Data on Given Imaging's Pillcam(TM) Video Capsule to be Highlighted at American College of Gastroenterology Annual Meeting -- Clinical Trial Results From the Recently-Cleared Esophageal Video Capsule to be Presented -- YOQNEAM, Israel, Oct. 27 /PRNewswire-FirstCall/ -- Given Imaging (NASDAQ: GIVN) today announced that data from more than 35 studies featuring the PillCam(TM) Video Capsule will be presented at the Annual Meeting of the American College of Gastroenterology (ACG). The conference will take place October 29 - November 3 in Orlando, Florida. Given Imaging will host booth #1729 at the conference. "We look forward to the presentation of compelling clinical data, including data from the PillCam ESO pivotal clinical trial which demonstrate it to be an effective tool for visualizing esophageal disorders," said Gavriel D. Meron, president and chief executive officer of Given Imaging. "Studies presented at this year's ACG provide additional evidence for using PillCam(TM) SB endoscopy as a diagnostic tool of choice for expanded indications such as suspected and established Crohn's disease and small bowel tumors." * ESO Clinical Trial Results ACG scientific highlights will include final results from a 106-patient clinical study comparing the diagnostic utility of Given Imaging's newest capsule endoscope -- PillCam(TM) ESO for imaging of the esophagus compared to traditional endoscopy. These results will be presented in an abstract entitled, "M2A Esophageal Capsule Endoscopy (ECE) is comparable to Traditional Upper Endoscopy (EGD) in Detection of Esophagitis and Barrett's Esophagus in Patients with GERD symptoms," (Abstract #129 on Monday, November 1). PillCam ESO (four frame version) was cleared by the U.S. Food and Drug Administration (FDA) on October 25. PillCam(TM) ESO will be marketed through an alliance with the InScope division of Ethicon Endo-Surgery. The alliance was announced in May 2004 and specified that Given Imaging would retain responsibility for regulatory approval, manufacturing, order invoicing and processing, collections, technical support and on-site system service, while InScope would be responsible for sales, marketing and promotion, as well as efforts to establish reimbursement policies for PillCam ESO. * Launch of Advanced Software At ACG, Given will also unveil its most advanced software for the Given Diagnostic System designed to make the overall system easier to use through enhancements including improved reading efficiency and easier reporting capabilities. New features include a Suspected Blood Indictor (SBI) that automatically detects areas of potential GI bleeding, a new tissue color bar feature that facilitates the pre-reading and reviewing process, multiple viewing options and advanced reporting capabilities including a predefined and customized dictionary. In addition, full screen imaging and image zoom are now available. The scientific agenda at ACG will also include new clinical data showing the utility of PillCam capsule endoscopy in: Crohn's Disease * Retrospective Experience with Capsule Endoscopy (CE) in Crohn's Disease (CD). Abstract 949. Conclusion: Capsule endoscopy (CE) may play an important adjunctive role in the diagnosis of small bowel Crohn's disease, since SB disease may be seen in a substantial minority of pts despite a negative conventional evaluation in this limited experience. Small bowel imaging should recede CE to exclude strictures. Retained capsules are not uncommon, but appeared to be symptomatic in this small study. Larger prospective studies of CE in CD are needed. (Monday, November 1) * A Meta-analysis of Capsule Endoscopy Compared to Other Modalities in Patients with Non-stricturing Small Bowel Crohn's Disease. Abstract 479. Conclusion: In patients with suspected or established non-stricturing small bowel Crohn's disease, capsule endoscopy may be the test of choice for initial diagnosis. (Monday, November 1). * Incidence and Outcome of the Retained Video Capsule Endoscope (CE) In Crohn's Disease (CD): Is it a "Therapeutic Complication?" Abstract 734. (Monday, November 1). Conclusion: Capsule endoscopy can be used safely in patients with either suspected or established Crohn's disease. (Monday, November 1). Small Bowel Tumors * Small Bowel Tumors detected by M2A(R) Capsule Endoscopy. Abstract 532. Conclusion: M2A(R) capsule endoscopy is the diagnostic procedure of choice for diagnosis of small bowel tumors. (Sunday, October 31) * The Use of Capsule Endoscopy Surveillance in Individuals with the Hereditary Colorectal Cancer Syndromes. Abstract 945. Conclusion: SB polyps are surprisingly common in FAP but their importance is currently unknown. CE should