Israel's Given Imaging ($GIVN) has begun the pivotal PillCam COLON 2 study to support its planned regulatory submission to Japan's Pharmaceuticals and Medical Devices Agency.
The study will evaluate 72 patients between the ages of 40 and 75 with polyps that previously have been identified by optical colonoscopy with the PillCam COLON 2 capsule endoscopy procedure. The primary endpoint of the study is identifying polyps greater than or equal to 6 millimeters. Given expects enrollment will wrap up by the end of March 2012, and a regulatory submission will be ready in the middle of next year.
"We are pleased to initiate the PillCam COLON 2 trial in Japan and are committed to bringing this new modality for colorectal screening to those who can benefit from alternatives to colonoscopy," Homi Shamir, Given's president and CEO, said in a statement. "PillCam COLON 2 is recognized by both the GI community and regulatory authorities in Japan as having significant clinical value, and we believe this product can positively impact the low rate of colorectal cancer screening in Japan as well as other countries."
PillCam COLON 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, Australia and parts of Asia. A pivotal study is under way in the U.S.
Given is a pioneer in capsule endoscopy, the company notes on its website. Furthermore, roughly a million patients worldwide have benefited from PillCam capsule endoscopy. In fact, Shamir told FierceMedicalDevices recently that the company pretty much invented a space that didn't exist a decade ago, and it is continuing to grow.
Shamir and other Given officials told FMD the company has seen success as of late. It has been particularly active in China, and has seen good news in some European markets, particularly Germany and France. And while it doesn't have a huge presence in India yet, the company is putting some effort in there.
Given also has been active in the M&A arena, picking up Sierra Scientific last year for $35 million. At the time, Given said Sierra's technology, along with its own Bravo pH Monitoring System, make it the leader in the esophageal diagnostics market. Shamir told FMD his company has a lot of cash, so it would consider making other M&A moves were the right opportunities to present themselves.
- check out Given's release