Is the colon opportunity for Given Imaging more a hope than reality? Will the improved Colon2 capsule be the key? Is the sensitivity at higher levels deemed more clinically useful and more competitive to traditional colonoscopy?
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Shares of Given Imaging Ltd. slumped Tuesday after the company received a not substantially equivalent (NSE) letter from the Food and Drug Administration regarding its application to market PillCam Colon in the U.S.
Shares of the wireless imaging systems company dropped nearly 17% to $12.88, it’s lowest since Oct. 31, 2003…
The FDA’s decision isn’t expected to have material impact on Given Imaging ’s (nasdaq: GIVN - news - people) fiscal 2008 revenue since PillCam Colon sales in the U.S. weren’t expected to be significant.
PillCam Colon is an ingestible video capsule featuring a disposable, miniature video camera used to detect gastrointestinal disorders. It was recently launched in Europe and other countries.
Given Imaging, based in Yoqneam, Israel, will report fourth-quarter and fiscal 2007 results and provide fiscal 2008 guidance after market’s close on Feb. 20.
Oppenheimer analyst Amit Hazan expects fourth-quarter results to be in-line or slightly above his earnings estimate of 12 cents a share and sales of $31.1 million.
He lowered his fiscal 2008 estimates to remove U.S. PillCam Colon sales, now expecting earnings of 43 cents from 44 cents and sales of $127.8 million from $129.8 million…
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