Given Imaging Announces Study Shows M2A Capsule Endoscope Enables Diagnosis of Patients Suffering from Persistent Gastrointestinal Symptoms

Capsule endoscopy seen as valuable diagnostic tool in patients with suspected Crohn’s disease

YOQNEAM, Israel - July 21, 2003 - Given Imaging (NASDAQ: GIVN) announced today that a study published in the July issue of Endoscopy (Endoscopy 2003:35:1- 5) concludes that capsule endoscopy is valuable in diagnosing patients with suspected Crohn’s disease who suffer from persistent gastrointestinal symptoms such as chronic diarrhea and recurrent abdominal pain that often can not be diagnosed by traditional diagnostic techniques.

J.M. Herrerías, MD, Gastroenterology Service of the Virgen Macarena University Hospital in Seville Spain conducted the study that evaluated 21 patients with a mean age of 43±8 years with suspected Crohn’s disease. All of the patients had previously received complete small bowel imaging work-up including upper and lower endoscopy and a small-bowel follow through. These conventional diagnostic techniques did not yield conclusive findings. All 21 patients were also given Capsule Endoscopy (CE). Images of lesions captured by CE supported the diagnosis of Crohn’s in nine patients (43%). All nine patients were subsequently treated with standard therapy for Crohn’s disease and were reported to be in clinical remission.

"Patients suffering from persistent symptoms such as diarrhea, abdominal pain, and weight loss present a clinical suspicion of Crohn’s disease, but standard diagnostic work-ups such as gastroscopy, colonoscopy or barium radiology often show up negative. This study shows that capsule endoscopy is a valuable diagnostic tool for these patients, by providing images of pathologies representing Crohn’s disease of the small intestine," said Dr. J.M Herrerías.

About Given Imaging
Given Imaging develops, produces and markets the Given® Diagnostic System featuring the M2A® 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