Given Imaging Announces Study Concluding Capsule Endoscopy is the New Gold Standard for Detecting Small Bowel Crohn's Disease

Study shows M2A more sensitive than enteroclysis

YOQNEAM, Israel - June 17, 2003 - Given Imaging (NASDAQ: GIVN) announced today that a study published in the June issue of The American Journal of Gastroenterology (Volume 98, Issue 6) concludes that M2A capsule endoscopy is better than enteroclysis in diagnosing small bowel ulcers.

"The results of this study indicate that wireless capsule endoscopy is better than enteroclysis in the diagnosis of small bowel ulcers," said Douglas K. Rex, M.D., F.A.C.G., Professor of Medicine, Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, and President-elect of the American College of Gastroenterology (ACG). "Wireless capsule endoscopy is the new gold standard for detecting Crohn’s disease in the small bowel." Among the 40 patients studied using capsule endoscopy, 36 patients had indications for chronic iron deficiency anemia or gastrointestinal bleeding. Four patients had chronic abdominal pain with or without diarrhea and without evidence of bleeding. All patients had negative upper endoscopy and colonoscopy as well as small bowel barium studies prior to capsule endoscopy. Despite prior negative small bowel studies, three of the patients were identified with multiple small bowel ulcers following capsule endoscopy. Enteroclysis was performed on all three patients and the results were negative. All three patients were subsequently diagnosed with Crohn’s disease and all experienced clinical improvement following treatment.

"This study is yet another example of the clinical utility of M2A capsule endoscopy compared to traditional methods for diagnosing small bowel disorders," said Gavriel D. Meron, President and CEO of Given Imaging. "Crohn’s disease has historically been difficult to diagnose, and this study further supports existing studies that demonstrate that the M2A capsule is superior to traditional procedures for diagnosing this disease."

Enteroclysis is an X-ray examination of the small intestine. After a plain film (without X-ray contrast) of the abdomen is obtained, the radiologist will place a special nasogastric tube through the nose, and guide it through the stomach and into the jejunum (beginning part of the small intestine). Some numbing medication, or local anesthetic, may be used to help this process along. Under fluoroscopy, barium contrast is injected, and followed by the doctor until the small bowel has been visualized in its entirety. Films are obtained during and after this procedure, and studied in depth after the examination is finished. Return

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19.Sept.'03