Check-Cap Initiates EU Post Approval Study Using Advanced C-Scan®
Published: Mar 12, 2018
ISFIYA, Israel, March 12, 2018 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: 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 it has initiated an EU post approval study using its Advanced C-Scan system, which has demonstrated significant improvement in average colon imaging coverage compared with the C-Scan version used in the multi-center clinical study that supported the Company's CE Mark approval received in January 2018.
Advanced C-Scan incorporates the latest algorithms and system optimization. A fully autonomous and adaptive system, Advanced C-Scan tailors scanning of the colon to the patient's natural colonic movements to maximize the amount of the colon that is tracked and imaged.
In an interim clinical study of Advanced C-Scan, evaluable results of 21 patients showed average colon imaging coverage of 64%, a 40% improvement over 46% average colon imaging coverage in the CE Mark study. As demonstrated in the CE Mark study, sensitivity (ability to correctly identify polyps) is strongly correlated (R-squared = 0.98) to the percentage of colon imaging coverage. Sensitivity was 78% (p<0.05) for subjects with greater than 50% colon imaging coverage and 100% (p<0.05) for subjects with greater than 70% colon imaging coverage. Specificity (ability to correctly identify lack of polyps) was consistent at around 89%.
Alex Ovadia, CEO of Check-Cap stated, "We are very pleased to reach another target milestone and initiate our multi-center EU post approval study using Advanced C-Scan. We anticipate that the system will allow us to achieve clinical performance consistent with those seen in the CE study with majority colon imaging coverage. We are focused on executing on our programs, and holding productive discussions with regulatory agencies in support of Advanced C-Scan. We intend to continue to define our U.S. clinical pathway and we plan to submit supplementary filings to the EU Notified Body in our continued leverage of our CE Mark as we work to determine our marketing and commercial pathways throughout 2018."
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, an ingestible capsule-based system for preparation-free colorectal cancer screening.
Utilizing innovative ultra-low dose X-ray and wireless communication technologies, the capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities. Designed to improve the patient experience and increase the willingness of individuals to participate in recommended colorectal cancer screening, C-Scan removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation.
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SOURCE Check-Cap Ltd.
Company Codes: NASDAQ-SMALL:CHEK, Frankfurt:7CC, Stuttgart:7CC