With nearly 900 women dying from breast cancer each week in the United States alone, the management and employees of DII have a heightened sense of urgency toward the successful development, approval and introduction of the DOBI technology into the marketplace. In 1997, state of the art mammography was sensitive enough to identify only 80~85% of cancers (i.e., 15~20% false negative results). Studies also indicate that about 100 out of every 10,000 women screened are biopsied, and, of these, only 15~20 confirm cancer, (i.e., the overall false-positive rate is 80~85%) and, hence, did not need a biopsy. This creates a large opportunity for a new, more effective diagnostic and screening technology.
Mammography Performance Today
DOBI Expected Performance
Sensitivity
80~85%
90% or more
Specificity
15~20%
75% or more
The Company's technology, built on six domestic and international patents, when fully developed, is expected to be superior to all other available technologies, providing physicians with better, more reliable data for screening, diagnosing, and treating breast cancer patients. Today, the most important aspect of DII's development is the Company's ability to gather the necessary clinical data to quantify and qualify these claims properly and completely for review and PreMarket Approval (PMA) by the FDA. Once this approval has been obtained, the Company can begin to market the DOBI system nationwide.
|
