Dear Friend,

Since its inception in 1998, CardioVascular BioTherapeutics, Inc. (CVBT) has been dedicated to finding a solution to patients suffering—and even dying—from cardiovascular diseases. As a result and consequence of my personal experience as a cardiovascular surgeon with these patients—forming the majority of all hospitalized patients in the Western world—I strongly felt obligated to develop new and better treatment modalities for patients entrusted to me. The basic reason for this over-riding ambition is my experience with the limitations of existing treatment techniques, i.e. balloon angioplasty (PTCA) and bypass surgery (CABG), particularly in patients with advanced coronary heart disease. Quite often in the operating theatre it became apparent that the given conventional treatment for many patients was not efficient or sophisticated enough, to provide them with sufficient long term improvement of their coronary circulation and myocardial perfusion. The induction of neo-angiogenesis by the human (protein) growth factor FGF-1141 became a very real solution—and a new hope for many patients with advanced and diffuse coronary heart disease. Thus, angiogenic treatment of these patients was introduced into the scientific community, and simultaneously into the clinic. Since then, CardioVascular BioTherapeutics, Inc., has made continuous and significant progress—and furthermore, the Company has added new medical indications for its angiogenic therapy, including wound healing disorders (both diabetic and venous stasis ulcers), peripheral arterial disease (PAD), chronic back pain, and stroke—with all being diseases having in common a lack of adequate arterial perfusion in tissues and organs.

I am very pleased to report substantial progress and advancement for CardioVascular BioTherapeutics, Inc., in particular for this year—2007, and look forward to a very promising 2008 and beyond, especially relating to new developments in our company’s Research & Development efforts, as well as new initiatives in our clinical trials. As I mentioned in my letter one year ago—when the last patient of our Coronary Heart Disease trial had received their angiogenic treatment—the Phase I Heart trial was completely enrolled, and this year the final one year post-treatment visits were completed. The independent DSMC (Data and Safety Monitoring Committee) did not find any significant or unexpected safety concerns, and the activity of the treatment with the Company’s active pharmaceutical ingredient (API), FGF-1141, confirmed the preceding clinical trials in Germany. With these excellent results in Phase I, CardioVascular BioTherapeutics, Inc., can now move forward to focus on the international Phase II Heart trial in patients with severe Coronary Heart Disease (CVBT-141H).

During the last year, the final details of the Phase I Peripheral Arterial Disease (PAD) trial were discussed and outlined, and the Company received authorization from the FDA to start the trial (CVBT-141C), scheduled to commence shortly after the final approvals are obtained from the Institutional Review Boards of our clinical trial sites. Furthermore, the Phase I Wound Healing trial achieved substantial progress with close to 90% of patients now enrolled and treated with no safety concerns noted (CVBT-141B). Finally, the proof-of-concept trial using our drug product for the treatment of chronic back pain related to impaired arterial perfusion (CVBT-141E) is actively under way in Eastern Europe.

In addition, the Company is continuously performing basic scientific research through its specialized and renowned scientists and consultants. This research includes such areas as diabetes mellitus, heart failure, osteoporosis, and —in particular—stroke. I am very pleased that our pre-clinical research into stroke is producing very encouraging results, in both acute and chronic animal models of stroke. As is common knowledge, despite many medical efforts, the treatment options for patients suffering an acute stroke, or presenting in a chronic stroke setting, have been very limited for many years, with no causative treatment available. With FGF-1141, CardioVascular BioTherapeutics, Inc., offers a possible new dimension into an effective treatment for stroke victims, which will offer them a possible new hope.

In surprising contrast to the substantial progress made in the field of clinical trials and scientific research, Cardio-Vascular BioTherapeutics, Inc., met with a decrease of its share price during the course of the year 2006. There may be different reasons for this effect, however one explanation may be that the fundamental difference between fundamental “protein therapy” (as with  FGF-1141) and “gene therapy” is still not well understood by investment bankers and institutional investors (and their analysts, too!). CardioVascular BioTherapeutics, Inc., therefore, has increased its efforts to “educate” the public regarding this important distinction—by reminding them of the proven potential and efficacy of its protein therapy, FGF-1141. We have included on the Company’s web-site (www.cvbt.com), a number of published papers describing that difference between protein and gene therapy. 

Being traded only on the bulletin board (OTC-BB, symbol: CVBT.OB) also may have been part of the rather disappointing market valuation and market acceptance. Enforced and supported by the given fact that many of CVBT’s shareholder are based in Europe, the management decided to list CVBT’s shares at the London Stock Exchange. This goal is set to become a reality in 2007. CardioVascular BioTherapeutics, Inc., being Sarbanes-Oxley compliant, also was forced to increase its administrational efforts to stay current with such compliance.

I would like to cordially thank you—for your continuous trust in the management of CardioVascular Bio-Therapeutics, Inc., and in the committed CVBT staff, and for your ongoing support. I thank all members of CVBT’s scientific and administrative staff—for their passionate and steadfast daily work.

We all know that CVBT is owned by its shareholders —you are CVBT. And we all agree that we have to fulfill our mission by obtaining regulatory approval for our drug products – thus, giving a new chance of life for critically ill patients suffering from cardiovascular diseases.

Thomas J. Stegmann, M.D., Ph.D., FETCS
Co-Founder
CardioVascular BioTherapeutics, Inc.

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