ALISO VIEJO, Calif., April 10, 2008 (PRIME NEWSWIRE) -- SenoRx, Inc. (Nasdaq:SENO) today announced that it has received approval to apply the CE Mark to its SenoSonix(tm) with EnCor, 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. The CE Mark is required for sales in countries within the European Economic Community. SenoRx and Ultrasonix had previously announced the receipt of 510(k) clearance in the United States for the SenoSonix system in October 2007.
Launching its EnCor system in November 2005, SenoRx currently has an installed base of more than 500 of its breast biopsy systems in the United States and Canada. SenoRx began launching the EnCor system in Europe during the fourth quarter of 2007. Ultrasonix launched its innovative Sonix series of Smart Ultrasound systems in 2005 and has placed over 1,000 systems worldwide.
"Having the right to apply the CE Mark to the SenoSonix system further strengthens our EnCor product platform. While we are positioning SenoSonix with EnCor to compete in the breast surgeon's office in the United States, we also believe that the value and convenience proposition for this product may also be compelling in markets outside the U.S. where a significant percentage of biopsy procedures utilize ultrasound imaging. We believe that the SenoSonix system may 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," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "Full commercial launch of the product began in the U.S. in February 2008 and will be launched in April in select European Economic Community countries."
About SenoRx
SenoRx (Nasdaq:SENO) develops, manufactures and sells minimally invasive medical devices used by breast care specialists for the diagnosis and treatment of breast cancer, including its flagship EnCor(r) system and Contura(tm) MLB. SenoRx's field sales organization serves over 1,000 breast diagnostic and treatment centers in the United States and Canada. The company's line of breast care products includes biopsy disposables, biopsy capital equipment, diagnostic adjunct products and therapeutic disposables. SenoRx is developing additional minimally invasive products for the 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 SenoSonix with EnCor, including the ability to competitively position it in the physician office and other markets, its expected value proposition and convenience in markets, including outside the United States, its cost-effectiveness and its 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 most recent annual report on Form 10-K for the year ended December 31, 2007, 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.