YOQNEAM, ISRAEL--(Marketwire - February 18, 2008) - Given Imaging Ltd. (NASDAQ: GIVN), the global leader in capsule endoscopy, today announced that the U.S. Food and Drug Administration (FDA) has sent the company a not substantially equivalent (NSE) letter regarding its 510(k) application to market PillCam® COLON in the United States. “While we are disappointed by the FDA’s decision we are evaluating our options to bring PillCam COLON to the U.S. market as quickly as possible,” said Homi Shamir, president and CEO of Given Imaging. “We recently launched PillCam COLON in Europe and in other countries, and we are working closely with leading GI clinicians to determine its optimal role in patient care. On a parallel track and consistent with our commitment to innovation, we are accelerating development of a next generation colon capsule,” added Mr. Shamir. The Company does not expect this decision to have a material impact on 2008 revenues as PillCam COLON capsule sales in the U.S. were not projected to be significant in 2008. As previously announced, the Company will publish its audited financial results for the fourth quarter and full year 2007, and provide 2008 financial guidance following the close of trading on Wednesday, February 20, 2008. The company will host a conference call in Hebrew at 7:00am ET and in English at 9:00am ET on Thursday, February 21 to discuss these matters.
