SOMO·INSIGHT Clinical Study Detects First Cancer in Mammographically Negative Breast Screening Patient at OSF Saint Francis Medical Center

SAN JOSE, Calif. & PEORIA, Ill.--(BUSINESS WIRE)--U-Systems, the leader in dedicated breast ultrasound systems, together with Medical Director Jessica A. Guingrich, MD of OSF Saint Francis Medical Center, Susan G. Komen Breast Center and Centers for Breast Health announced that they have initiated the SOMO·INSIGHT Clinical Study. The first participants have been enrolled and the first pathologically confirmed cancer has been detected in a mammographically-negative screening patient. The clinical study is examining whether Digital Mammography along with the somo•v™ Automated Breast Ultrasound (ABUS) is more sensitive to detecting breast lesions when compared to Mammography alone in women with dense breasts.

“to serve persons with the greatest care and love.”

The initiation of this nationwide study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improved cancer detection. Screening mammography can be limited in women with dense breasts and these women have a higher risk of breast cancer. ABUS uses ultrasound (sound waves) at a safe frequency to create images of the internal breast tissue, unlike mammography, which uses radiation. Ultrasound has been shown to find cancer not visible with mammography in women who have dense breasts. A new approach to improving breast cancer detection is critical for women with dense breasts who undergo mammography. It is for this reason that U-Systems developed the somo•v and is sponsoring the SOMO·INSIGHT clinical study.

Dr. Jessica A. Guingrich, Principal Investigator for the SOMO·INSIGHT Clinical Study at OSF stated, “We are excited to be a part of this clinical study and to be able to bring new technology for earlier cancer detection to our patients. Shortly after initiating the clinical study, we identified the first pathologically-confirmed cancer in a mammographically negative patient. Fortunately the patient was enrolled in the SOMO·INSIGHT study and the somo•v Automated Breast Ultrasound identified a region of interest which was confirmed on biopsy to be an Infiltrating Ductal Carcinoma of the Breast. The patient is now undergoing treatment for this cancer.”

Ron Ho, President and CEO of U-Systems said, “We are pleased to be initiating the SOMO·INSIGHT Clinical Study with Dr. Guingrich of OSF Saint Francis Medical Center. This is a major milestone for U-Systems, and through our partnerships with the Susan G. Komen Breast Center and Centers for Breast Health, we believe this will be a remarkable step towards new advancements in breast cancer screening. The use of the somo•v™ ABUS in combination with mammography will aid the physician in earlier detection of breast cancer and has already been invaluable for this first confirmed cancer at OSF Saint Francis Medical Center.”

About U-Systems

U-Systems is the leader in developing dedicated breast ultrasound systems. For more information, please visit our website at http://www.u-systems.com. The U-Systems somo•v Automated Breast Ultrasound System (ABUS) is currently cleared under 510(k). The device is indicated for use as an adjunct to mammography for B-mode ultrasonic imaging of a patient’s breast when used with an automatic scanning linear array transducer. The device is not intended to be used as a replacement for screening mammography.

About OSF Saint Francis Medical Center

OSF Saint Francis Medical Center is a 616-bed academic and regional medical center in Peoria, Illinois with 5,700 employees and more than 800 physicians on staff. It is a Level 1 trauma center with the most active medical transport system (Life Flight) in Illinois. It is home to the Children’s Hospital of Illinois, Illinois Neurological Institute and OSF Saint Francis Heart Hospital. We are devoted to offering our patients access to new forms of treatment. Our goal is to be involved in Research which focuses on finding the best treatments currently available for our patients. This endeavor is directly related to the OSF Mission, "to serve persons with the greatest care and love."