Internal Funding Round will Enable Completion of Breast Ultrasound Screening Application, Completion of the SOMO-INSIGHT Clinical Study and Fuel Next Generation Technology Development
SUNNYVALE, Calif.--(BUSINESS WIRE)-- U-Systems, Inc., the leader in automated breast ultrasound technology, announced today the completion of a $6.5 million funding round. The additional capital came exclusively from existing U-Systems investors and affiliates including iD SoftCapital Group, Lumira Capital, PIIH, Radius Ventures, and Sycamore Ventures.
"This funding represents an important confidence vote from our investors. The additional funds will enable us to complete our Pre-Market Approval (PMA) submission to the U.S. Food & Drug Administration (FDA), complete the SOMO-INSIGHT Clinical Study as well as continue development of the next generation automated breast ultrasound system,” said Ron Ho, president and CEO of U-Systems.
“Ultrasound is a proven tool for the diagnosis and treatment of breast cancer. However, it has not typically been used during the screening process. Several large studies have shown that supplementing mammograms with ultrasound for women with dense breast tissue can increase detection from 48 to 97 percent,” added Ho. “New approaches to improve early detection in women with dense breasts are clearly needed. We have dedicated significant time and resources to establishing a solid scientific basis for the use of automated breast ultrasound as a cancer screening tool for women with dense breast tissue.”
U-Systems is the leader in developing automated breast ultrasound systems and the sponsor of the SOMO•INSIGHT multi-center study that will enroll up to 20,000 women at clinical study sites in the United States to determine the sensitivity of mammography and somo•v Automated Breast Ultrasound Systems (ABUS) together, compared to mammography alone for women with dense breast tissue. The U-Systems somo•v Automated Breast Ultrasound System (ABUS) is 510(k) cleared, for use as an adjunct to mammography. The device has CE mark approval for breast ultrasound screening in Europe. For more information, please visit our website at http://www.u-systems.com.
For U-Systems, Inc.
Chris K. Joseph, 510-435-4031
KEYWORDS: United States North America California
INDUSTRY KEYWORDS: Technology Other Technology Health Hospitals Medical Devices