Given Imaging envisions FDA sign-off by Q4 for PillCam Colon capsule

CEO Homi Shamir

Given Imaging ($GIVN) CEO Homi Shamir predicts an FDA regulatory sign-off for the company's new endoscopic pill camera by the start of the 2013 fourth quarter, made possible in part by promising new data from several European studies.

He told Bloomberg the results will help propel the company's PillCam Colon to the U.S. marketplace as early as the 2013 third quarter or by the beginning of Q4, wowing regulators with its "enormous" potential.

Given, which is based in Israel, already has a CE Mark for PillCam Colon, an 11 mm x 31 mm capsule with two tiny color video cameras on each end, a battery and an LED light source. After a patient swallows the device, it is designed to transmit images up to 35 frames per second for 10 hours. An FDA submission has remained pending since late November.

Shamir is bullish about Pillcam Colon's approval prospects based in part on results from those European trials, which the company detailed at the recent Digestive Disease Week conference in Orlando, FL. PillCam Colon, designed for use with patients who can't have a full colonoscopy, showed in one study of 100 patients that it was as good as CT-colonography in 98% of patients, but superior in that it detected more polyps. In another study, PillCam Colon was highly accurate in its detection of flat lesions, which have a higher cancer risk. A third study showed PillCam Colon carried a 95% sensitivity to detect colon inflammation and 100% specificity in accurately ruling it out, the company noted.

Shamir is already promoting PillCam Colon as a cost-saver. Bloomberg quotes him as saying the pricing would be similar to the company's long-selling PillCam SB, which costs about $500 per capsule, versus $800 to $1,2000 for the average colonoscopy. Something that is minimally invasive and cheaper but equal to or more effective than the existing standard of care has a great chance of gaining market traction.

- here's the Bloomberg story
- check out the data announcements

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