Leading Osteoporosis Researcher to Explore Potential Use of Protein Therapy to Treat Osteoporosis

Business Wire, Oct 5, 2006

Study to Determine if Cardio Vascu-Grow(TM) Stimulates New Bone Formation

LAS VEGAS -- CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT), a biopharmaceutical company focused on the development of protein-based drugs for the treatment of cardiovascular disease, today announced that it signed a sponsored research agreement with Tufts University School of Medicine to study the potential use of human fibroblast growth factor-1, the active component of Cardio Vascu-Grow[TM], to treat patients with osteoporosis.

Michael Rosenblatt, M.D., professor of physiology and medicine at Tufts University School of Medicine, will conduct a six-month study in an animal model of osteoporosis to test human fibroblast growth factor-1 for its activity to reverse bone loss.

According to the National Osteoporosis Foundation, 10 million individuals are estimated to already have osteoporosis in the U.S., and almost 34 million more are estimated to have low bone mass, placing them at increased risk for osteoporosis. Current marketed therapies for osteoporosis, including the bisphosphonates of which Merck's Fosamax is a member, primarily act by inhibiting the breakdown of bone in osteoporosis, but do not stimulate new bone formation. The promise of a bone growth factor to actually add back lost bone would be a significant advance in the treatment of this debilitating disorder.

"This new initiative with Tufts University School of Medicine marks the company's first entry into the field of osteoporosis therapy. If the results prove favorable, our next step is to commence clinical trials to further study this potential therapy option," said Daniel C. Montano, president and CEO, CardioVascular BioTherapeutics. "The ability to restore lost bone would be a tremendous step forward in the treatment of osteoporosis and we are delighted that Dr. Rosenblatt, an internationally-recognized expert in bone biology and calcium-regulating hormones, is leading this study."

In addition to his research role, Michael Rosenblatt is dean of Tufts University School of Medicine. Prior to assuming this position, Dr. Rosenblatt was Professor of Medicine at Harvard Medical School, and before that he served as Vice President of Research and Development at Merck & Co. where he led the clinical development efforts that culminated with the FDA approval of Fosamax for the treatment of osteoporosis. For more than 20 years he has made significant and important contributions to the understanding of the hormonal regulation of bone metabolism, and in the development of new therapies to treat bone disorders.

About CardioVascular BioTherapeutics

CVBT is a biopharmaceutical company developing drug candidates with Cardio Vascu-Grow[TM] as the active ingredient for a number of diseases characterized by inadequate blood flow to a tissue or organ. The company is currently conducting two FDA-authorized clinical trials: one in coronary artery disease in no-option heart patients, and one in impaired wound healing of the skin. Additionally, the company has completed pre-clinical studies in animal models of peripheral artery disease of the legs and stroke recovery. A foreign proof-of-concept clinical trial relating to chronic back pain believed to be caused by impaired or blocked lumbar arteries has also been initiated.

Cardio Vascu-Grow[TM] is a trademark of CardioVascular BioTherapeutics, Inc.

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 expectations for new research, progress with clinical trials or future business initiatives are forward-looking statements. Factors that might affect actual outcomes include, but are not limited to, results of future clinical and pre-clinical trials, differences in patient outcomes, FDA approval of CVBT drug candidates, market acceptance of CVBT products by customers, new developments in the industry, 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.