Given Imaging introduces new PillCam system at GASTRO 2009 Conference

Nov 23 2009

Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule endoscopy, today announced the launch of its second-generation PillCam® COLON capsule at the Gastro 2009 Conference taking place in London. Like Given Imaging's other capsule endoscopes, PillCam® SB and PillCam® ESO, PillCam COLON could be a more patient-friendly tool for imaging the gastrointestinal tract.

This advanced PillCam system contains proprietary, innovative technologies, including intelligent functionality and superior imaging, designed to provide physicians with clear and precise views of the colon and polyps of interest. Following receipt of the CE mark in September 2009, Given Imaging will start marketing PillCam® COLON 2 in select European countries with availability throughout Europe expected by mid-2010.

The Company also announced that independent investigators presented results of a 98-patient feasibility study. The investigators concluded that PillCam COLON 2 is a safe and effective method to visualize the colon and detect colonic polyps. An article discussing the study has been accepted for the December 2009 edition of the journal Endoscopy.

High Sensitivity and Specificity

Results of the study comparing PillCam COLON 2 to colonoscopy, showed a sensitivity of 89 percent and a specificity of 76 percent in detecting polyps greater than or equal to 6 mm and a sensitivity of 88 percent and a specificity of 89 percent in detecting polyps greater than or equal to 10 mm. Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risks or warning symptoms of colon pathology. Like Given Imaging's other PillCam capsules, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure, offering physicians and patients a convenient way to visualize the colon.

"The data for PillCam COLON 2 are promising and suggest it may be a safe, minimally invasive option for visualizing the colon in patients who are unwilling to undergo colonoscopy, have undergone an incomplete examination, or those for whom colonoscopy is contraindicated. We are encouraged by the data, which suggest that PillCam COLON 2 could be a reliable alternative to conventional colonoscopy for these types of patients," said Prof. Rami Eliakim, Chairman of Medicine and Director of the Department of Gastroenterology, Rambam Health Care Campus, Haifa, Israel.

New Features of PillCam COLON 2

Breakthrough technology offered in PillCam COLON 2 and the PillCam Platform enables a more patient-friendly option for visualizing the colon. New features include:

Intelligent Functionality

Bi-directional communication between PillCam Colon 2 and the DataRecorder enables tracking of the capsule's motion in the GI tract so that the image capture rate can be adjusted to maximize colon tissue coverage.

-- Adaptive Frame Rate adjusts the image capture rate from four frames per second to 35 frames per second, enabling creation of a smooth, continuous video. -- Polyp Size Estimation is a new research tool that allows clinicians to estimate the size of polyps.

Superior Imaging Compared to COLON 1

-- Advanced optics for enhanced image quality and polyp detection. -- 172° field of view from each imager offers a near 360° view of the colon.

Additionally, Given Imaging has incorporated other features into the RAPID® software to further streamline office workflow.

"PillCam COLON 2 incorporates the cumulative expertise gained from the first PillCam COLON as well as more than 1,000,000 PillCam® capsule ingestions worldwide," said Homi Shamir, president and CEO of Given Imaging. "Despite the small size of this initial study and the relatively low prevalence of polyps, we are very encouraged by this data and look forward to working with leading gastroenterologists in Europe, the United States and other markets to initiate additional clinical trials."

PillCam COLON 2 will be supported by the PillCam Platform with RAPID C2, based upon RAPID 6 software.

Conference Call and Webcast Details

Given Imaging will host a conference call and meeting today with members of the financial community to discuss new features of the company's second-generation PillCam COLON and review results from the recently completed Israeli feasibility study. The meeting will take place at the Novotel London ExCel Hotel, Western Gateway, Royal Victoria Dock, E16 1AA, London, UK and will begin at 9:00 am New York Time, 2:00 pm London Time. The meeting will take place in the King George V Room.

SOURCE: Given Imaging