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The Cost of Care


        
Diabetes is the world's most common metabolic disease. In 1995, market sources estimated that there were 13 million diabetics in the United States or approximately 4.5% of the U.S. population. There are 21 million diabetics in Europe and as many as 90 million worldwide. Type 1 patients compose from 5% to 10% of the total number of diabetics in the U.S. or approximately one million patients. An additional 1.5 million Type 2 diabetics also take insulin. There are approximately 500,000 to 600,000 new patients annually in the U.S., of which 35,000 to 50,000 are Type 1 diabetics. Approximately 25 percent of the new Type 2 patients will also take insulin.
 
        Data derived from the National Medical Expenditure Survey database indicates that in 1995, diabetes accounted for over 10% of total U.S. health care expenditures, or approximately $112 billion. In 1992, the American Diabetes Association estimated that another $47 billion was spent in indirect costs, such as lost wages. Other sources have estimated that indirect costs may actually exceed the direct costs. Complications of the disease include amputations of toes and feet, blindness, ulcers, nerve damage and cardiovascular, peridental, and kidney disease. Approximately 30% to 40% of people with Type 1 diabetes will develop diabetic nephropathy leading to kidney dialysis and renal transplants. Overall, diabetes is the fourth leading cause of death in the U.S.
 
        Current therapies, including insulin shots or oral hypoglycemic medication modulate blood glucose, but can not consistently maintain the diabetic's blood glucose at normal levels. The Diabetes Control and Complications trial, a nine-year NIH study, demonstrated that maintaining blood glucose at normal levels reduces by approximately 60% the risk of development and progression of diabetes complications. However, there is no therapy which supplies insulin in response to changes in blood glucose with the speed and precision of functioning islets. The Company believes that successful transplantation of islets capable of providing constant glucose control will eliminate or ameliorate the complications of the disease.