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CVBT News CardioVascular BioTherapeutics Initiates Study on the Treatment of Peripheral Artery Disease

LAS VEGAS--(BUSINESS WIRE)--CardioVascular BioTherapeutics, Inc. (OTCBB:CVBT) today announced that it is launching a new clinical trial to study the safety of a new drug candidate using Cardio Vascu-Grow™ as its active ingredient for the treatment of Peripheral Artery Disease (PAD). Cardio Vascu-Grow™ contains a protein that stimulates the growth and production of new blood vessels, a process called angiogenesis.

An estimated 8 million Americans suffer from peripheral artery disease, which occurs when blood vessels which feed the legs become blocked by atherosclerotic lesions, resulting in pain while walking, a condition termed “intermittent claudication.” This can evolve to more severe forms of the disease where circulation to the foot and leg become so reduced that amputation of the toes, foot, or leg is the only alternative. This disease increases in prevalence as people age or in patients with diabetes. This FDA-authorized Phase I clinical trial will test the safety of Cardio Vascu-Grow™ after it is injected into the legs of PAD patients, and will evaluate the growth of new blood vessels in the legs and the increase of blood perfusion into the ischemic leg muscles in these patients.

“Peripheral artery disease is a major health concern faced by millions of Americans, and left untreated, it increases the risk of heart attack, stroke, amputation, or death,” said Dr. Thomas J. Stegmann, co-founder of CardioVascular BioTherapeutics. “Better treatment options are needed for this disease, and regenerative treatments such as Cardio Vascu-Grow™, which enhance the body’s natural ability to regenerate tissues and organs, have the potential to radically reduce the mortality, and morbidity, and increase the quality of life of patients with peripheral artery disease.”

This multi-center study will involve medical centers in the United States. Three escalating doses of Cardio Vascu-Grow^TM will be tested in 24 patients that suffer from intermittent claudication. In addition, a group of control patients will receive a placebo dose of the drug to allow comparisons of safety and efficacy to guide subsequent clinical studies. The Phase I study will incorporate relatively new imaging modalities, including magnetic resonance imaging of the patient’s legs before and after treatment with Cardio Vascu-Grow^TM, in an effort to more accurately quantify the potential increase in blood perfusion that is anticipated in patients injected with the drug.

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. Currently, the company is conducting three FDA-authorized clinical trials: one in the area of coronary artery disease in no-option heart patients, one in the area of impaired wound healing seen in diabetics, and one in patients with peripheral artery disease. In addition, the company has initiated a clinical trial in Russia examining the potential of Cardio Vascu-Grow^TM to improve symptoms in patients with chronic back pain believed to be caused by impaired or blocked lumbar arteries. The company has also recently completed pre-clinical studies with Cardio Vascu-Grow^TM demonstrating efficacy in animal models of stroke recovery.

Cardio Vascu-Grow™ 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, 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.