Given Imaging Announces Results of 100 Patient M2A® Capsule Endoscopy Outcome Study Published In Gastroenterology

Results prove M2A® Capsule Endoscope is highly sensitive and specific in patients with obscure GI bleeding

Yoqneam, Israel - March 18, 2004 - Given Imaging Ltd. (NASDAQ: GIVN) today announced publication of a 100-patient multicenter outcome study evaluating the M2A® Capsule Endoscopy's sensitivity and specificity as well as patient outcomes following Capsule Endoscopy in patients with obscure gastrointestinal bleeding. The study, which appears in the March issue of Gastroenterology, concludes that in addition to being a simple and extremely well tolerated procedure, Capsule Endoscopy provided information critical to change patient management by guiding subsequent diagnostic and therapeutic measures.

Importantly, this clinical study sought to establish Capsule Endoscopy's sensitivity, as measured by the number of positive diagnoses reached, and specificity, as measured by the percentage of negative final diagnoses reached. To this end, of the 62 patients that underwent further examinations, verification of the capsule's findings was made in 56 patients: 36 of these had a positive final diagnosis and 20 a negative final diagnosis. Capsule Endoscopy was positive in 32 of the 36 patients with positive final diagnoses indicating sensitivity of 88.9% and negative in 19 of the 20 with negative final diagnoses indicating a specificity measure of 95%. The overall accuracy of Capsule Endoscopy was 91.1%. Patient management was changed, following diagnosis with Capsule Endoscopy, in 86.9% of patients diagnosed, who were treated and whose conditions were resolved.

&ldqup;Capsule Endoscopy is an effective diagnostic tool for patients with obscure GI bleeding and, if used early in the course of the work-up, can considerably shorten the time to diagnosis, lead to earlier therapeutic or surgical treatment in some patients and spare others from having to undergo additional diagnostic tests,” said Marco Pennazio, MD Division of Gastroenterology, S. Giovanni Antica Sede Hospital, Turin, Italy.

The study was led by physicians at the S. Giovanni Antica Sede Hospital in Turin Italy, and the IRCCS Maggiore Policlinico Hospital in Milan, Italy between January 2001 and March 2002. All patients had undergone recent negative upper and lower endoscopies. All patients were significantly anemic prior to undergoing Capsule Endoscopy and 88% had been hospitalized at least once for their condition. In addition, 73% underwent blood transfusions. In total, these patients had undergone a total of 620 diagnostic tests prior to Capsule Endoscopy, all with negative results. These tests included esophagogastroduoendoscopy, colonoscopy, small bowel follow through, enteroclysis, enteroscopy, Tc99 red cellscan, Meckel's scan, CT scan, angiography, and laparoscopy.

About Given
Imaging Given Imaging develops, produces and markets the Given® Diagnostic System featuring the M2A® Capsule Endoscope, the only method for direct visualization of the entire small intestine that is naturally ingested. 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. More than 80,000 capsules have been used in clinical practice. Thousands of patients around the world have benefited from the M2A® Capsule which has been used to diagnose a range of diseases of the small intestine including Crohn's Disease, Celiac disease and other malabsorption disorders, benign and malignant tumors, vascular disorders and medication-related small bowel injury, as well as a range of pediatric small bowel disorders. For more information, visit www.givenimaging.com.

This press release contains forward-looking statements about Given Imaging, including projections about our business, our future revenues, and our future profitability, within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. For example, statements in the future tense, words such as "anticipates," "estimates," "expects," "intends," "plans," "believes," and words and terms of similar substance used in connection with any discussion of future operating or financial performance identify such forward-looking statements. Those forward-looking statements are not guarantees of future performance and actual results could differ materially from our current expectations as a result of numerous factors, including but not limited to the following: changes in regulatory environment, our success in implementing our sales, marketing and manufacturing plan, protection and validity of patents and other intellectual property rights, the impact of currency exchange rates, the effect of competition by other companies, the outcome of future litigation, the reimbursement policies for our product from healthcare payors, quarterly variations in operating results, the possibility of armed conflict or civil or military unrest in Israel and other risks disclosed in our filings with the U.S. Securities Exchange Commission.

19.May'04