FOOTHILL RANCH, Calif., March 7 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures, announced today the publication of an Expert Review of Medical Devices focused on the Company’s Holmium:YAG TMR system in the March edition of Future Drugs.
Future Drugs is a scientific publication based in the UK that provides healthcare practitioners and research professionals with objective cutting-edge information on exciting emerging trends in healthcare and advances in the major therapeutic areas through the Expert Review series.
Chairman and CEO, Michael J. Quinn commented on this prominent publication. “It is noteworthy to see recognition of the increasing clinical importance of the TMR therapy in a cutting edge scientific journal. This is a reflection of the substantial published body of evidence supporting the clinical significance of our Holmium:YAG TMR system, and our efforts in advancing the technology to improve patient outcomes. We are now completing the IDE feasibility trials with our minimally invasive PEARL surgical delivery systems, and have initiated our preliminary safety and feasibility trial with our advanced PHOENIX Revascularization Delivery System for the precise targeted delivery of biologic or pharmacologic materials to the Holmium:YAG thermoacoustic stimulated tissue zone surrounding our TMR channels.”
The Expert Review article “Holmium:YAG laser system for transmyocardial revascularization” is authored by Keith B. Allen, MD of the Heart Center of Indiana. In his discussion of mechanism of action, the author highlights the more than 20 peer reviewed works published from researchers at Duke University Medical Center. He states, “Angiogenesis is the most likely mechanism of action responsible for clinical improvement following TMR, and research should be continued to find ways to augment this process.”
Mr. Quinn stated, “We are taking the important next steps with TMR to increase its physiologic and clinical impact. Reducing the surgical injury required in delivering this powerful therapy with our minimally invasive PEARL Robotic and Thoracoscopic delivery systems is an important platform improvement. We are now leveraging our understanding of the thermoacoustic stimulated tissue zone created by our Holmium:YAG fiberoptic delivery system for the delivery of potent therapeutic agents to generate an even greater response. The PHOENIX combination delivery system provides the precise and targeted delivery of biologic or pharmacologic therapeutic agents directly into and around the thermoacoustic stimulated tissue zone.”
In the Future Drugs article, the author cited the improved Kaplan Meier survival at 5 years achieved with the Cardiogenesis Holmium:YAG system (Annals of Thoracic Surgery. 78, 458-65 (2004)). Dr. Allen stated in his remarks, “Considering the increased operative and long term cardiac risks predicted by incomplete revascularization and the documented operative and long term benefits associated with adjunctive TMR in randomized patients with diffuse CAD, increased utilization of this therapy is warranted. In parallel, it is imperative that research continues into identifying growth factor, therapeutic or stem cell-based materials, which when coadministered may enhance these positive outcomes.”
Mr. Quinn concluded, “We strongly agree with Dr. Allen’s conclusion that the published results of TMR as a primary and secondary therapy supports increased utilization of TMR in the treatment of diffuse coronary artery disease. We are also focused on advancing the technology to make available our minimally invasive PEARL delivery systems and the PHOENIX combination delivery system to optimize patient outcomes.”
About Cardiogenesis Corporation
Cardiogenesis is a medical device Company specializing in the treatment of cardiovascular disease and is a leader in devices that stimulate cardiac angiogenesis. 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. Surgical products and accessories for the Company’s minimally invasive Percutaneous Myocardial Channeling (PMC) procedure are currently being marketed in Europe and other international markets.
For more information on the Company and its products, please visit the Cardiogenesis company web site at www.cardiogenesis.com or the patient and physician website at www.heartofnewlife.com. Heartofnewlife.com is a resource for patients and physicians which provides medical information on TMR.
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; 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, 2004, the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2005, 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.
Cardiogenesis Corporation
CONTACT: Michael J. Quinn, Chairman and CEO, +1-714-649-5050, or ChristineG. Ocampo, Sr VP, CFO, +1-714-649-5066, both of Cardiogenesis Corporation
