Breast Health Today

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 Process

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.


American Cancer Society

National Alliance of Breast Cancer Organizations

National Breast Cancer Coalition

National Cancer Institute

Susan G. Komen Breast Cancer Foundation

Y-Me National Breast Cancer Organization

Investigational Device: Limited by Federal Law to Investigational Use Only. Copyright ©2000-2001 DOBI Medical Systems All Rights Reserved.
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