Given Imaging landed a win in Japan for its bite-sized pill camera used to detect colon disease. The PillCam Colon was cleared for sale this week by the island nation’s Pharmaceuticals & Medical Devices Agency and could expand the company’s Japanese market reach 10-fold, according to a press release.
The Yoqneam, Israel-based medical device maker markets the camera as an alternative to traditional colonoscopy with the potential to boost compliance rates for colonic disease screening.
"The clearance of PillCam Colon in Japan, the world’s 2nd largest healthcare market, represents an important accomplishment for Given Imaging," said CEO Homi Shamir in prepared remarks. "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."
The PillCam Colon device is still waiting for an FDA green light, but it has been cleared in Europe, Latin America, Canada and parts of Asia. Given initially submitted FDA applications in Dec. 2012.
The PillCam device is designed for patients unwilling or unable to undergo traditional colonoscopy. Only 25% of the Japanese patient population goes in for their recommended fecal occult blood test, but the disease incidence rate is increasing, according to the company release.
"The number of deaths due to colorectal cancer in Japan continues to increase at an alarming rate," Dokkyo Medical University Emeritus president Dr. Akira Terano said in prepared remarks on behalf of the company. "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."
"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," Terano added.