Radiology Regional Center First Breast Center in Southwest Florida to Initiate U-Systems SOMO·INSIGHT Study

FORT MYERS, Fla.--(BUSINESS WIRE)--U-Systems announced today that Radiology Regional Center has initiated participation in the SOMO•INSIGHT Clinical Study. The first breast center in Southwest Florida to participate, Radiology Regional Center is recruiting participants for the national clinical research study designed to evaluate whether digital mammography in combination with the somo•v™ Automated Breast Ultrasound System (ABUS) from U-Systems is more sensitive to detecting breast lesions when compared to Mammography alone in women with dense breasts.

“We are very excited to be initiating the SOMO·INSIGHT Clinical Study with Dr. Peterson and Radiology Regional Center”

“We are pleased to take part in this important study evaluating potential new approaches to the early detection of breast cancer in women with dense breasts, which historically have been difficult to screen,” said Mary Kay Peterson, M.D., Director of Women’s Imaging at Radiology Regional Center and principal investigator for the SOMO•INSIGHT clinical study. “We strongly believe that early detection is critical and we are excited to be able to provide women in Southwest Florida with access to cutting edge technology that could potentially detect abnormalities earlier in the fight against breast cancer.”

The initiation of this multi-center 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 may have a higher risk of breast cancer. ABUS uses ultrasound (sound waves) at a safe frequency to create images of the breast tissue. Ultrasound may demonstrate cancer not visible with mammography in women who have dense breasts. U-Systems has developed the somo•v and is sponsoring the SOMO•INSIGHT clinical study to address the critical need of improved breast cancer detection in dense breasts.

“We are very excited to be initiating the SOMO·INSIGHT Clinical Study with Dr. Peterson and Radiology Regional Center,” said Ron Ho, president and CEO of U-Systems. “The use of the somo•v™ ABUS in combination with mammography may aid the physician in earlier detection of breast cancer for a large group of asymptomatic women with increased breast density. We believe that somo•v ABUS technology will play a vital role in significantly advancing breast cancer screening and ultimately save lives.”

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 Radiology Regional Center

Radiology Regional Center is a premier diagnostic facility founded on the principles of providing state-of the-art technology in a warm, comfortable environment. A physician-owned and managed practice, our commitment is to maintain highly skilled staff and provide the highest quality health care to our community. For over 35 years, we have expanded our scope of services and number of outpatient facilities to meet the growing needs of our patients and referring physicians.