be performed in FAP patients with stage III and IV duodenal polyposis. Clinically significant polyps are detected on CE in asymptomatic PJS patients and led to an operation in 40% of PJS subjects. CE surveillance should be the method of biennial SB surveillance for PJS patients. CE is safe in polyposis patients. (Tuesday, November 2). * Localizing the Lesion by Capsule Endoscopy: Newer Techniques in Improving Accuracy. Abstract 931. Conclusion: Localization software is a useful adjunct in determining the site of a lesion in the small intestine. Further developments in the software technology are likely to improve the accuracy for localizing lesions seen by capsule endoscopy. (Sunday, October 31) * Obscure Gastrointestinal Bleed in Elderly Woman with Small Bowel Leiomyoma Diagnosed by Capsule Endoscopy. Abstract 318. (Sunday, October 31). * Capsule Endoscopic Diagnosis of a Localized Small Bowel Cancer Missed by Enteroclysis in a Patient with HNPCC. Abstract 402. Conclusion: CE should be done to evaluate small bowel disease in the high risk group for adenocarcinoma event if the enteroclysis is normal. (Sunday, October 31). * Small Intestine Adenocarcinoma in Celiac Disease: A Role for Capsule Endoscopy? Abstract 792. (Sunday, October 31). * Diagnosis of Malignant Hemangioendothelioma, Capsule Endoscopy, Occult GI Bleeding. Abstract 1019. (Sunday, October 31). Patients Outcomes and Management * The Spectrum of Inflammatory Changes Involving the Small Intestine as Seen on Wireless Capsule Endoscopy: 18-Month Experience in Private GI Practice. Abstract 744. Conclusion: Wireless capsule endoscopy should improve our understanding of the natural history of inflammatory bowel diseases. * Wireless Capsule Endoscopy in Clinical Practice: 18-Month Experience in a Private GI Practice, Brooklyn, N.Y., USA. Abstract 762. Conclusion: In comparing wireless capsule endoscopy (WCE) in clinical practice to large clinical trials, WCE maintained a high diagnostic yield in clinical practice. WCE was practical, and led to significant therapeutic gain. (Sunday, October 31). * Does Capsule Endoscopy Make a Difference in the Management of Patients with Occult GI Bleeding? Abstract 51. Conclusion: Capsule endoscopy seems to contribute positively to the management of patients with occult GI bleeding. (Tuesday, November 2). Pediatric Use * Ileoscopy with Videoscope in Pediatric-juvenile age. Abstract 643. Conclusion: The Pillcam(TM) Video Capsule is essential in the diagnosis and/or follow-up of chronic anemization, poliposis, and Inflammatory Bowel Disease also in a pediatric age. * The Utility of Wireless Capsule Endoscopy in the Evaluation of Suspected Crohn's Disease, Pediatric. Abstract 713. Conclusion: Wireless capsule endoscopy is effect in the identification of suspected small intestine Crohn's disease in children with undetected disease by conventional testing. For a full listing of data presentations featuring PillCam Video Endoscopes, please visit http://www.givenimaging.com/. Conference Call to Review Highlights Given Imaging will host a conference call on Wednesday, November 3 at 11:00 am Eastern Time to review PillCam Endoscopy highlights at ACG. Participating on the call will be Jamie S. Barkin, MD University of Miami and Mt. Sinai Medical Center and Glenn Eisen, MD, Associate Professor, Oregon Health and Science University Portland. The conference call will be webcast through the Company's website http://www.givenimaging.com/. About Given Imaging Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam Video Capsules for detecting disorders throughout the gastrointestinal tract. The company's technology platform is the Given(R) Diagnostic System, featuring the PillCam(TM) Video Capsule, a disposable, miniature video camera contained in a capsule which is ingested by the patient. The PillCam(TM)SB Video Capsule is the only naturally-ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 60 other countries and has benefited more than 122,000 patients worldwide. The PillCam(TM)ESO Video Capsule, for visual examination of the esophagus has been cleared by the FDA and a higher frame rate version will be commercialized pending FDA clearance. Capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Tokyo, Madrid and Sydney. For more information, visit http://www.givenimaging.com/. This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission. DATASOURCE: Given Imaging Inc. CONTACT: Carlo de la Mata of Given Imaging Inc., +1-770-662-0870; Fern Lazar, , or David Carey, , both of Lazar Partners Ltd., +1-866-GIVEN-IR, for Given Imaging Inc. Web site: http://www.givenimaging.com/

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