Cardiogenesis Comments on the STAR-Heart Study Presented at European Society of Cardiology (ESC) 2010 Congress
IRVINE, Calif., Sept. 2 /PRNewswire/ — Cardiogenesis Corporation (OTCQB: CGCP), released comments today regarding the STAR-heart study.
The STAR-heart study, which was presented at the European Society of Cardiology 2010 Congress in August 2010, reported that the intracoronary injection of autologous stem cells derived from bone marrow is associated with improved hemodynamics and long term survival in the treatment of chronic heart failure. The study involved 391 patients with chronic heart failure due to ischemic cardiomyopathy. Of these patients, 191 accepted the stem-cell treatment while the other 200, who did not agree to the intervention, acted as controls.
Commenting on these results, Paul McCormick Executive Chairman for Cardiogenesis said, “The positive results of the STAR-heart study reinforce our plan to initiate in the near future clinical studies in which autologous bone marrow cells will be used in conjunction with transmyocardial revascularization (TMR). Although our clinical studies testing delivery of stem cells with the PHOENIXÃ‚® Combination Delivery System will target different patient populations than the STAR study, the STAR study demonstrated the clinical benefit that can be derived from autologous bone marrow cells in patients with heart disease. The use of autologous bone marrow cells is akin to harnessing the combination of biologics that is naturally produced by the body as part of its regenerative process. Also relevant to our planned studies was the commentary by the STAR study investigators that pre-conditioning of the target myocardium was a key factor in the success of their implanted stem cells. Pre-conditioning in the STAR trial was accomplished by an ischemia-producing stimulus caused by balloon dilatation during the stem cell infusion, which seems to be important for creating an environment for the stem cells to home into the cardiac tissue and improve cell retention. In our clinical studies, PHOENIX will utilize its TMR System to create an environment to maximize cell retention by first treating the target myocardium with TMR, followed by cell injection. Our clinical studies follow on animal (pig) studies that demonstrated increased early cell survival in infarcted tissue when TMR was used as a pre-treatment to stem cell injection. We are optimistic that the combination of TMR plus concentrated bone marrow cells will have a synergistic effect in reducing angina in humans.”
The company recently announced its plan to begin enrollment in a feasibility trial for the PHOENIXÃ‚® Combination Delivery System. The results of that ex-US study will be used in support of its FDA submission to begin a pivotal trial in the US.
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 website at http://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(TM) 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