Check-Cap Announces C-Scan System Version 3 Interim Results

The objective of the study is to assess safety and clinical performance of the C-Scan system Version 3 in detecting patients with polyps. In a recent multi-center study on 31 evaluable patients, the C-Scan system Version 3, equipped with improved algorithms, demonstrated a sensitivity (ability to correctly identify polyps) of 76% (P=0.0038), with specificity (ability to correctly identify lack of polyps) of 80% for polyp detection, when using the full patient population with a gender-based analysis. Confirmatory colonoscopy and C-Scan system results analysis were performed by independent expert investigators who were blinded to corresponding test's results.

Improvements to the C-Scan system version 3 include better scan imaging density, 2D/3D imaging and a new motility analysis algorithm that was recently tested on two years of continued clinical study data.

"We are excited to unveil the multidimensional screening capabilities of the C-Scan system. We believe that the encouraging interim results from our ongoing post CE approval study demonstrate a significant progress in the clinical performance of C-Scan compared with previously communicated CE study results for our patient-friendly, and preparation free colon-cancer screening device," Alex Ovadia, CEO of Check-Cap, said. "These results were achieved through the continuous improvements in cross-system algorithms, while maintaining C-Scan's strong safety profile. As our post CE approval study continues, with final results planned in 2Q/19 on a more substantial number of patients, we look forward to delivering on our near-term milestones for the remainder of 2018 and forward, including the establishment of the GE manufacturing line and regulatory path in the United States towards the expected initiation of our U.S. pilot trial in 4Q/18."

Colorectal cancer is the second leading cause of cancer death in the United States, with an estimated 135,000 diagnoses and 50,000 deaths in 2017. Despite compelling evidence that screening can detect colorectal cancer and precancerous polyps, nearly one-third of the recommended adult population has never been screened. The C-Scan system is designed to improve patient experience with screening by eliminating many uncomfortable and invasive requirements of other colon screening procedures, such as bowel preparation, fasting and sedation.

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