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 therapies for the treatment of chronic cardiac ischemia. The company's market leading Holmium:YAG laser system and disposable fiber-optic accessories are used to perform a FDA-cleared surgical procedure known as Transmyocardial Revascularization (TMR) to treat patients suffering from angina. Surgical products and accessories for the Cardiogenesis TMR procedure, which are marketed in the U.S. and around the world, have been shown to reduce angina and improve the quality of life in patients with coronary artery disease.
With the exception of historical information, the statements set forth above include forward-looking statements. Any forward-looking statements in this news release related to the possible effectiveness of the company's PHOENIX delivery system or other technologies and the planned clinical trials, are based on current expectations and beliefs and are subject to numerous risks and uncertainties, which are discussed in the "Risk Factors" section of the company's Annual Report on Form 10-K for the year ended December 31, 2008 and the company's other recent SEC filings. The company disclaims any obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.
|SOURCE Cardiogenesis Corporation|
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