Given Imaging’s colon capsule gets EU approval

Given Imaging’s stock rose 8% in response to the announcement; the company will file an application with the FDA by the end of the year.

22 October 06 17:16, Gitit Pincas

Given Imaging (Nasdaq: GIVN; TASE: GIVN) announced last week that it received the CE Mark to market PillCam Colon throughout the European Union. The company said it would unveil the product to physicians at the United European Gastroenterology Week (UEGW) in Berlin, Germany from October 21-25, adding that it will release the PillCam Colon to the market gradually following the completion of additional clinical trials. Given Imaging rose 7.8% on Wall Street on Friday, reflecting a market cap for the company of $600 million.

In its announcement Given Imaging added that it expects to file for clearance of PillCam Colon with the US Food and Drug Administration (FDA) by the end of 2006. After the lesson it learned with its camera capsule for the esophagus, it is clear that the company will have to reach the market via a Sisyphean path that will entail the obtaining of a current procedural terminology (CPT) code from insurance companies and the adoption of the capsule by them of the reimbursement of its cost to patients. This means that the company’s new colon capsule is unlikely to generate significant revenue until 2008-09, just as the esophagus capsule has all but failed to generate any revenue to date.

The capsule is a similar size to a regular vitamin capsule. In view of the harsher conditions under which the capsule will function inside the colon, which is wider, more turbid and divided into cells, the capsule has new features that were not included in previous products, such as cameras with a faster rate of image processing.

Given Imaging president and CEO Homi Shamir said last week, “Today begins a new chapter for our company and confirms our leadership in the field of capsule endoscopy. To this end, the initial PillCam Colon data is encouraging and we believe it will be an effective tool for physicians to visualize the colon.”

Given Imaging will publish its financial report for the third quarter of 2006 before the start of trading on Wall Street on November 2.

Published by Globes [online], Israel business news - www.globes.co.il - on October 22, 2006

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