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Cardiogenesis Corporation Makes Pre-IDE Submission for PHOENIX Combination Delivery System
Date:7/30/2009

IRVINE, Calif., July 30 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (Pink Sheets: CGCP), a market leader in laser transmyocardial revascularization (TMR), today announced that it has submitted a pre-IDE (Investigational Device Exemption) to the Food and Drug Administration to initiate a feasibility trial for its PHOENIX System in patients with refractory angina. The PHOENIX Combination Delivery System combines intramyocardial laser channeling with the delivery of a biologic substance. The PHOENIX received a CE MARK in 2006 and there have been over 50 clinical cases completed to date outside of the U.S.

"The early clinical results achieved with TMR plus biologics suggest the potential of this combination therapy; to not only mitigate the debilitating effects of refractory angina, but potentially to improve cardiac function as well," said Paul McCormick, Executive Chairman. "Animal work by Dr. Patel demonstrated that the pre-treatment of myocardium with TMR enhanced cell viability and uptake when delivered with the Cardiogenesis PHOENIX combination delivery system, compared to cell therapy alone. This submission is an important step towards initiating the feasibility trial in the United States."

The company plans to evaluate the therapeutic effect of delivering Platelet Rich Plasma (PRP) in combination with TMR. PRP is derived from the patient's own circulating blood and is well documented in clinical applications for its angiogenic effect and accelerated wound healing response.

Center for Biologics Evaluation and Research (CBER) is the lead reviewing center for the PHOENIX application. The company expects to meet with CBER during the next 60 days to identify any additional information required to begin the feasibility trial.

About Cardiogenesis Corporation

Cardiogenesis is a medical device company specializing in the the
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SOURCE Cardiogenesis Corporation
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