CARDIOVASCULAR BIOTHERAPEUTICS, INC. (OTCBB: CVBT)

Dear StockUpTicks Reader,

As many of our dedicated readers are well aware, we frequently publish as to our affinity for the biotech sector and the many opportunities within it. We just don’t see how the throng of aging baby boomers heading toward the health care door can’t impact the biotech, pharma and healthcare sectors enormously.  So, we’re always on the lookout for novel technologies within the aforementioned arenas.

One such company may have just crossed our electronic path and today’s full StockUpTicks profile of CardioVascular BioTherapeutics Inc. (OTCBB: CVBT) sets the table for you to grasp and understand what it is that the company does and why this may be important. As always, we will attempt to deliver this content in an easy to understand and no-hype manner.

What strikes us most about CVBT is the specific niche of its business plan. Some of you are undoubtedly aware that 60 million people in the U.S. suffer from heart disease.  Without a doubt there is a tremendous need for a safer and lower-cost treatment for heart disease – and CVBT provides one.  Most briefly explained, CVBT has developed a protein therapy (not a gene therapy) that improves and increases the vascular tributaries providing blood flow to the heart, which in turn heals areas damaged by heart attack and stroke. 

CVBT is currently working to confirm the medical benefits of this protein drug candidate through human clinical trials authorized by the U.S. Food and Drug Administration (FDA).  As most of you probably know, human trials are not the first phase of FDA approval.  A company must have significant indication of likely success to get this far.

So please take a moment to peruse today’s profile below and be sure to keep an eye on CVBT.
 

About CardioVascular BioTherapeutics

In two separate clinical trials in Germany in the mid-1990s conducted by Dr. Thomas J. Stegmann, a protein identical in structure to Cardio Vascu-Grow™ prompted the growth of new blood vessels in the hearts and increased the pumping capacity of the hearts in the "no option" heart patients treated. 

CVBT is currently working to confirm the medical benefits of this protein drug candidate through human clinical trials authorized by the U.S. Food and Drug Administration (FDA). The FDA clinical trial for no-option heart patients commenced in August 2004, with a network of six major medical centers conducting the trial.  To date, 60 human no-option heart patients have been treated with Cardio Vascu-Grow™ and in Dr. Stegmann's German trial using a protein identical in structure to Cardio Vascu-Grow™.
 

CVBT recently announced that its Investigational New Drug Application ("IND") to the U.S. FDA had been allowed and the company is now authorized to commence its Phase I clinical trial in diabetic patients with foot ulcers and/or open leg wounds.  Wound healing requires angiogenesis for the healing process to occur, making this indication an attractive target for treatment with Cardio Vascu-Grow™.  In animal models, Cardio Vascu-Grow™ has been shown to be a potent stimulator of wound healing, almost doubling the rate at which a wound will heal.  People with diminished healing abilities, including diabetics and the elderly, could greatly benefit from an agent that could stimulate the growth of new blood vessels in the wounded area.  10 Million Patients Suffer from Diabetic Leg Ulcers, Bed Sores and Surgical Wounds.

CVBT is committed to conducting additional clinical trials to establish the positive effect of its drug candidate aimed at improving the quality of life for those suffering from heart disease, stroke, diabetic wounds, or peripheral vascular disease, and CVBT management pledges to continue exploration for additional applications of Cardio Vascu-Grow™.
 

The Need for Cardio Vascu-Grow™

• 38% of all deaths in the United States are caused by cardiovascular disease 
• 13.2 million suffer from coronary artery disease
• 4.8 million people in the U.S. have suffered strokes
• 7.8 million people in the U.S. will have a heart attack this year

Through marketing efforts, CVBT intends to target potential patients, physicians involved in the delivery of cardiovascular medical services, hospitals and third party payers of medical services.  Management also intends to register Cardio Vascu-Grow™ for sale in other countries after meeting their individual requirements for approval.

Once Cardio Vascu-Grow™ receives FDA approval for the treatment of no option heart patients, CVBT will focus on developing this drug for use in cardiovascular disease.  Many medical conditions characterized by the lack of arterial blood supply - such as certain forms of stroke, wound healing, lower extremity peripheral vascular disease (PVD) and renal disease - could be amenable to this therapy and CVBT management intends to expand into these areas as the Company grows.

The CVBT Business Strategy

• Obtain FDA approval of Cardio Vascu-Grow™ for the treatment of "No-Option Heart Patients" in the U.S.
• Rapidly evaluate Cardio Vascu-Grow™ as a new wound healing agent in U.S. clinical trials
• Secure approval for reimbursement from third-party payers
• Implement commercial volume manufacturing capacity for Cardio Vascu-Grow™
• Market Cardio Vascu-Grow™ to potential patients, focusing on patients with cardiovascular disease for whom no traditional medical treatment exists
• Market to third-party payers based on the anticipated economic benefit and improved quality of patient care offered by Cardio Vascu-Grow™
• Market to leading cardiac hospitals and physicians to have Cardio Vascu-Grow™ adopted as "standard of care" based on the anticipated economic benefits and improved patient care features of the product
• Continue testing Cardio Vascu-Grow™ in animal models  of stroke,  lumbar ischemia and intestinal ischemia, and  continue to explore additional  medical  applications  for Cardio Vascu-Grow™ in diseases caused by by poor blood perfusion
• Initiate by the second quarter of 2006 clinical trials with Cardio Vascu-Grow™ in patients with peripheral vascular disease of the legs.
• After successful completion of animal studies, initiate clinical trials in patients receiving bypass surgery or other invasive coronary artery treatments as an adjunct to such treatments
• Finalize development of and obtain FDA approval for its catheter delivery system for Cardio Vascu-Grow™

Vision: The purpose and development of CardioVascular BioTherapeutics, Inc. is to assist in extending life through the use of Cardio Vascu-Grow™, our drug candidate that addresses cardiovascular disease by increasing the blood supply to ischemic areas, tissues and organs of the body. Once perfusion is established through the growth of new blood vessels in areas affected, patients with cardiovascular disease can experience an increase in life expectancy and quality of life.

