Given Imaging Initiates 800-Patient Multi-Center, Pivotal Trial for PillCam COLON 2

Given Imaging GIVN, a world leader in GI medical devices and pioneer of capsule endoscopy, today announced the initiation of and first PillCam COLON 2 capsule procedures in a large, multi-center, pivotal PillCam COLON 2 study, which will support the Company's planned 510(k) submission to the U.S. Food and Drug Administration. Seventeen sites will enroll a total of 800 patients, aged 50-75 years, who are at average risk for colonic polyps and comprise the normal screening population. "While colonoscopy remains the most effective test for colorectal cancer screening, not everyone is willing to undergo colonoscopy. Only half of eligible Americans have had a screening test(1), so we welcome additional tools that can help us increase compliance and lower the incidence of colorectal cancer," said Douglas Rex*, MD, Distinguished Professor of Medicine and Chancellor's Professor, Indiana University School of Medicine and Director of Endoscopy, Indiana University Hospital. "We recently completed a survey demonstrating that patients who are noncompliant with their physician's recommendation for a colonoscopy for colorectal cancer screening would prefer PillCam COLON capsule endoscopy over other screening modalities. Aspects of PillCam that are attractive include that it's less invasive, detects polyps better than some of the alternative tests and does not require either sedation or a driver to accompany the patient.