of Investigational Device Exemption for Human Clinical Trials; Company's Novel System Successfully Evaluated in Europe and South America.

Business Editors/Health/Medical Writers

MENLO PARK, Calif.--(BUSINESS WIRE)--May 5, 2003

Corazon Technologies Inc., the developer of an innovative method for demineralizing and repairing calcific aortic valves, announced today that it has received conditional IDE approval from the FDA for the clinical evaluation of its device in the United States. The Company recently conducted its first clinical evaluations of the system in Brazil and Germany.

"We are pleased with the early results from our global investigators showing post-operative improvement in aortic valve function," said Geoffrey Dillon, president and CEO of Corazon Technologies, Inc. "The IDE approval will allow us to expand our clinical investigation of decalcification as a means of addressing the chronic and debilitating effects of degenerative valve disease."

Approximately 1.2 million people over the age of 55 in the U.S. alone have some degree of aortic stenosis, and 75% have calcified aortic valve tissue. Over 60,000 patients receive an aortic prosthesis annually due to severely calcified valve tissue. Many of these patients will require re-operation within the next decade due to calcification of their bioprosthetic valve or due to failure of their mechanical valve implants.

"Our experience during the first clinical evaluation of the Corazon Aortic Valve SAVR System was very positive," said Dr. Ricardo Lima, School of Medical Science-University of Pernambuco in Recife, Brazil. "Clinically, our first patient demonstrated immediate improvement in valve function which we feel will translate to a lasting benefit."

Corazon's unique demineralization technology is the only treatment positioned to restore native valve function by repairing tissue from a diseased state. The Corazon technology may create a new treatment option for heart valve patients with mild-to-moderate disease.

"Recently we evaluated the Corazon SAVR System in two patients," said Professor Dr. Wimmer-Greinecker of J.W. Goethe Universitat in Frankfurt, Germany. "While more study will need to be done to validate the long-term benefit of our early results, we were quite pleased with the performance of the system. In each case, we were easily able to integrate the demineralization process with a complex coronary artery bypass procedure. Future treatment of degenerative valve disease could be dramatically impacted by the emergence of this new technology, especially as an adjunct to minimally invasive cardiac surgery."

Corazon Technologies, Inc. is an emerging medical device company focused on the treatment of calcific vascular disease and is developing proprietary devices that improve original valve performance by demineralizing calcific tissue. The Company is backed by a syndicate of leading medical device investors including Prospect Venture Partners, Spray Venture Fund L.P., Charter Ventures and Saratoga Ventures.
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Publication:Business Wire
Date:May 5, 2003
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