FOOTHILL RANCH, Calif., Feb. 9 /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 first clinical surgical cardiac revascularization procedure completed on January 25, 2006 by Dr. Wan Feng, Chairman of the Department of Cardiac Surgery at The People's Hospital of Beijing University with its PHOENIX Revascularization Delivery System for precise delivery of stem cells in conjunction with Holmium: YAG TMR.
Chairman and CEO, Michael J. Quinn commented, "There is exciting clinical potential for precise biologic delivery to the Holmium:YAG thermoacoustic stimulated tissue zone surrounding the TMR channels at the time of cardiac surgery. The PHOENIX Delivery System is a priority development program for the Company, which we expect to implement with both our surgical and percutaneous Holmium:YAG laser myocardial revascularization platforms. We are focused on verifying the surgical safety and feasibility with Dr. Wan and other targeted centers around the world as we understand more about the application stem cells and other biologics to increase and optimize the physiologic benefits of our therapy."
Mr. Quinn continued, "We are encouraged by the positive feedback received from Dr. Wan and his team regarding the first clinical case with the PHOENIX Revascularization Delivery System. His feedback confirms that we are on the right track in delivering the correct advanced tools to surgeons striving to provide the optimal combination of therapies during a surgical procedure to patients suffering from severe cardiovascular disease. This advanced tool combines the precise delivery of stem cells or other biologic and pharmacologic therapy to the thermoacoustic stimulated tissue zone surrounding the Holmium:YAG TMR channels."
The procedure combined the off-pump coronary artery bypass grafting, with implantation of autologous stem cells in conjunction with transmyocardial revascularization (TMR) using the PHOENIX Revascularization System. The patient is a 77 year old female suffering from chest pain related to an acute myocardial infarction. Angiography confirmed severe three vessel disease. In preparation for the procedure, 5 ml of stem cells were derived from the patient's bone marrow. Following the off pump heart bypass through a median sternotomy, the TMR channeling and implantation of stem cells in and around the channels was performed using the Cardiogenesis PHOENIX Revascularization System (the TMR Holmium:YAG laser and PHOENIX Revascularization Delivery System) in all ischemic regions and the infarct zone.
Dr. Wan stated, "We utilize advanced surgical techniques to provide enduring patient benefits while minimizing the risk and morbidity of the procedure. This advanced procedure combined bypass grafting to the anterior and posterior regions of the heart while delivering TMR plus stem cells to areas of the heart muscle that could not be bypassed. The PHOENIX Revascularization Delivery System provided precise and efficient cell implantation into and around the TMR channels."
Dr. Wan has performed over 400 adjunctive TMR procedures to date. His understanding that the thermoacoustic energy wave of Holmium:YAG TMR stimulates tissue around the laser channels promoting angiogenesis motivated him to apply the laser therapy with stem cells in areas of the heart that could not be bypassed. He has treated 20 patients with the combination procedure to date using separate sterile syringe application of stem cells after completing TMR channels in the targeted areas.
Dr. Wan explained, "As Holmium:YAG TMR has been shown to stimulate microvascular growth in the tissue surrounding the laser channel, our goal in this advanced combination procedure is to target the delivery of stem cells to the thermoacoustic stimulated area of new vessel growth surrounding the Holmium: YAG laser channels. This stimulated tissue zone signals the body's healing system to deliver stem cells, and our goal is to increase the vascular response and clinical benefit by delivering a large volume of the patients own stem cells to the targeted area during the initial stages of angiogenesis."
He continued, "The safety and feasibility of autologous stem cell therapy in the treatment of advanced cardiac disease is well documented. There is exciting potential of stem cells in providing improved long-term outcomes in cardiac patients. The PHOENIX Revascularization System addresses the need for precise, targeted cell delivery. We expect to optimize uptake and activation of these potent cells by targeting the Holmium:YAG thermoacoustic energy stimulated tissue zone at the time of surgery. Ultimately, we hope to see improved function in all areas of his heart, including the infarct area."
"The early outcome of this procedure was favorable, with the patient in recovery with no arrhythmia," stated Dr. Wan. "This advanced combined procedure utilizing the PHOENIX Revascularization System represents a worldwide first, and we intend to perform further evaluation for clinical safety and feasibility of this technique utilizing this advanced combination device."
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; 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, 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 CorporationCONTACT: Michael J. Quinn, Chairman and CEO, +1-714-649-5050, or ChristineG. Ocampo, Sr. VP, CFO, +1-714-649-5066, both of Cardiogenesis Corporation
