U-Systems, based in Sunnyvale, Calif., is a leader in automated breast ultrasound technology and the sponsor of the SOMO•INSIGHT multi-center study. Its somo•v Automated Breast Ultrasound System (ABUS) is 510(k) cleared for use as an adjunct to mammography and has CE mark approval for breast ultrasound screening in Europe. The company is running SOMO•INSIGHT, a U.S. study planned to enroll up to 20,000 women to evaluate the sensitivity of mammography plus somo•v ABUS versus mammography alone for women with dense breast tissue. U-Systems cites evidence that supplementing mammograms with ultrasound can increase detection from 48 to 97 percent and is focused on improving early detection in women with dense breasts. Current plans include completing a Pre-Market Approval (PMA) submission to the U.S. FDA, finishing the SOMO•INSIGHT clinical study, and continuing development of the next-generation ABUS. The company recently secured additional capital to fund those regulatory, clinical, and product-development activities. U-Systems, based in Sunnyvale, California, designs, manufactures and supplies automated breast ultrasound (ABUS) systems for breast cancer detection. Its somo•v™ Automated Breast Ultrasound System is FDA-cleared and CE-Marked. The company positions ABUS as a complement to digital mammography, particularly for women with dense breasts. U-Systems plans to complete a clinical trial to evaluate whether somo•v used alongside digital mammography is more sensitive at detecting breast lesions than mammography alone. The recently completed financing will enable the company to finish that clinical trial. Investors in the round include both new and existing backers.

Total raised

$17M

Funding rounds

2

Latest round

Equity

Latest activity

May 2011