Cardiogenesis Reacts to Published Research Demonstrating Potential of TMR Plus Gene Therapy.
Cardiogenesis Corporation (OTCBB:CGCP:OB), a leading developer of surgical products and accessories used in angina-relieving procedures, issued the following statement today in reaction to a study published in the current issue of The Journal of Thoracic and Cardiovascular Surgery.
According to Michael Quinn, Chairman and CEO of Cardiogenesis: "As highlighted by this noteworthy research, we believe that the future of TMR lies in minimally-invasive, closed-chest delivery tools and techniques, with potentially synergistic delivery of biologic enhancements. The impressive work by Dr. Horvath and his co-authors, as supported by the American Heart Association and Selective Genetics Inc., is advancing the understanding of TMR's potential beyond the demonstrated significant patient benefits as a primary or sole therapy. We are encouraged by his continued contribution in advancing the scientific understanding and clinical application of TMR, and in helping to advance therapies to the growing group of patients suffering from advanced heart disease who have limited therapeutic options."
Cardiogenesis's products and systems specifically are used for Transmyocardial Revascularization (TMR) and Percutaneous Myocardial Channeling (PMC) procedures.
The study shows a significant increase in angiogenesis within the heart as a result of a combination of TMR and matrix adenoviral fibroblast growth factor-2 (AdFGF2) gene therapy. The results demonstrated a clear improvement versus either therapy conducted alone.
In the article entitled, "Improvement of Myocardial Contractility in a Porcine Model of Chronic Ischemia using a Combined Transmyocardial Laser Revascularization and Gene Therapy Approach," the authors state "(t)he key limitation of growth factor protein therapy seems to be the difficulty in achieving sustained therapeutic protein concentrations at the intended sites."
The study's design used a chronic ischemic porcine model in comparing the response of four treatment groups-TMR alone, adenoviral FGF-2 in a collagen-based matrix alone, adenoviral FGF-2 in a collagen-based matrix combined with TMR, and saline-formulated adenoviral FGF-2. The authors reported that histological analysis confirms the matrix formulated vectors present in TMR channels post treatment and that arteriogenesis is enhanced in the TMR plus AdFGF2 treated areas compared to either therapy alone. They concluded the combination therapy provides a "salutary angiogenic response that has significant clinical implications and in planned translational work may provide a better treatment in combination than either therapy alone."
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 March 31, 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.
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|Date:||Jun 10, 2005|
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