Business
Check-Cap Reports Fourth Quarter and Full Year 2019 Financial Results
Company planning to initiate a U.S. pivotal study of the C-Scan System in late 2020 Strengthened balance sheet through a $4.76 million private placement of
About this update from Check-cap Ltd.
[{"type":"text","content":"Company planning to initiate a U.S. pivotal study of the C-Scan System in late 2020\n Strengthened balance sheet through a $4.76 million private placement of ordinary shares\n\n\nISFIYA, Israel, March 6, 2020 /PRNewswire/ -- Check-Cap Ltd. (the \"Company\" or \"Check-Cap\") (NASDAQ: CHEK) (NASDAQ: CHEKZ), a clinical stage medical diagnostics company advancing the development of C-Scan®, the first and only patient-friendly preparation-free screening test to detect polyps before they transform into colorectal cancer, today announced financial results for the fourth quarter and full year ended December 31, 2019.\n \n \n2019 and Recent Highlights: \nContinued to advance the pre-submission process with FDA towards the initiation of a pivotal trial of the C-Scan System in late 2020 In February 2020, strengthened its balance sheet through a $4.76 million private placement of ordinary shares In December 2019, announced positive results from the U.S. pilot study of C-Scan that was performed at the NYU Grossman School of Medicine and Mayo Clinic of Rochester In August 2019, announced the completion of manufacturing line transfer implementation and qualification for the C-Scan System to our manufacturing partner, GE Healthcare, a leading global medical technology and life sciences company In July 2019, announced positive results from the post-CE approval study of C-Scan, which further validated the importance and potential of the system. \"We ended 2019 on a high note with the successful completion of our U.S. pilot study of the C-Scan System which, pending FDA approval, sets the stage for the initiation of a U.S. pivotal trial in late 2020,\" said Alex Ovadia, Chief Executive Officer of Check-Cap. \"There exists a significant global unmet need for a colon cancer screening and detection technology that is preparation free and non- invasive compared to the current standard of care, colonoscopy. We believe the patient-friendly C-Scan System can increase screening rates globally by eliminating the rigorous and unpleasant preparation that colonoscopy and other tests require.\n\"Colon cancer is a highly preventable disease, and an increase in global screening rates that we believe C-Scan can facilitate will result in earlier detection and improved long-term patient outcomes. We look forward to initiating a U.S. pivotal trial, as we work to intr...