Cardiogenesis Submits IDE to Initiate a Clinical Trial for Its PHOENIX Combination Delivery System
IRVINE, Calif., Jan. 4 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (Pink Sheets: CGCP), today announced that it has submitted an IDE (Investigational Device Exemption) to the Food and Drug Administration to initiate a safety and feasibility trial for its PHOENIX System in patients with refractory angina. The PHOENIX handpiece is the first device specifically designed to allow physician-directed tissue stimulation and injections of biologic or pharmacologic agents to pre-determined areas of myocardium.
Dr. Guillermo Reyes, Department of Cardiovascular Surgery, Hospital Universitario La Princesa, Madrid, Spain commented on his preliminary clinical experience with the device. "To date I have successfully treated eighteen patients utilizing the PHOENIX with bone marrow derived stem cells. These were patients with severe angina and not candidates for coronary bypass or percutaneous intervention. At follow up, all of the patients improved by at least two classes of angina, and one-half were angina free. Based on the published literature and my own experience, laser channeling has proven to be a valuable clinical option. This preliminary study suggests the addition of stem cells is synergistic and this combination therapy offers the potential to improve clinical results and expand the utility of this approach."
"This is a significant milestone for the company," said Paul McCormick, Executive Chairman. "While there has been progress in the research of cell therapy in the treatment of advanced heart disease, the potential has yet to be fully realized in the clinical setting. The excitement about our combination therapy is based on the promising initial clinical results achieved by Dr. Reyes and others. These results build upon the in vivo research demonstrating that PHOENIX increased stem cell survival in targeted heart muscle when compared to direct injection alone. Our focus is on proprietary delivery systems that will help realize the therapeutic promise of biologics and stem cells in the treatment of ischemic heart disease."
The PHOENIX includes an integral CrystalFlex fiberoptic component consisting of thirty-seven 100 µm diameter fibers, identical to the fiberoptic component currently in use in the FDA approved Sologrip® III and PEARL™ 5.0 handpieces. The handpiece has been modified to include three 26 gauge needles positioned around the fiberoptic fibers, which allow precise delivery of biologic/pharmacologic fluids into the tissue surrounding the channels created by the fiberoptic.
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.
For more information on the company and its products, please visit the Cardiogenesis company website at http://www.cardiogenesis.com or the direct to patient website at http://www.heartofnewlife.com.
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