Given Imaging Announces Several Studies Showing Clinical Efficacy of Capsule Endoscopy in Diagnosing and Managing Crohn's Disease

YOQNEAM, Israel - May 21, 2003 - Given Imaging (NASDAQ: GIVN) announced today that data from six studies presented at Digestive Disease Week 2003 in Orlando further support using capsule endoscopy for the diagnosis and evaluation of patients with suspected Crohn’s disease. These studies show that capsule endoscopy is a useful tool in the diagnosis of Crohn’s disease, avoids radiation associated with small bowel follow through procedures and provides a higher diagnostic yield.

Crohn's disease is a serious inflammatory condition of the gastrointestinal (GI) tract predominantly occurring in the small intestine. It is a chronic condition that historically has been difficult to diagnose as symptoms vary among patients. Until capsule endoscopy, physicians have used a variety of procedures for diagnosis including endoscopy and barium x-ray.

"Capsule endoscopy will play an important role in the diagnosis of Crohn’s disease. Capsule endoscopy may also play a role in the follow up of medically treated patients both in the numerous clinical trials underway as well as in daily clinical practice to determine mucosal healing. We’re learning from clinical trials that many patients with assumed active disease may in fact not have active inflammation as determined by objective measures. Capsule endoscopy findings in these patients may prove very valuable in guiding day to day therapy. It may also prove a very valuable tool in patients after surgery for Crohn’s disease as a predictive tool as to which patients require preventative medical therapy. Capsule endoscopy will also have a role in ruling out Crohn’s disease or other inflammatory lesions in a sub-set of IBS patients, one of the most common GI conditions," said Asher Kornbluth M.D., of The Henry D. Janowitz Division of Gastroenterology, Department of Medicine, The Mount Sinai Medical Center.

Studies presented at DDW related to the diagnosis of Crohn’s disease include:

• A 30 patient study by Dr. Alan Buchman, Dr. Frank Miller and Dr. Anita Wallin of Northwestern University to determine the accuracy of capsule endoscopy in the diagnosis of Crohn’s disease compared to small bowel follow through. The study concluded that capsule endoscopy and small bowel follow through are similarly useful in the diagnosis of Crohn’s disease, but clinically significant disease may be missed by small bowel follow through. In addition, capsule endoscopy is less invasive and less time-consuming for the patient than small bowel follow through and avoids radiation. Given that patients with clinically suspected Crohn’s disease recurrence may not have active Crohn’s, unnecessary and potentially harmful radiation can be avoided. Publishing ID S1355
   
• Dr. Simon K. Lo and a group of physicians from Cedars-Sinai Hospital in Los Angeles compared the efficacy of capsule endoscopy versus serology in the evaluation of Crohn’s disease. Physicians categorized 128 patients into three groups. In group A consisting of 44 patients with known Crohn’s disease, capsule endoscopy found small bowel findings in 80% of cases, and 52% had serologic data available for interpretation. Capsule endoscopy and serology had equal sensitivity in evaluating Crohn’s disease. Group B consisting of 44 patients with suspected Crohn’s disease had positive small bowel findings in 52% of cases and 36% had serologic data available for analysis. Capsule endoscopy and serology had equal sensitivities in detecting IBD, and capsule endoscopy was superior to Crohn’s disease-specific serology (50% vs. 19%). Group C consisting of 40 patients with other indications such as pain, gastrointestinal bleeding or incidental findings suspicious for IBD using capsule endoscopy. 88% of patients in this group had positive small bowel findings using capsule endoscopy but only 15% had available serologic data available for analysis. The study concluded that serology does not predict capsule findings in IBD. Capsule endoscopy and serology have equal sensitivity in evaluating for Crohn’s disease, but capsule endoscopy is superior to Crohn’s disease-specific serology in evaluating Crohn’s disease. Serology may be positive in patients with colonic lesions whereas capsule endoscopy is limited in this respect. Capsule endoscopy is positive in a majority of patients who present with known or suspected Crohn’s disease. Publishing ID M1889
   
• A team of physicians headed by Prof. Winfried Voderholzer, of Humboldt-Universität, Berlin, Germany are conducting an ongoing study using capsule endoscopy to evaluate whether small intestinal lesions heal under therapy. This study so far concludes that clinical improvement in Crohn’s disease goes along with improvement of sonographic findings rather than with mucosal healing, and that capsule endoscopy is a superior tool for diagnosing mucosal lesions in small intestinal Crohn’s disease. Publishing ID S1360.
   
• A 43 patient study by Dr. Miguel Mascarenhas-Saraiva and Dr. Luis M. Lopes, Hospital Da Trofa, Porto, Portugal studied the initial diagnosis and follow-up of patients suffering from Crohn’s disease. This study concluded that capsule endoscopy is a safe tool for diagnosing, and evaluating the extent and activity of Crohn’s disease. The study also found that it is useful for a differential diagnosis of indeterminate colitis. Capsule endoscopy may be the second-line investigation for small bowel Crohn’s disease after excluding stenosis by radiological investigation. Publishing ID M1888.
   
• A 16 patient study headed by Dr. Peter Bloom of Emory University, compared capsule endoscopy to conventional techniques including colonoscopy with ileoscopy and small bowel follow through for the evaluation of patients with known or suspected non-stricturing Crohn’s disease. Small intestine findings suggestive of Crohn’s disease were detected in 56% of patients using capsule endoscopy compared to 50% using ilesocopy and 19% of patients by small bowel follow through. Findings suggestive of Crohn’s disease proximal to the terminal ileum were detected in 44% of patients using capsule endoscopy compared to no lesions by the combination of ileoscopy and small bowel follow through. Capsule endoscopy provided additional information regarding the extent or absence of small intestinal disease proximal to the terminal ileum. The study concluded that capsule endoscopy appears to be a useful adjunctive tool for the confirmation and evaluation of the extent or exclusion of small intestine disease in patients with known or suspected non-stricturing Crohn’s disease. Publishing ID S1367.
   
• A team of physicians headed by Dr. Russell Heigh studied 8 patients with suspected Crohn’s disease. The study concluded that capsule endoscopy and CT Enterography are comparable and significantly better than small bowel follow through for the diagnosis of non-obstructing Crohn’s disease. In patients with suspected small bowel Crohn’s disease, both capsule endoscopy and CT Enterography detect additional findings. Capsule endoscopy was found to be more accurate in detecting mucosal pathology, while CT Enterography may be considered in patients with suspected non-obstructive small bowel Crohn’s disease and normal small bowel follow through, recognizing that even when small bowel follow through is normal a stricture may be identified, resulting in an impacted capsule. Publishing ID 285.
   

About DDW
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 (AASLD), the American Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 17-22, 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.

About Given Imaging
Given Imaging develops, produces and markets the Given® Diagnostic System featuring the M2A(R) Capsule Endoscope, the only non-invasive method for direct visualization of the entire small intestine. The system uses a disposable miniature video camera contained in a capsule which is ingested by the patient. The M2A capsule passes naturally through the digestive tract, transmitting high quality color images, without interfering with the patient's normal activities. The system received clearance from the FDA in August 2001 and received permission to affix the CE mark in May 2001. Distribution channels for the system have been established in more than 50 countries worldwide. The M2A has been utilized to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease and other malabsorption disorders, benign and malignant tumors of the small intestine, vascular disorders, medication related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit www.givenimaging.com.

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19.Sept.'03