ISFIYA, Israel and BOSTON, MA, September 27, 2017 - Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer screening, today announced that it has filed for the CE Mark registration of C-Scan. Data from the multi-center clinical investigation to support the submission showed safety and encouraging results for detecting patients with polyps in an un-prepped colon.

The objective of the study was to assess safety and the clinical performance of C-Scan in detecting patients with polyps. The three-center trial enrolled 66 patients, with a mean age of 59 years. Following capsule ingestion, subjects swallowed small doses of contrast agent and fiber supplements with each meal throughout capsule passage. Average capsule transit time was 52±32 hours, and the average total X-ray dose was 0.05 mSv (CT colonography effective dose is ~ 6.0 mSv). No bowel preparation, sedation, or change in diet was required. Both confirmatory colonoscopy, performed by an independent investigator, and C-Scan review, performed by a central review group, were blinded to results.

The study demonstrated a 44% sensitivity in the 45 subjects included in the analysis for polyps, with specificity of 89%. Sensitivity strongly correlated (R-squared = 0.98) to the percentage of the colon scanned. Sensitivity was 78% (p<0.05) and 100% (p<0.05) for subjects where greater than 50% and 70% of the colon was scanned, respectively. Specificity was consistent for all subjects.


Professor Nadir Arber, Principal Investigator and Prof. of Internal Medicine and Gastroenterology and Head of the Health Promotion Center and Integrated Cancer Prevention Center at the Tel-Aviv Sourasky Medical Center, stated: "These clinical results demonstrate C-Scan's positive safety profile and strong correlation between detection of patients with polyps and capsule scan coverage. Top line accuracy results are rather encouraging as well, as the sensitivity for advanced adenomas by stool testing, the primary colorectal cancer screening test in EU, demonstrates sensitivity ranges of 22% to 40%." Prof. Arber continued, "Despite evidence suggesting that polyp detection and removal can decrease CRC incidence and mortality, screening adherence remains disappointingly low. Many patients are unwilling to choose standard tests due to unpleasant bowel preparation requirements or stool collection. The promise of C-Scan is to provide a more patient-friendly option which could potentially increase screening rates. We look forward to additional research evaluating C-Scan for colonic polyp detection."

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