U-Systems somo•v Automated Breast Ultrasound system granted FDA PMA approvable letter

May 14 2012

U-Systems, the leader in automated breast ultrasound, announced today it has received a PMA approvable letter from the U.S. Food and Drug Administration's (FDA) for the company's somo•v® Automated Breast Ultrasound (ABUS) system. The somo•v ABUS system is the first ultrasound device to receive an approval recommendation from a FDA Advisory Panel and an approvable letter for breast cancer screening as an adjunct to mammography for asymptomatic women with dense breast tissue.

“The breast imaging community has known for some time that mammography does not work equally well in everyone, particularly the 40% of women in the United States who have dense breast tissue”

"The breast imaging community has known for some time that mammography does not work equally well in everyone, particularly the 40% of women in the United States who have dense breast tissue," said Ron Ho, President and CEO of U-Systems. "We are very excited to receive a PMA approvable letter for a breast cancer screening indication for the somo•v ABUS system, and to be one step closer to offering radiologists an important adjunctive screening tool which has the potential to find some 30 percent additional cancers that would not have been found with mammography. We are pleased that our development efforts, now supported by the FDA's scientific review of our safety and clinical data, are bringing us close to final PMA approval. With this response from the FDA, we will begin preparing for the launch of the somo•v ABUS system across the U.S."

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.

According to U-Systems' founder Bob Wang, who previously developed other important breast imaging technologies, such as low dose rare-earth screenings, which revived mammography screening, and mammography CAD, automated breast ultrasound was developed to address the specific economical and functional roadblocks to ultrasound screening. "After discovering that ultrasound could complement mammography in the early detection of breast cancer, we developed ABUS technology to improve breast ultrasound image quality, enhance patient comfort and reduce interpretation time. A distinguished group of breast imaging experts has greatly helped speed the development of ABUS with their tireless research and outstanding expertise. The approvable letter from the FDA is validation of this collective effort as we move closer to widespread availability of this important early detection tool for women with dense breasts."

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

Final approval of the Company's pre-market approval (PMA) application for the system remains subject to satisfactory review and inspection of U-Systems manufacturing facilities, methods and controls. The Company plans to work closely with the FDA to complete this final inspection.