ALISO VIEJO, Calif., Oct. 17, 2007 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SenoSonix(tm) System, an integration of its EnCor(r) breast biopsy system with a state-of-the-art ultrasound imaging system. The device incorporates SenoRx's proprietary EnCor vacuum-assisted biopsy technologies with an ultrasound system developed and sold by Ultrasonix Medical Corporation of Canada. SenoRx and Ultrasonix have enjoyed a close working relationship, jointly developing the technology that facilitates the integration of the two products. The product will be branded SenoSonix(tm) and marketed as SenoSonix(tm) with EnCor Inside.
Ultrasonix launched its innovative Sonix series of Smart Ultrasound systems in 2005 and has placed over 1,000 systems worldwide. Launching its flagship EnCor system in November 2005, SenoRx currently has an installed base of more than 400 of its breast biopsy systems in the United States and Canada.
"We will position the SenoSonix device to compete in the physician's office segment for those surgeons performing vacuum-assisted biopsies in their office," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "We believe that the market segment is currently small, but growing rapidly. We further believe that the value and convenience proposition for this product may be compelling in markets outside the United States, which currently perform a significant percentage of biopsy procedures using ultrasound. The product is scheduled to be launched in the U.S. in January 2008. SenoSonix will be marketed and distributed by SenoRx while the parties work together to implement a full marketing and commercialization plan. We expect to receive the right to affix the CE Mark for the device in the European Economic Community (EEC) in the near-term."
"We believe that the SenoSonix system will uniquely address the breast biopsy market with a cost-effective solution that provides high-quality ultrasound imaging and guidance with vacuum-assisted breast biopsy capability in one device. The compact size and intuitive user interface of the SenoSonix system makes it attractive for the physician's office," said John Buhler, Ultrasonix Chief Executive Officer.
About SenoRx
SenoRx (Nasdaq:SENO), which completed its initial public offering of common stock in March 2007, develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis of breast cancer. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. With 18 products having received FDA 510(k) clearance across the continuum of breast care, SenoRx is developing additional minimally invasive products for diagnosis and treatment of breast cancer. For more information, visit the company's website at www.senorx.com.
The SenoRx, Inc. logo is available at http://www.primenewswire.com/newsroom/prs/?pkgid=3605
About Ultrasonix
Ultrasonix Medical is a privately held company based in Richmond, British Columbia, Canada focusing on development and manufacturing of high quality diagnostic ultrasound imaging systems. Ultrasonix brings "smart" ultrasound equipment and capabilities into private medical practices, clinics and hospitals alike. The company's award-winning devices incorporate high-quality imaging with unique workflow and data management features in an easy to use platform. Through its innovative products and features, Ultrasonix continues to deliver on its mission of providing better patient care making it a natural fit for the Breast Imaging market. Further information is available at www.ultrasonix.com
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Specifically, statements concerning SenoRx's ability to competitively position its SenoSonix product in physician's offices, the expected growth of such market segment, the expected value and convenience of this product, and the expected attractiveness to physicians are forward-looking statements within the meaning of the Safe Harbor. Forward-looking statements are based on management's current, preliminary expectations and are subject to risks and uncertainties, which may cause SenoRx's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect SenoRx's business and its financial results are detailed in its prospectus dated March 29, 2007 and its most recent quarterly report on Form 10-Q, in each case as filed with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, especially guidance on future financial performance, which speaks only as of the date they are made. SenoRx undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made, or to reflect the occurrence of unanticipated events.