ISFIYA, Israel, December 14, 2015 - Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical stage medical diagnostics company engaged in the development of an ingestible capsule for preparation-free, colorectal cancer screening, today announced that data related to its clinical studies have been published in Gut, an official peer-reviewed journal of the British Society of Gastroenterology.
The article, entitled "A Novel Prepless X-ray Imaging Capsule for Colon Cancer Screening," includes safety and motility data collected in Europe and Israel on passage of the capsule through the GI tract, as well as a preliminary analysis of the first participants evaluated in the Company's ongoing multi-center clinical feasibility study, which aims to establish the safety, functionality and preliminary efficacy of the Check-Cap system.
"The importance of routine colorectal cancer screening is well understood. Colorectal cancer, or CRC, develops slowly and is therefore highly preventable. However, there are logistical and patient-related barriers that hamper participation in current screening procedures such as colonoscopy. These barriers include bowel cleansing requirements, risks associated with anesthesia and patient concerns over potential pain," said Prof. Nadir Arber, M.D., Director, Integrated Cancer Prevention Center at the Israel Tel Aviv Sourasky Medical Center, president of the Israeli Gastroenterological Society and scientific advisor to Check-Cap. "These data validate the potential of a less invasive, patient-friendly modality that can screen the colon's interior and provide 3D imaging of the colonic wall without the need for bowel preparation."

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Preliminary analysis of the ongoing clinical feasibility study evaluated data from participants who swallowed Check-Cap's scanning capsule, tracking the entire passage of the capsule through the alimentary tract using radio frequency telemetry and Check-Cap's proprietary capsule position tracking system. Pedunculated and sessile polyps were clearly seen and validated by subsequent colonoscopy, and the total radiation exposure was found to be ultra-low (0.03±0.007 mSv, or the equivalent exposure of one chest x-ray). Capsules were excreted naturally in all 48 volunteers who completed the study (one asymptomatic volunteer withdrew prior to completion and the capsule was retrieved endoscopically from the colon). Initial data show the system to be safe, as well as able to produce 3D reconstructions of the colonic wall and lumen, including identifying polyps.