FDA panel schedules review for U-Systems' somo•v ABUS system

U-Systems, the leader in automated breast ultrasound, today announced the somo•v® Automated Breast Ultrasound (ABUS) system has been scheduled for review by the Radiological Devices Panel of the U.S. Food & Drug Administration (FDA) on April 11, 2012. The FDA Advisory Panel review is the next step in U-Systems' premarket approval (PMA) application seeking a breast cancer screening indication for the somo•v ABUS system. The somo•v ABUS system is currently FDA-cleared for diagnostic use as an adjunct to mammography.

"We are very excited the somo•v ABUS system has been scheduled for review at the upcoming Radiological Devices Advisory Panel Meeting," said Ron Ho, president and CEO of U-Systems. "This is a significant milestone, not only for the company, but also for women with dense breast tissue. The limitation of mammography in women with dense breasts is well documented. This panel review, part of the FDA process for assessing new technology, brings us one step closer to an approved adjunctive screening tool for women with dense breasts. This is vitally important, because an estimated 40-45% of women in the United Stated have dense breast tissue."

Dense breast tissue not only increases the risk of breast cancer up to 4-6 times but also makes cancer more difficult to detect via mammography according to multiple large studies. One study, published in the New England Journal of Medicine, showed 35 percent of breast cancer goes undetected by mammography in women with dense breasts, as density masks appearance of tumors (Boyd, et al, NEJM 2007:356:227-36M). As breast density goes up, the accuracy of the mammogram goes down.

Over the past several years, U-Systems has worked with some of the nation's leading breast imaging experts to conduct a large, multi-center prospective clinical study to evaluate the ability of somo•v Automated Breast Ultrasound screening to improve cancer detection rates for women with dense breast tissue. The SOMO•INSIGHT Clinical Study, the largest trial ever undertaken by an ultrasound company, is designed to evaluate whether digital mammography in combination with the Automated Breast Ultrasound System is more sensitive than a routine screening mammogram alone in detecting breast cancer in women with dense breast tissue. More than 16,000 women have enrolled in the study at multiple breast imaging centers nationwide.

Using proprietary technology to automate the breast ultrasound imaging process, the U-Systems' somo•v ABUS system is ideally suited for the high-volume, screening environment. The somo•VIEWer™ Advanced 3D Workstation enables fast, accurate review and archive of patient exams, optimizing breast ultrasound screening workflow.