GIVN Given Imaging Ltd. - Ordinary Shares (MM)

Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced three new studies underscoring the value of PillCam SB in detecting and evaluating Crohn's lesions in the small bowel. The studies were presented at the United European Gastroenterology Week (UEGW), Europe's largest gastroenterology conference, being held in Stockholm, Sweden from October 22nd through October 26th. Given Imaging is exhibiting at booth A08:30 throughout the conference.

"Using capsule endoscopy with appropriate patients who have clinically suspected Crohn's disease can help physicians reach a definitive diagnosis sooner, which may lead to improved patient management and symptom relief," said Ervin Toth, MD, Endoscopy Unit, Skane University Hospital, Lund University, Malmö, Sweden. "The results of our study suggest that physicians should consider incorporating capsule endoscopy earlier into the diagnostic work-up of patients with suspected Crohn's disease."

In a new study (abstract P1442) titled, "Capsule Endoscopy is Superior to Magnetic Resonance Enterography for Detection of Crohn's Lesions in the Small Bowel," researchers from Skane University Hospital at Lund University in Malmö, Sweden, retrospectively compared capsule endoscopy and MRE for diagnostic utility in definitively diagnosing Crohn's disease among patients in whom Crohn's was clinically suspected. Of the 115 patients evaluated, 33 percent exhibited lesions consistent with Crohn's. In more than half (52%, 17/33) of the patients definitively diagnosed with Crohn's, their MRE findings were negative, and capsule endoscopy revealed larger extension of Crohn's compared to MRE in four additional patients. The study authors concluded that a large proportion of mucosal lesions that could indicate the presence of small bowel Crohn's disease are not detected by MRE. In addition, using MRE alone to manage patients may lead to inadequate therapeutic treatment strategies.

A second study (abstract P0121) titled, "Role of capsule endoscopy in the evaluation of different segments of the small bowel in Crohn's disease: Correlation of biomarkers, endoscopy, and Lewis Score," Portuguese researchers from Hospital Sao Joao Porto in Porto, Centro Hospitalar do Alto Ave in Guimaraes and University of Porto in Porto evaluated the correlation of biomarkers and endoscopy with the Lewis score (LS) in each third of the small bowel, demarcated by transit time in 87 patients. Researchers found that 28 percent of patients had high degree of correlation in the first two thirds of the small bowel rating the LS greater than 135. There were additional correlations found between LS and biomarkers including sideropenia, total serum protein, serum albumin and c-reactive protein levels and platelet counts. In the third segment of the small bowel, investigators detected significant correlations between LS and hemoglobin levels and thrombocytosis in addition to other biomarkers involved in the first two tertile segments. Researchers concluded that there is a correlation among upper digestive tract disease, biomarkers and endoscopic findings, underlining the importance of capsule endoscopy in Crohn's disease.

A third study (abstract P0110) titled, "Clinical outcome and management of small bowel video capsule retention in a single-center 10-year experience of 2,409 procedures," concluded that capsule retention is a rare complication and in most cases can be managed electively with non-surgical intervention. Researchers at Skane University Hospital of Lund University in Malmö, Sweden, reviewed the medical records of 2,409 consecutive patients who had undergone capsule endoscopy procedures between 2001 and 2011. One percent (25/2409) of patients retained capsule, including 11 patients who had undergone previous abdominal surgery. Emergency intervention was required in just four cases, three of which were managed endoscopically and one of which was managed surgically. Non-emergency cases were managed endoscopically in eight cases and surgically in 7 cases. Three capsules dislodged after steroid treatment and three cases resolved without intervention.

About Crohn's Disease Crohn's disease is a chronic condition that causes inflammation in the lining of the small intestine wall and can affect any part of the digestive tract. Symptoms can include diarrhea, abdominal pain, weight loss and rectal bleeding. Roughly 50 percent of all cases of Crohn's disease are diagnosed in the last part of the small intestine (the terminal ileum) and cecum. This area is also known as the ileocecal region. Other cases of Crohn's may affect one or more of the following: the colon only, the small bowel only (duodenum, jejunum and/or ileum), the stomach or esophagus.(1) Roughly 500,000 Americans suffer from Crohn's disease, and about 20 percent have a direct relative with some form of inflammatory bowel disease (IBD).(2) It affects men and women equally. The cause is unknown, but the most popular theory is that the immune system is reacting to a virus or bacterium that causes inflammation.(3) Depending on the severity, treatment options include nutritional supplements, drugs and surgery. There is currently no cure for the disease.(4)

About PillCam SB The PillCam® SB video capsule measures 11 mm x 26 mm and weighs less than four grams. Now in its second generation, PillCam SB 2 contains an imaging device and light source and transmits images at a rate of two images per second generating more than 50,000 pictures during the course of the procedure. Initially cleared by the U.S. Food and Drug Administration in 2001, PillCam SB is clinically validated by more than 1,500 peer-reviewed studies. It is an accurate, patient-friendly tool used in patients two years and older by physicians to visualize the small bowel. PillCam SB is the gold standard in small bowel evaluation.

The risks of PillCam® capsule endoscopy include capsule retention, aspiration, or skin irritation. The risks of the Agile™ GI patency test include capsule retention and aspiration. Endoscopic placement may present additional risks. Medical, endoscopic, or surgical intervention may be necessary to address any of these complications, should they occur.

About Given Imaging Ltd. Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® video capsules for the small bowel, esophagus and colon [PillCam® COLON not approved for use in the United States.], industry-leading ManoScan™ high-resolution manometry and Bravo® wireless and Digitrapper® pH and impedance products. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam and Hong Kong. For more information, please visit www.givenimaging.com.

Forward-Looking Statements 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) our ability to develop and bring to market new products, (2) our ability to successfully complete any necessary or required clinical studies with our products, (3) our ability to receive regulatory clearance or approval to market our products or changes in regulatory environment, (4) our success in implementing our sales, marketing and manufacturing plans, (5) the level of adoption of our products by medical practitioners, (6) the emergence of other products that may make our products obsolete, (7) lack of an appropriate bowel preparation materials to be used with our PillCam COLON capsule, (8) protection and validity of patents and other intellectual property rights, (9) the impact of currency exchange rates, (10) the effect of competition by other companies, (11) the outcome of significant litigation, (12) our ability to obtain reimbursement for our product from government and commercial payors, (13) quarterly variations in operating results, (14) the possibility of armed conflict or civil or military unrest in Israel, (15) the impact of global economic conditions, (16) our ability to successfully integrate acquired businesses, (17) changes and reforms in applicable healthcare laws and regulations, (18) product quality issues that could require us to recall products and impact our sales, and (19) 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, 2010. 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) qurlyjoe.bu.edu/cduchome.html Inflammatory Bowel Disease Frequently Asked Questions. (2) Crohn's and Colitis Foundation of America (ccfa.org) (3) National Institute of Diabetes and Digestive and Kidney Diseases (niddk.nih.gov) (4) http://www.nhlbi.nih.gov/health/dci/Diseases/ida/ida_causes.html

For further information contact: Fern Lazar/David Carey Lazar Partners Ltd. 1-212-867-1768 flazar@lazarpartners.com dcarey@lazarpartners.com