IRVINE, Calif., June 4 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation the market leader in laser transmyocardial revascularization (TMR) for the treatment of chronic cardiac ischemia, announces that Dr. Naresh Trehan of New Delhi will be presenting his clinical results of combining laser TMR and stem cells to treat regions of myocardium that could not be revascularized by conventional methods. Eight patients treated with the PHOENIX System completed 1 year follow up:
The PHOENIX combination delivery system is CE Mark approved and has been used in over 50 procedures at cardiac centers outside the U.S. It is not currently FDA approved. The abstract "One Year Follow up of Combined Autologous Bone Marrow Derived Progenitor Cell Therapy and Transmyocardial Laser Revascularization for Diffuse Nongraftable Coronary Artery Disease" can be located at: http://www.ismics.org/abstracts/2009/10.html.
"These results add to the growing body of evidence that TMR has a positive impact on the intramyocardial delivery of biologics, such as stem cells. The PHOENIX System is designed to create transmural laser channels and with its three integrated injector needles, deliver the biologic into the surrounding tissue," said Richard Lanigan, President of Cardiogenesis. "These results, along with a paper recently published in the European Journal of Cardiothoracic Surgery, "Bone Marrow Laser Revascularisation for Treating Refractory Angina Due to Diffuse Coronary Heart Disease", reinforce the company's regulatory strategy of submitting an IDE for its PHOENIX System in the upcoming months."
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 effect of such system or technology on the company's sales, profitability, the adoption of its technology and products and FDA clearances are based on current expectations and beliefs and 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 or PMC 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; adverse economic developments that could adversely affect the market for our products or our ability to raise needed financing; actions by our competitors; restrictions contained in our convertible debt obligations requiring the issuance of shares rather than repayment in cash; 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-KSB 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.
CONTACT: William R. Abbott, Senior Vice President and Chief Financial
Officer of Cardiogenesis Corporation, +1-949-420-1800
Web site: http://www.cardiogenesis.com/