SOURCE: Given Imaging

May 18, 2008 15:00 ET

Investigators Suggest PillCam® SB as First-Line Diagnostic Tool for High Risk Celiac Disease Patients

Study Shows PillCam SB Provides Well Defined Visualization of the Villous Pattern and Proves Accurate in Identifying Celiac Markers

YOQNEAM, ISRAEL and SAN DIEGO, CA--(Marketwire - May 18, 2008) - Given Imaging Ltd. (NASDAQ: GIVN) today announced a study presented at the Digestive Disease Week® (DDW) 2008 conference this week determined that capsule endoscopy is a non-invasive, patient-friendly tool that provides good quality images of the small bowel mucosa and enables physicians to identify endoscopic markers of celiac disease (CD) as accurately as standard endoscopy. Led by Cristiano Spada, MD, Digestive Endoscopic Unit of the Catholic University in Rome, study investigators suggest PillCam SB as a first-line diagnostic tool in high risk CD patients.

"Capsule endoscopy with PillCam SB provides clear visualization of the villous patterns and accurately records endoscopic markers associated with celiac disease. This patient-friendly option is of particular relevance to high-risk patients and should be considered as a first-line diagnostic tool," said Dr. Spada.

The aim of the study was to evaluate if capsule endoscopy could play a role in the diagnosis of CD and serve as an alternative method for villous atrophy evaluation. Both esophagogastroduodenoscopy (EGD) and capsule endoscopy with PillCam SB showed the presence of at least one endoscopic marker in 31 out of 42 patients. PillCam SB identified thirty-eight (38/42) patients with villous atrophy and also found endoscopic markers of CD in 22/24 (91.6%) of Marsh III patients. The Marsh classification is a methodology for describing the changes which affect the villi of the small intestine when affected by CD. Marsh scores range from 0 (normal mucosa) to IV (hypoplasia of the small bowel). Marsh III indicates partial or complete villous atrophy. Both EGD and PillCam SB capsule endoscopy showed normal results in the remaining patients. Thirty-one (31) patients had mucosal changes beyond the proximal jejunum, and 2 patients had an extension up to the ileum.

The 42-patient study used EGD and PillCam capsule endoscopy of the small bowel to evaluate patients with positive serology studies prospectively. Capsule endoscopy findings were evaluated for the presence of endoscopic markers suggestive of CD, such as scalloping, nodular mucosa, reduction of duodenal folds or a mosaic pattern and villous atrophy.

This study confirms the current ICCE guidelines and the growing body of clinical evidence that supports the use of CE to diagnose and screen patients who are sero-positive for CD. The ICCE guidelines also recommend CE use in patients who are symptomatic on a gluten-free diet. Capsule endoscopy is especially indicated as an adjunctive method for patients presenting with alarm symptoms such as weight loss, fever and pain (1).

About Digestive Disease Week

DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy and the Society for Surgery of the Alimentary Tract, DDW takes place May 17-22, 2008, at the San Diego Convention Center, San Diego, CA. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit www.ddw.org.

About Given Imaging Ltd.

Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company's technology platform is the PillCam® Platform, featuring the PillCam video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient, a sensor array, data recorder and RAPID® software. Given Imaging has a number of available capsules: the PillCam SB video capsule to visualize the entire small intestine which is currently marketed in the United States and in more than 60 other countries; the PillCam ESO video capsule to visualize the esophagus; the Agile™ patency capsule to determine the free passage of the PillCam capsule in the GI tract and the PillCam COLON video capsule to visualize the colon that has been cleared for marketing in the European Union. PillCam COLON has received a CE Mark, but is not cleared for marketing or available for commercial distribution in the USA. More than 700,000 patients worldwide have benefited from the PillCam capsule endoscopy procedure. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel. It has operating subsidiary companies in the United States, Germany, France, Japan, Australia and Singapore. Given Imaging's largest shareholders include Elron Electronic Industries (NASDAQ & TASE: ELRN). For more information, visit http://www.givenimaging.com.

This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, projections about our business and our future revenues, expenses and profitability. Forward-looking statements may be, but are not necessarily, identified by the use of forward-looking terminology such as "may," "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual events, results, performance, circumstances or achievements of the Company to be materially different from any future events, results, performance, circumstances or achievements expressed or implied by such forward-looking statements. Factors that could cause actual events, results, performance, circumstances or achievements to differ from such forward-looking statements include, but are not limited to, the following: (1) satisfactory results of clinical trials with PillCam COLON (2) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (3) our success in implementing our sales, marketing and manufacturing plans, (4) protection and validity of patents and other intellectual property rights, (5) the impact of currency exchange rates, (6) the effect of competition by other companies, (7) the outcome of future litigation, including patent litigation with Olympus Corporation, (8) our ability to obtain reimbursement for our product from government and commercial payors, (9) quarterly variations in operating results, (10) the possibility of armed conflict or civil or military unrest in Israel, and (11) other risks and factors disclosed in our filings with the U.S. Securities and Exchange Commission, including, but not limited to, risks and factors identified under such headings as "Risk Factors," "Cautionary Language Regarding Forward-Looking Statements" and "Operating Results and Financial Review and Prospects" in the Company's Annual Report on Form 20-F for the year ended December 31, 2007. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Except for the Company's ongoing obligations to disclose material information under the applicable securities laws, it undertakes no obligation to release publicly any revisions to any forward-looking statements, to report events or to report the occurrence of unanticipated events.

(1) Mergener, Literature Review and Recommendations For Clinical Application of Small Bowel Capsule Endoscopy Based on a Panel of International Experts: Endoscopy, Vol.39, October 2007

Contact Information