Check-Cap Receives CE Mark Approval for C-Scan®

Thursday, January 11, 2018

Check-Cap Ltd., a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, today announced it has received CE Mark approval for the C-Scan system.

The C-Scan system offers an alternative to current colon cancer screening methods that require laxative preparation and invasive endoscopic procedures. This novel platform consists of a fully autonomous system that utilizes an ingestible, ultra-low dose X-ray capsule combined with a state of the art wireless tracking system, enabling generation of structural information on the lumen of the colon. This information is used to create 2D and 3D maps of the colon, allowing physicians to identify pre-cancerous polyps and other abnormalities. C-Scan is designed to improve the patient experience and increase the number of adults screened by eliminating procedural requirements frequently cited as barriers to adherence to screening guidelines such as bowel preparation, fasting, and sedation.

Bill Densel, CEO of Check-Cap commented, "Achieving CE Mark approval is a significant accomplishment and an important milestone for our Company.  This is a key validation of C-Scan and its potential as a convenient and comfortable option for identifying polyps in the colon. We look forward to continued progress on our initiatives and remain on target to commence our European post-approval and U.S. pilot trials, each in the 1H2018, as we define marketing and commercialization pathways throughout 2018."

Colorectal cancer is the third most common cancer diagnosed in both men and women and the second leading cause of cancer-related deaths. Despite evidence showing the removal of adenomatous polyps reduces CRC incidence and mortality, global screening rates remain low, with approximately 1.4 million new cases of CRC diagnosed world-wide each year, contributing to nearly 700,000 deaths.