• Broad Indication Could Benefit Over One Million Patients Per Year in Japan
  • Significantly Broadens Given Imaging's Potential Capsule Endoscopy System Customer Base

Given Imaging Ltd, (Nasdaq:GIVN), a world leader in gastrointestinal medical devices and pioneer of capsule endoscopy, today announced that PillCam® COLON has been cleared by Japan's Pharmaceuticals & Medical Devices Agency (PMDA) for diagnosis of colonic disease when colonoscopy is required but difficult to conduct, including patients unwilling or unable to undergo colonoscopy.

"We thank the PMDA for its very efficient review process and for granting a broad indication for PillCam COLON," said Homi Shamir, President and CEO, Given Imaging. "The clearance of PillCam COLON in Japan, the world's second largest healthcare market, represents an important accomplishment for Given Imaging. The decision could expand our potential customer base in Japan from approximately 1,000 today to potentially 10,000 and will help in enhancing adherence to screening guidelines for over 1,000,000 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.1 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 patients2 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.

"The number of deaths due to colorectal cancer in Japan continues to increase at an alarming rate," said Akira Terano, MD, PhD, Emeritus president, Dokkyo Medical University, president, Japanese Association for Capsule Endoscopy (JACE). "Colorectal cancer is now the leading cause of cancer death in women in Japan and the incidence rate for colorectal cancer in men and women is expected to be at the top of the list in the population of Japan by 2020. PillCam® COLON is a less invasive medical device which would be able to drive higher compliance. I believe that PillCam® COLON would make a huge contribution for early detection and treatment of colon cancer by applying it in the clinical setting. JACE would undertake the central role in research, education and the upgrading of the medical system for the capsule endoscopy of the colon. I believe PillCam COLON will be widely accepted into the clinical practice for patients who are not able or unwilling to undergo a colonoscopy due to physical or psychological reasons or who do not have a convenient access to a medical (colonoscopy) facility near their place of residence."

"Our top priority is to provide physicians and patients with an alternative colorectal exam option to ensure every patient, including those who are unable or unwilling to get a colonoscopy, has the opportunity to undergo a colorectal exam," Shamir said. "Meaningful sales of PillCam COLON capsule will commence immediately after obtaining reimbursement."

Reimbursement in Japan is expected to become effective during the first half of 2014, subject to government discretion. PillCam COLON received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, and parts of Asia. PillCam COLON is pending U.S. Food and Drug Administration (FDA) clearance and is not cleared for marketing or available for commercial distribution in the U.S. and certain other countries.

1 Ministry of Health, Labor and Welfare, 2007 Health Review of Japanese Households,– 2007

2 "Nationwide Survey Committee of Mass Screening for Digestive Organs of the Japanese Society of Gastroenterological Cancer Screening: annual report of 2008 of the nationwide survey of mass screening for digestive organs," Journal of Gastroenterol Cancer Screening, vol. 49, pp. 73-112, 2011.