FOOTHILL RANCH, Calif., April 27 /PRNewswire-FirstCall/ -- Cardiogenesis Corporation , the market leader in surgical products and accessories used in angina-relieving Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC(TM)) procedures, announced today that leading investigators with growing experience utilizing advanced minimally invasive TMR surgical tools in the PEARL(TM) (Port Enabled Angina Relief with Laser) Trial, have begun presenting their findings at prominent scientific meetings and in clinical publications. The PEARL Trial is a nationwide investigation of new devices enabling the application of transmyocardial revascularization (TMR) through minimally invasive port access. These port access procedures allow surgeons to treat patients who suffer from chronic severe angina using novel robotic and thoracoscopic techniques.
On April 25, 2006, Louis A. Brunsting, III, M.D., Centennial Medical Center in Nashville, Tennessee, presented his findings on the Cardiogenesis PEARL 5.0 device for TMR in a session entitled “Totally Endoscopic Robotic Assisted TMR” at the ACTS (Advanced Cardiac Techniques in Surgery) meeting in New York. Dr. Brunsting’s experience leads the nation in the use of the Intuitive Surgical da Vinci(R) Surgical System to assist with the TMR procedure. According to Dr. Brunsting, “Cardiogenesis is the only company enabling delivery of TMR through small ports in a closed-chest, robotically assisted technique. Our experience has been that these techniques can provide patients the substantial angina relief of TMR while significantly speeding patient recovery times.”
Gary S. Allen, M.D., Osceola Regional Medical Center, Orlando, Florida is currently presenting his techniques and preliminary findings from the PEARL Trial on CTSNet (www.ctsnet.org) under the heading of Expert Techniques in Adult Cardiac Surgery. Dr. Allen has performed numerous procedures utilizing the PEARL thoracoscopic device and his findings are promising. Dr. Allen notes, “The Cardiogenesis PEARL thoracoscopic device allows physicians to perform a minimally invasive TMR procedure in a less technically demanding operation and allows patients to resume normal activity in less time than more traditional approaches.” Dr. Allen has accepted an invitation to present his findings at the upcoming International Society for Minimally Invasive Cardiac Surgery (ISMICS) meeting to be held on June 9, 2006 in San Francisco.
“We are very encouraged by the clinical outcomes to date with the PEARL platform and look forward to adding these important devices to our market basket as we continue to strengthen our product offering to the cardiothoracic surgeons,” said Michael J. Quinn, Cardiogenesis chairman and CEO.
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 of Cardiogenesis Corporation,+1-714-649-5050
