SUNNYVALE, Calif., May 14, 2012 (BUSINESS WIRE) —
      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(R) 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,” 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

      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(TM)
      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.

      About U-Systems

      As the leader in automated breast ultrasound technology U-Systems is
      establishing the standard for breast ultrasound screening. The
      U-Systems’ somo*v Automated Breast Ultrasound (ABUS) system and
      somo*VIEWer Advanced 3D Workstation are cleared under 510(k) for
      diagnostic use as an adjunct to mammography. For more information about
      U-Systems, please visit our website at
      https://www.u-systems.com .

      A broadcast Broll package is available in HD Quicktime file format. The
      Broll package was released after the FDA Panel Vote on April 11, 2012

      SOURCE: U-Systems

              for U-Systems 
              Chris K. Joseph, 510-435-4031 

      Copyright Business Wire 2012