Given Imaging Ltd. Announces New Study Shows Impact of PillCam(R) SB on Management of Symptomatic IBD Cases

YOQNEAM, ISRAEL--(Marketwire - October 18, 2011) - Given Imaging Ltd. (NASDAQ: GIVN), a world leader in GI medical devices and pioneer of capsule endoscopy, today announced that results of a study published in the September issue of Inflammatory Bowel Disease showed that physicians changed how they treated the majority of their symptomatic IBD cases, after performing PillCam capsule endoscopy. The authors found that among the patients in the study with Crohn’s disease, 61.6 percent of them had their medications changed within three months of receiving PillCam capsule endoscopy. The study was led by Millie D. Long, MD, MPH, of the University of North Carolina at Chapel Hill*.

“This study retrospectively investigated the use of capsule endoscopy in a population of patients with previously diagnosed inflammatory bowel disease,” said Millie D. Long, MD, MPH, Assistant Professor of Medicine, University of North Carolina at Chapel Hill. “Our results suggest that capsule endoscopy assists physicians in making management decisions in symptomatic patients with Crohn’s disease, indeterminate colitis, and pouchitis.”

The retrospective cohort study included 124 PillCam capsule endoscopy procedures performed for the indication of symptomatic inflammatory bowel disease from July 2003 through December 2009 at the University of North Carolina Hospitals. There were high rates of IBD-specific medication changes within 3 months following the PillCam capsule endoscopies:

• 61.6 percent of patients with Crohn’s disease had a change in medication management
• 39.5 percent of patients with Crohn’s disease had a new IBD medication initiated
• 66.7 percent of indeterminate colitis patients had a change in medication management
• 40.0 percent of indeterminate colitis patients had a new IBD-specific medication initiated

The specific findings on PillCam capsule endoscopy also influenced medical management. Severe findings on capsule endoscopy in patients with Crohn’s disease, as compared to no/minimal findings, resulted in significant differences in medication changes (73.2% versus 51.1%, P = 0.04), addition of medications (58.5% versus 22.2%, P < 0.01), and surgeries (21.9% versus 4.4%, P = 0.01).

“This study adds to the large body of clinical evidence supporting the updated FDA clearance for PillCam SB to detect and monitor lesions that may indicate Crohn’s disease,” said Homi Shamir, president and CEO of Given Imaging Ltd. “PillCam SB is proven to be a valuable tool for disease detection and monitoring in patients suffering from Crohn’s disease and other small bowel conditions, and we are pleased to see that PillCam SB is playing an important role in helping physicians to better manage their patients with Crohn’s disease by helping to guide medication management.”

In March 2011, Given Imaging announced updated clearance from the U.S. Food and Drug Administration (FDA) for the PillCam SB® video capsule, including clearance to promote its use in detection and monitoring of lesions that may indicate Crohn’s disease.

*The study was supported in part by grants from the National Institutes of Health, a junior faculty career development award, and a senior research award from the Crohn’s and Colitis Foundation of America.

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