Given Imaging Ltd., based in Yokneam, announced on Monday that it has obtained the CE mark for the sale of PillCam COLON 2 in Europe.

Given Imaging announced encouraging results from a trial that validated new features of the company's second-generation PillCam(R) Colon video capsule and system.

"The main purpose of the trial was to evaluate the performance of new technologies embedded in the new capsule and PillCam platform. The results of this feasibility trial confirm the functionality of the system and give us increased confidence about the potential of PillCam COLON 2 as a useful tool for visualizing pathology in the colon. Despite statistical limitations resulting from the size of the trial and the relatively low prevalence of polyps, we are very pleased with the high degree of consistency in the sensitivity and specificity of the data, both of which were high and balanced," said Homi Shamir, CEO and President of Given Imaging Ltd. "We are now initiating additional multicenter clinical trials in Europe and Israel and intend to complete these trials over the next few months. Subsequently, we will begin a phased roll out of PillCam COLON 2 in Europe and a few other countries outside of the U.S. in 2010. On a parallel track, we have initiated pre-registration studies in the United States with leading key opinion leaders to prepare for a subsequent FDA pivotal trial."

PillCam COLON currently is not available for sale in the United States.

Conducted by clinicians at five hospitals in Israel, the study evaluated the performance of PillCam COLON 2 in 98 patients who had risk or warning symptoms of colon pathology. Like other PillCam capsules in Given Imaging's suite of products, PillCam COLON 2 does not require the use of sedation, intubation or air insufflation during the procedure. The Company intends to reveal PillCam COLON 2 in Europe at the Gastro 2009 conference this fall at which time it will disclose additional details, including product specifications and software enhancements.

Colon cancer involves the large intestine (colon), the lower part of the digestive tract, while rectal cancer involves the last 6 inches of the colon. Together, they're often referred to as colorectal cancers. Colon and rectal cancers begin in the digestive tract and occur when cells that line the colon or the rectum become abnormal and grow out of control. About 147,000 people in the U.S. are diagnosed with colorectal cancer annually, according to the National Cancer Institute.

PillCam COLON enables the physician to directly see the colon mucosa in its natural state while not requiring sedation, intubation, air insufflation, hospitalization or radiation. PillCam COLON is a smooth plastic capsule which can be naturally ingested with a sip of water. It utilizes advanced optical technology with tiny video cameras at each end, which produces enhanced resolution images and includes automatic light control and a wide field of view.

Given Imaging has advanced gastrointestinal diagnosis by developing innovative, patient-friendly tools based on its PillCam(R) Platform. PillCam capsule endoscopy provides physicians with natural images of the small intestine via PillCam(R) SB, the esophagus through PillCam(R) ESO, and the colon with PillCam(R) COLON [PillCam COLON is not cleared for use in the USA]. The PillCam capsules are miniature video cameras that patients ingest. Given Imaging's other capsule products include Agile(TM) patency capsule, to verify intestinal patency, and Bravo(R), the only wireless, catheter-free, 48-hour pH test commercially available for pH testing to assess gastroesophageal reflux disease (GERD).

Given Imaging's products use cutting-edge, wireless technology and advanced software to enable gastroenterologists to better diagnose disease of the esophagus, small bowel and colon and more accurately treat patients. All Given Imaging products allow patients to maintain normal activities. Since 2001, more than one million PillCam(R) video capsules have helped physicians evaluate patients for GI disorders. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia and Singapore.