Given Imaging ($GIVN) told investors this week that it will file two big regulatory submissions in the U.S. and Japan in the fourth quarter covering different iterations of its PillCam capsule.
Armed with data from the now-finished 885-patient PillCam COLON 2 trial, the Israeli company will seek FDA clearance for the product that visualizes the colon in patients who either can't have a colonoscopy or had incomplete ones. Keeping the timeframe will depend on upcoming meetings with FDA officials "in the near future" that "may impact our planned submission," the company warns in its 2012 second-quarter earnings announcement. Also on the company's plate: continued work to seek a U.S. screening indication for PillCam COLON 2, which first gained clearance in the European Union in September 2009.
In Japan, Given Imaging wants the PMDA to clear its PillCam Colon product to visualize the gastrointestinal mucosa to diagnose ailments in the colon. Plans call for using the recently completed, 72-patient PillCam COLON trial to back up the regulatory submission. The product first gained clearance in the European Union back in 2006, and Israel in February 2008, according to the company's website.
Both approvals could help Given Imaging access a $1.7 billion market covering 3.3 million annual procedures, the company estimates, with one-third of them in the U.S. and another third in Japan.
Given Imaging said it generated $44.5 million in revenue during its 2012 second quarter, essentially flat compared to the same period a year ago. Net income soared 59% to $3 million, or 10 cents per share, versus $1.9 million in the 2011 second quarter, or 6 cents per share a year ago. The company said its revenue in the Americas grew 6%, but dipped 9% in Europe, the Middle East and Africa, due in part to a weak Euro and lower PillCam sales in southern Europe. Similarly, revenues in the Asia-Pacific region declined 10%, year-over-year.
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