Business
Check-Cap Reports Second Quarter 2019 Financial Results and Corporate Highlights
ISFIYA, Israel, Aug. 7, 2019 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical stage
About this update from Check-cap Ltd.
[{"type":"text","content":" ISFIYA, Israel, Aug. 7, 2019 /PRNewswire/ -- Check-Cap Ltd. (the \"Company\" or \"Check-Cap\") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only preparation-free ingestible capsule based system for the prevention of colorectal cancer through the detection of precancerous polyps, today announced financial results for the second quarter and six months ended June 30, 2019.\n\n \nSecond Quarter and Recent Highlights:\nAnnounced positive final results from its post-CE approval study of the C-Scan System. The study met its primary endpoint, achieving sensitivity (ability to correctly identify patients with polyps) of 76% in patients with polyps ≥10 mm and specificity (ability to correctly identify patients with lack of polyps) of 82% in all patients, compared to FIT that achieved 29% sensitivity and 96% specificity. In addition, the C-Scan System detected all 4 patients (100%) with polyps ≥40 mm, while FIT detected only 1 of the 4 patients (25%) with polyps ≥40mm. Overall, the C-Scan System achieved a sensitivity of 66% in all patients, including patients with polyps <10mm, while FIT achieved a sensitivity of 23% for the same population.Progressed the U.S. pilot study of the C-Scan System at NYU School of Medicine and Mayo Clinic which is evaluating the safety, usability and subject compliance in up to 45 subjects. Results from the U.S. pilot study, if positive, would represent another major milestone towards the initiation of the planned U.S. pivotal study in 2020.Appointed Joshua (Shuki) Belkar as Vice President of Operations, bringing more than 20 years of experience managing operations at global medical device companies, including Medtronic and Mazor Robotics.Presented a poster at Digestive Disease Week®, entitled \"Swallow and forget\" study: Prepless X-Ray imaging capsule with enhanced algorithms shows substantial improvement in polyp detection.\" \"During the first half of 2019, we achieved two very significant milestones,\" said Alex Ovadia, Chief Executive Officer of Check-Cap. \"First, we initiated our U.S. pilot study, which, if it yields positive results, will set the stage for a planned pivotal study next year. Second, we reported compelling results from our post-CE approval study, which add to the growing body of evid...