Given Imaging Announces U.S. Market Clearance Of Pediatric Accessory Kit

Yoqneam, Israel, February 24, 2004 - Given Imaging Ltd. (NASDAQ: GIVN) today announced that the specialized Pediatric Accessory Kit and Pediatric DataRecorder have been cleared to market in the U.S. to facilitate pediatric use of the M2A capsule endoscope. Today's announcement follows the clearance received in October 2003 to market capsule endoscopy for use in pediatric patients ages 10-18.

Designed for children and small stature patients, the Pediatric Accessory Kit consists of the Pediatric Recorder Belt, and the Pediatric SensorArray. Both are smaller versions of the previously available adult versions. The Pediatric Accessory Kit is available immediately for customers who currently have a Given Imaging DataRecorder Kit. The new Pediatric DataRecorder Kit includes a DataRecorder and a new Li-Ion battery set, comprised of a lighter weight battery and the Li-Ion Battery Charger. The new Pediatric DataRecorder Kit will be available starting April 1.

There are approximately 1,050 members in the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition (including members in the U.S., Canada and Puerto Rico) who provide care to children with gastrointestinal diseases for which these products are now available.

About Given Imaging
Given Imaging develops, produces and markets the GivenŽ Diagnostic System featuring the M2AŽ 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 M2AŽ 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 M2AŽ 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 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.

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.

Back to Menu
19.May'04