Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has filed for approval with Japan's Pharmaceuticals and Medical Devices Agency for the company's PillCam Colon 2 endoscopic capsule, on the basis of a successful pivotal trial for the diagnosis of colorectal cancer and other diseases.
The pivotal trial for the PillCam Colon 2 found that the capsule enabled physicians to accurately identify 94% of polyps that were at least 6 mm in size previously identified using standard colonoscopy. Given Imaging obtained EU CE Mark for the PillCam Colon 2 received in September 2009, and it is commercially available throughout Europe, Latin America, Canada, and parts of Asia.
Given Imaging president and CEO Homi Shamir said, "We are very pleased with the robust results of our PillCam Colon 2 clinical trial in Japan as well as the performance of the PillCam Colon 2 capsule. We believe that PillCam Colon 2 can be a useful tool for physicians to visualize and diagnose colon polyps. With an estimated addressable market of approximately one million procedures each year in Japan, PillCam Colon 2 represents a significant revenue opportunity for Given Imaging."
Given Imaging says that 42,000 people died of colorectal cancer in Japan in 2009.
Given Imaging's share price rose 0.4% in morning trading on the TASE today to NIS 52.84, after falling 2.1% on Nasdaq yesterday to $13.35, giving a market cap of $412 million.
Published by Globes [online], Israel business news - www.globes-online.com - on September 19, 2012
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