Breast health has emerged as a top public health priority
over the past decade. Breast cancer is the most common non-skin-related
malignancy, affecting more than 2 million women in 1999 (National
Cancer Institute). According to Medical Data International,
a woman is diagnosed with breast cancer every three minutes.
The American Cancer Society (ACS) projects that there will
be 192,200 new cases of breast cancer diagnosed in the U.S.
in 2001, and 40,200 women and 400 men will die from the disease
this year. According to ACS, breast cancer is the leading
cause of cancer death among women ages 40 to 55. Based on
current trends, approximately one of every eight women in
the U.S. will develop breast cancer during her lifetime.
Dobi System Potential Impact on the Breast Cancer Diagnostic
Breast Cancer Diagnosis
Physicians and researchers in the field widely acknowledge that
screening and proper diagnosis are essential for effective treatment
and management of the disease. In March 1997, the American Cancer
Society expanded its breast cancer screening guidelines to include
yearly mammograms for all women over 40 years of age. The National
Cancer Institute has also adopted these guidelines.
Mammography has been in use for over 75 years for both screening
and diagnostic applications. In cases that are referred for
biopsy, mammography has a specificity (ability to detect a
benign lesion) of only 20%, or less in younger women. It is
a well-established modality and considered the industry standard
against which other modalities are measured, but because of
its substantial specificity limitation, there is a great need
for an improved diagnostic tool to non-invasively differentiate
between malignant and benign lesions.
Due to these specificity limitations, current mammography
techniques result in surgical biopsies in the U.S. that cause
physical trauma to more than 1 million women at an estimated
cost of nearly $2 billion every year, with up to 80% of biopsy
results being benign or potentially avoidable. The DOBI ComfortScan(TM)
System has the potential to reduce unnecessary surgical biopsies.
In addition, millions of women could be spared the physical
and emotional trauma of surgical biopsy. The necessity to
solve these problems has heightened the Company's sense of
urgency in obtaining the necessary regulatory approvals and
introducing the product into the marketplace.