Given Imaging Announces FDA Establishes M2A as First Line Test for Imaging Small Bowel Mucosa

Clearly the new gold standard for diagnosis of small bowel disorders

YOQNEAM, Israel - July 8, 2003 - Given Imaging (NASDAQ: GIVN) announced today that the company has received FDA clearance establishing the Given Diagnostic System as a first line tool in the detection of abnormalities of the small bowel, removing the "adjunctive tool" qualifier.

The FDA based its decision on clinical data showing an analysis of 32 independent studies with a total of 691 patients. The analysis compared the Given Diagnostic System with other modalities including gastroscopy, colonoscopy, small bowel follow through (SBFT), push-enteroscopy, CT scan, abdominal x-ray, angiography, and intra-operative enteroscopy. Capsule endoscopy had a diagnostic yield of 71% whereas all the other modalities together had a total diagnostic yield of only 41%.

"When you consider that capsule endoscopy offers superior diagnoses and is a painless procedure, this is really excellent news for patients since they will no longer have to endure multiple inconclusive GI diagnostic procedures," said Dr. Blair Lewis, Professor of Medicine at Mt. Sinai Hospital in New York. "We anticipate that being able to offer capsule endoscopy as a first-line diagnostic procedure will change the way that we treat patients suffering from disorders of the small bowel."

"We are very excited about the FDA’s decision which was based on empirical evidence that shows the capsule endoscope’s absolute superiority in detecting small bowel abnormalities over all other traditional diagnostic tools," said Gavriel D. Meron, President and CEO of Given Imaging. "Capsule endoscopy has been recognized by the FDA as the standard first-line diagnostic tool for small bowel disorders. Based on today’s news, we anticipate that private and public insurers will adjust current policies and issue new policies to cover the first-line use of the Given® M2A capsule for suspected disorders of the small intestine."

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.Sept.'03