Cardiogenesis Advanced Delivery System Gains European Approval
Cardiogenesis Receives CE Mark Approval to Market PHOENIX Combination Delivery System
IRVINE, Calif., Oct. 10 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation (OTC: CGCP), a leading developer of surgical products and accessories used in angina-relieving procedures, announced today that the company has received CE Mark approval for marketing its advanced combination delivery system.
The device, called the PHOENIX Combination Delivery System, provides for the delivery of the company's proprietary Ho: YAG laser energy used for transmyocardial revascularization along with precise delivery of a biologic or pharmacologic therapeutic material to areas of the myocardium that cannot be bypassed during cardiac surgery. It has been estimated that up to 6% of patients receiving a diagnostic catheterization (over 120,000 patients worldwide) with advanced coronary artery disease are not candidates for stenting or bypass surgery, and up to 25% of the 800,000 bypass procedures performed worldwide annually have areas of the heart muscle that are poor targets for bypass due to severe coronary artery disease.
Regarding the European approval to market the PHOENIX TMR plus biologic delivery system, Chairman and CEO Joseph R. Kletzel, II stated, 'This initial approval will support the controlled launch of the PHOENIX system in Europe and other targeted international markets with clinicians who are providing advanced biologic and cell therapies to patients suffering from advanced heart disease. We intend to work closely with the initial centers to collect and publish data of interest about this advanced technology to clinicians, providers and patients in need.'
The company has previously reported the completion of the first clinical cases with the PHOENIX TMR plus biologic delivery system in Beijing by Dr. Feng Wan. In the initial cases, Dr. Wan used PHOENIX to deliver Ho: YAG laser energy in combination with a concentration of autologous bone marrow stem cells to areas of the heart that could not be bypassed.
Regarding the progress of the PHOENIX development plan Kletzel explained, 'We are working closely with researchers and the early clinical adopters of the PHOENIX technology to advance the clinical application in support of a full commercial launch. We are conducting basic and translational research in support of the advanced PHOENIX Combination Delivery System to assist clinicians in optimizing their therapeutic strategy and clinical outcomes. We will utilize the initial clinical information, along with the research results achieved with PHOENIX in determining the appropriate regulatory, reimbursement and commercial strategies in the U.S. going forward.'
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 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-K for the year ended December 31, 2005, the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, 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
Source: PR Newswire (October 10, 2006 - 7:50 AM EST)
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