Given Imaging Ltd. (GIVN)

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Given Imaging Receives Reimbursement Approval for PillCam COLON(R) in Japan Effective January 1, 2014

Monday 11 November 2013

Given Imaging (Nasdaq:GIVN), a world leader in specialty GI products and pioneer of capsule endoscopy, today announced that Japan's Central Social Insurance Medical Council (Chuikyo) has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare (MHLW) to provide reimbursement for Given Imaging's PillCam COLON. With this approval, Chuikyo established a reimbursement of 83,100 JPY, or roughly $840.00 USD (using current exchange rate), per capsule that is scheduled to go into effect on January 1, 2014. This decision follows regulatory clearance of PillCam COLON in July of this year by Japan's Pharmaceuticals & Medical Devices Agency (PMDA). The MHLW will determine the final indication for use for PillCam COLON in December as well as the amount for the professional fee.
PillCam COLON

A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=22126

"We thank the Japanese government for moving so quickly to provide reimbursement for PillCam COLON so that more patients can have access to a safe and effective diagnostic and screening tool for detecting diseases of the colon," said Homi Shamir, President and CEO, Given Imaging. "We are training our team now so that we can maximize this opportunity in 2014."

Screening guidelines in Japan call for everyone over 40 to undergo a fecal occult blood test (FOBT). Compliance with screening remains low and only 27% of the population actually gets tested.1 After a physician identifies blood in a patient's stool, which can be a strong indication of colon cancer or other diseases, only 58% of these patients proceed to have a recommended colonoscopy to confirm the diagnosis due to a variety of reasons.2 PillCam COLON's ease of use and minimally-invasive profile could appeal to those patients.

About Given Imaging Ltd.

Since pioneering the field of capsule endoscopy in 2001, Given Imaging has become a world leader in GI medical devices, offering health care providers a range of innovative options for visualizing, diagnosing and monitoring the digestive system. The company offers a broad product portfolio including PillCam® capsule endoscope for the small bowel, esophagus and colon. The company also offers industry-leading GI functional diagnostic solutions including ManoScan® high resolution manometry, Bravo® capsule-based pH monitoring, Digitrapper® pH-Z monitoring, and SmartPill® motility monitoring systems. Given Imaging is committed to delivering breakthrough innovations to the GI community and supporting its ongoing clinical needs. Given Imaging's headquarters are located in Yoqneam, Israel, with operating subsidiaries in the United States, Germany, France, Japan, Australia, Vietnam, Hong Kong and Brazil. For more information, please visit givenimaging.com.