Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) today announced that Japan’s Pharmaceuticals & Medical Devices Agency (PMDA) has cleared the company's PillCam Colon endoscopic capsule for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.
"The clearance of PillCam Colon in Japan, the world's second largest healthcare market, represents an important accomplishment for Given Imaging," said Given Imaging president and CEO Homi Shamir. "The decision could expand our potential customer base in Japan from 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over one million potential patients."
Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only approximately 25% of the population actually get tested. After a physician identifies blood in a patient’s feces (which can be a strong indication of colon cancer or other diseases), only 54.7%of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons. PillCam Colon’s ease of use and minimally-invasive profile could appeal to those patients.
"Meaningful sales of PillCam Colon capsule will commence immediately after obtaining reimbursement," said Shamir, although he declined to provide specifics. "I do not want to discuss financial numbers at this time, because the level of indemnification is not known."
Given Imaging also expects the US Food and Drug Administration (FDA) to approve the PillCam Colon by the end of September. It received EU CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia.
Given Imaging's parent company, IDB Holding Corp. Ltd. (TASE:IDBH), controlled by Nochi Dankner, wants to sell the company.
Published by Globes [online], Israel business news - www.globes-online.com - on July 15, 2013
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