New FDA Labeling for Capsule Endoscopy

We are pleased to announce that on July 2, 2003 Given Imaging received FDA clearance to remove the "adjunctive tool" qualifier, establishing the Given Diagnostic System as a first line tool in the detection of abnormalities of the small bowel.

The FDA’s decision, together with peer reviewed publications, confirm that Capsule Endoscopy should be the first line diagnostic tool to evaluate patients with persistent abdominal symptoms following a negative upper and lower endoscopy.

The FDA based its decision on clinical data showing an analysis of 32 independent studies with a total of 691 patients. Capsule endoscopy had a diagnostic yield of 71% whereas all the other modalities together had a total diagnostic yield of only 41%, clearly demonstrating the capsule’s absolute superiority in detecting small bowel abnormalities over all other traditional diagnostic tools.

The Meta Analysis Report included patients that 1) were enrolled in "bleeding" or "small bowel disorders" studies, and 2) had undergone a variety of inconclusive diagnostic procedures prior to enrollment in the Capsule Endoscopy comparative study. The results of the analysis are as follows:

% of Pathologies Found by Procedure Type - Graphic Pie Chart

New Pathologies Found Per Patient - Graphic Pie Chart

This change in the FDA indication for Capsule Endoscopy may directly impact the way in which insurance companies reimburse capsule endoscopy procedures. We’re prepared to assist you in working with your payers in the prior authorization process for these patients when necessary.

We appreciate your support and value your business. For more information, to contact us, or to unsubscribe, please visit www.givenimaging.com. Please let us know how we can best continue to help you.

Sincerely,
Nancy Sousa
President
Given Imaging, Inc.

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19.Sept.'03