AUGUST 5, 2009--Cardiogenesis Corp. (Irvine, CA; Pink Sheets: CGCP), developer of laser transmyocardial revascularization (TMR) systems, says it has submitted a pre-IDE (Investigational Device Exemption) to the US Food and Drug Administration (FDA) to initiate a feasibility trial for its Phoenix System in patients with the heart condition refractory angina. The Phoenix Combination Delivery System combines intramyocardial laser channeling with the delivery of a biologic substance. It received a CE mark in 2006 and more than 50 clinical cases have been completed outside 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.
The FDA's Center for Biologics Evaluation and Research (CBER) is the lead reviewing center for the Phoenix application. The company expects to meet with CBER before the end of September to identify any additional information required to begin the feasibility trial.
Cardiogenesis specializes in therapies for the treatment of chronic cardiac ischemia. The company's Holmium:YAG laser system and disposable fiber-optic accessories are used to perform TMP, which is an FDA-cleared surgical procedure designed 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.