SenoRx Announces CE Mark Approval For Its SenoSonix With EnCor Breast Biopsy Ultrasound System

Aliso Viejo, CA - SenoRx, Inc. recently announced that it has received approval to apply the CE Mark to its SenoSonix with EnCor, an integration of its EnCor 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."

SOURCE: SenoRx, Inc.