IRVINE, Calif., Oct. 12 /PRNewswire/ -- Cardiogenesis Corporation (OTCQB: CGCP), a leading developer of surgical products used in the treatment of diffuse coronary artery disease, reported the enrollment of the first two patients in its PHOENIX Feasibility Study. Dr. Guillermo Reyes at La Princesa Hospital, Madrid, Spain performed the procedures utilizing the company’s proprietary PHOENIX System that combines the intramyocardial delivery of stem cells with transmyocardial revascularization (TMR).
“Myocardial stimulation via TMR has been proven to reduce angina for the majority of treated patients. The synergy of the injection of autologous stem cells may provide greater angina reduction, and improve cardiac function in patients with diffuse disease who are not candidates for surgical bypass or intervention,” commented Dr. Reyes. “Survival rates have significantly improved for persons with coronary artery disease; however as this population lives longer they can outlive the effectiveness of their prior therapy. Clinicians are faced with an expanding population of symptomatic patients with no option for conventional treatments. Stem cell therapy with the Cardiogenesis technology has great promise as a solution for this growing clinical problem.”
The two procedures were performed during an investigator meeting in Madrid, Spain on October 7-8. Leading researchers at five medical centers from France, India, Italy, Russia, and Spain will participate in the study. The company plans to begin clinical cases at those centers in the upcoming weeks.
“This is a significant milestone. We will provide the early results of this feasibility study along with the pre-clinical testing being conducted at the Stem Cell Center of the Texas Heart Institute, to support our request to begin a multi-center IDE pivotal trial in the U.S. for the PHOENIX System,” said Cardiogenesis Executive Chairman Paul McCormick. “We believe the injection of stem cells combined with the pretreatment of TMR system can prove to be an effective therapy for an expanding population of patients with no options and will provide a proprietary growth opportunity for our company.”
About Cardiogenesis Corporation
Cardiogenesis is a medical device company specializing in the treatment of cardiovascular disease and is a leader in devices that treat severe angina. Our market leading holmium:YAG laser system and single use fiber-optic delivery systems are used to perform a FDA-cleared surgical procedure known as Transmyocardial Revascularization (TMR).
For more information on Cardiogenesis and its products, please visit our website at www.cardiogenesis.com.
Safe Harbor Statement
This press release contains forward-looking statements, including, without limitation, with respect to the Company’s expectation to begin a U.S. clinical trial of the Company’s PHOENIX Combination Delivery System. Any forward-looking statements in this news release are subject to numerous risks and uncertainties, many of which are outside the Company’s control, that could cause actual results to differ materially. Factors that could affect the accuracy of these forward-looking statements include, but are not limited to: any inability by the Company to sustain profitable operations or obtain additional financing on favorable terms if and when needed; any failure to obtain required regulatory approvals; failure of the medical community to expand its acceptance of TMR procedures; possible adverse governmental rulings or regulations, including any FDA regulations or rulings; the Company’s ability to comply with international and domestic regulatory requirements; possible adverse Medicare or other third-party reimbursement policies or adverse changes in those policies; any inability by the Company to ship product on a timely basis; the Company’s ability to manage its growth; the effects of recent disruptions in global credit and equity markets and other adverse economic developments that could adversely affect the market for our products or our ability to raise needed financing; actions by our competitors; and the Company’s ability to protect its intellectual property. Other factors that could cause Cardiogenesis’ actual results to differ materially are discussed in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2009 and the Company’s other filings with the Securities and Exchange Commission. 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
