Given Imaging results
This article was originally published in The Gray Sheet
Executive Summary
Second quarter sales advanced 17% to $42.1 million, including $5.7 million from recently acquired Sierra Scientific Instruments, the firm reports Aug. 12. Given acquired the esophageal diagnostics marketer in March for $35 mil. (1"The Gray Sheet" March 29, 2010). Global sales of Given's PillCam SB 2 small bowel endoscopy capsules were flat, largely due to fewer procedures in the U.S. gastrointestinal market and economic instability in Europe, according to the company. As a result, the firm is now expecting full-year 2010 sales to be on the lower end of its previous $167 million-$174 million guidance. Given noted that it recently held a pre-IDE meeting with FDA regarding its PillCam COLON 2 clinical trial and that it is still planning to initiate a study in the second half of this year comparing the capsule-based system with standard colonoscopy. A 510(k) filing will follow in the second quarter of 2011, according to the company