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German No-Option Heart Patients, With Only a Two Year Life Expectancy, Celebrate Ten-Year Reunion After Being Treated With Innovative Protein Identical to CVBT's Cardio Vascu-Grow(TM) Currently in U.S. FDA Clinical Trials

Posted on: Monday, 19 September 2005, 15:00 CDT

CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) announced today that its Chief Clinical Officer, Thomas Stegmann, M.D., met with a group of no-option heart patients whom ten years ago received his innovative protein designed to grow new blood vessels around clogged arteries. Also present were patients from his second clinical trial in Germany conducted 5 years ago.

Mr. Daniel Montano, CEO of CVBT, was also present at the 10 year anniversary celebration in Germany and stated, "I am so pleased that Dr. Stegmann's treatment gave these 40 patients many more years of their lives to enjoy. The number of patients all over the world that suffer from Coronary Heart Disease is measured in the millions and is growing rapidly, and Cardio Vascu-Grow(TM), if approved, could be a major new medical therapy for these very sick patients. I believe our drug candidate could greatly reduce the pain and suffering as well as dramatically lower the cost of treating these patients." The total U.S. population of patients suffering from Coronary Heart Disease is approximately 13 million according to recent statistics from the American Heart Association.

According to Dr. Stegmann, cardiovascular surgeon and co-founder of CVBT, the forty no-option heart patients treated in Germany had a life expectancy of approximately 2 years at the time they were treated. "As a physician and surgeon it is so very gratifying to me to see how this therapeutic protein has changed and extended the lives of these 40 patients. I am also pleased that we are seeing consistent results to date in the current U.S. trials utilizing the identical therapeutic protein that was administered to these 40 patients."

Dr. Stegmann added, "I am hopeful that Cardio Vascu-Grow(TM), the trade name for the protein therapeutic currently undergoing study in the U.S., could eventually become a safe and effective treatment for Coronary Heart Disease worldwide." Dr. Stegmann's earlier work in Germany has been cited for its potential to be a breakthrough therapy for patients with severe Coronary Heart Disease.

The current U.S. clinical trial is a multi-center, dose escalation trial to evaluate the safety and tolerability of Cardio Vascu-Grow(TM), a protein that induces angiogenesis, or new blood vessel growth. Patients enrolled are considered no-option patients because they are not deemed eligible for traditional interventional therapies including bypass and stenting procedures. Although this is primarily a safety study, the company is also collecting and evaluating efficacy data in this current trial that is valuable in planning future clinical studies.

CVBT is also exploring the use of Cardio Vascu-Grow(TM) in other settings of Coronary Heart Disease. These include the use of the protein therapy as an adjunct treatment when individuals are receiving a bypass procedure and in patients with less severe forms of angina. CVBT is actively engaged in developing a catheter system to introduce Cardio Vascu-Grow(TM) to these angina patients in a manner that does not require surgery.

CVBT is a biopharmaceutical company focused on the treatment of a broad range of cardiovascular diseases where there is poor blood perfusion in the tissues. CVBT recently received authorization from the U.S. FDA to begin a new series of clinical trials in diabetic wound healing, a second major medical indication for Cardio Vascu-Grow(TM). Animal experiments have indicated that Cardio Vascu-Grow(TM) may also have widespread utility in a number of additional diseases characterized by poor blood perfusion, including stroke and peripheral vascular disease of the legs.

CardioVascular BioTherapeutics, Inc. (Stock symbol:CVBT) is a biopharmaceutical company focused on developing a new drug for the treatment of cardiovascular diseases where the growth of new blood vessels can improve the outcome for patients with these diseases. Its drug candidate, Cardio Vascu-Grow(TM), is designed to facilitate the growth of new blood vessels in the heart and other tissues with an impaired vascular system.

This news release contains forward-looking statements that involve risks and uncertainties. Actual results and outcomes may differ materially from those discussed or anticipated. For example, statements regarding our future revenues, cash usage and our cash flow breakeven point are forward looking statements. Factors that might affect actual outcomes include, but are not limited to, FDA approval of Cardio Vascu-Grow(TM), market acceptance of CardioVascular BioTherapeutics, Inc. products by our customers, future revenues, future expenses, future margins, cash usage, and financial performance. For a more detailed discussion of these and associated risks, see the company's most recent documents filed with the Securities and Exchange Commission.

Cardio Vascu-Grow(TM) is a trademark of CardioVascular BioTherapeutics, Inc.

Source: Business Wire

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