Mission: Our mission at CardioVascular BioTherapeutics, Inc. is to provide treatment for different types of cardiovascular disease.  CVBT is determined to achieve this humanitarian objective, which could potentially help millions of people who suffer from such diseases.
 

CVBT Science, Research, and Product Pipeline

CVBT is committed to maintaining a cutting edge and state-of-the-art research and development team to explore additional medical indications for Cardio Vascu-Grow.  CVBT is also committed to identifying and developing second and third generation versions of Cardio Vascu-Grow™ to bring forward new drugs that may have enhanced activity for specific medical indications.  This CVBT web site offers in depth information about its science and medical technology.

Therapeutic biologicals are protein drugs that, in most cases, are natural products found in our bodies. Therapeutic biologicals are complex drugs and must undergo rigorous testing for purity and biological potency before the FDA will approve them. Cardio Vascu-Grow™ is a therapeutic biological, a member of a family of proteins that are potent stimulators of angiogenesis or new blood vessel growth.  In addition, Cardio Vascu-Grow™ has biological potencies regarding nerve cell protection and repair, and also in stimulating cartilage and bone cell regeneration.  Since Cardio Vascu-Grow™ is a human protein, it is highly unlikely to cause an allergic or immunogenic reaction in patients.

CVBT is now focused on receiving approval from the Food and Drug Administration (FDA) to market Cardio Vascu-Grow™ in the United States, for the treatment of no-option heart patients, by conducting FDA-authorized clinical trials in the U.S.  These U.S. clinical studies attempt to confirm and extend, by testing different doses of the drug, the results of Dr. Stegmann’s previous clinical studies in Germany.

In July 2004, CVBT obtained authorization from the FDA to proceed with a Phase I human clinical study for Cardio Vascu-Grow™. For the most current information on the status of these trials, including many details about the process, please visit www.clinicaltrials.gov. 
*To read a summary of the current U.S. clinical trials in a pdf format, click here.

On September 13, 2005 CVBT announced that its Investigational New Drug Application ("IND") to the U.S. FDA had been allowed and that it was authorized to commence its Phase I clinical trial in diabetic patients who have foot ulcers and/or open leg wounds.  CVBT will be testing two doses of its wound healing agent, Cardio Vascu-Grow™ for topical application. The principal purpose of this first study is to test the safety and tolerability of Cardio Vascu-Grow™ for topical application in the target patient population.  Earlier animal studies by CVBT in diabetic mice with experimental wounds, showed that Cardio Vascu-Grow™ for topical application significantly improved the healing rate of the wounds when compared to control animals.

The annual treatment costs for diabetic wound healing and the healing of bed sores is in the $5-7 billion range, and it is estimated by the U.S. Healthcare Finance Administration that approximately 3 million patients per year suffer from wound healing problems. 

2005 News From CVBT

CVBT Leadership

Thomas J. Stegmann, M.D.

Dr. Thomas J. Stegmann’s discovery of ways to stimulate growth of new blood vessels in the human heart opens up an exciting new area of biotechnology and medical treatment for cardiovascular disease.  His research and subsequent trials have been articulated in an acclaimed volume, New Vessels for the Heart: Angiogenesis as New Treatment for Coronary Heart Disease: The Story of its Discovery and Development, published in 2005.

New Vessels for the Heart by Thomas J. Stegmann, M.D.

This publication explains his discovery, the first scientific steps, and the 12-year journey that led to  the current status of CVBT’s human clinical trials in the United States.  Dr. Stegmann describes the fascinating extension of that new treatment principle to represent an overwhelming potential for the therapy of a variety of diseases,  such as stroke, wound-healing disturbances, chronic back pain, neurological disorders and others. Now, you can read the story of the development and discovery of Cardio Vascu-Grow™ for yourself  in Dr. Stegmann’s book.

Dr. Stegmann is the cardiac surgeon who pioneered the procedure upon which CVBT was founded.   For the past 12 years, he has been working in the area of neo-angiogenesis and human growth factors, prompting a discovery that opens a new area of biotechnology and medical treatment for the treatment of cardiovascular disease. Besides various scientific publications, he has since authored New Vessels for the Heart, the story of his discovery and its development.

Since December 1984, Dr. Stegmann has held the position of Professor of Surgery and Director of the Department for Thoracic and Cardiovascular Surgery at the Fulda Medical Center in Germany, a major medical and teaching hospital serving the University of Marburg and the greater Frankfurt, Germany area. He is also a member of the faculty of Hannover Medical School in Germany. He received his medical degree (summa cum laude) from Heidelberg University, Heidelberg, Germany.

Daniel C. Montano brings a wide range of management experience to his roles, having served as CEO of 14 operating companies in industries such as real estate, high technology, medical technology, biotechnology, food products, financial institutions, and service companies.  From 1981 until 2004, Montano was a member of the Board of Directors of Helen of Troy, Ltd, a Texas company with revenue of over $450 million.  He also spent 30 years as an investment banker.  Montano received his MBA from the University of Southern California and his undergraduate degree from California State University, Los Angeles.
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Financial Highlights For CVBT

To Contact CVBT

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