Given Imaging Announces First Publication of Prospective Study Showing Superiority of Capsule Endoscopy in Diagnosing Crohn's Disease

Shows capsule endoscopy as superior to barium follow-through (x-ray) and entero-CT in diagnosing suspected Crohn’s disease

4/9/2003 - YOQNEAM, Israel - Given Imaging Ltd. (NASDAQ: GIVN) today announced that a study published in the European Journal of Gastroenterology & Hepatology 2003, 15:363-367 concluded that the M2A capsule is an effective, sensitive and valuable diagnostic tool in the early diagnosis of Crohn’s disease.

"Capsule endoscopy is a superior and more sensitive procedure than barium follow-through and entero-CT in establishing the diagnosis and estimating the extent of Crohn’s disease," said Dr. Rami Eliakim, Head of the Department of Gastroenterology, Rambam Medical Centre, Bat Galim, Haifa and President of the Israeli Gastroenterology Association. "It is conceivable that it will become the first line of investigation in patients with early or suspected Crohn’s disease."

The study examined twenty patients with suspected Crohn’s disease who experienced symptoms which included recurring abdominal pain, weight loss or chronic diarrhea. The mean duration of symptoms before enrollment in the trial was 8 months. The group of patients had to undergo a total of 48 procedures including gastroscopy, colonoscopy, small bowel follow-through, plain abdominal, computer tomography prior to the trial.

Capsule endoscopy established new diagnoses, confirmed existing diagnoses, enlarged the extent of the disease and ruled out the suspicion of Crohn’s disease in 70% of patients. In comparison, barium follow-through established diagnoses, measured the extent of the disease, and ruled out the suspicion of Crohn’s disease in 37% of patients. In addition, capsule endoscopy detected all of the lesions diagnosed by barium follow-through and entero-CT, and detected additional lesions that were not detected by other modalities in 47% of cases and ruled out lesions detected by other modalities in 16% of cases (P<0.05).

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19.Sept.'03