Business
Check-Cap Issues an Update to Shareholders
ISFIYA, Israel, March 21, 2023 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK), (NASDAQ: CHEKZ), a clinical stage medical
About this update from Check-cap Ltd.
[{"type":"text","content":"ISFIYA, Israel, March 21, 2023 /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 bowel prep-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today issued the following letter from its chief executive officer, Alex Ovadia, to its shareholders and the investment community:\n \nDear Check-Cap Shareholders,\nWe greatly appreciated your support throughout 2022, a year during which we continued to conduct the C-Scan clinical programs in the U.S. and Israel, while strengthening our manufacturing capabilities and production line. In this communication we wanted to share updates about our C-Scan program.\nIn May 2022, we initiated the first part of the U.S. pivotal study of C-Scan, which focuses on device calibration and enhancement of C-Scan algorithms among the average risk U.S. population.\nIn parallel, to support the calibration portion of the U.S. pivotal study, we continued enrolling average risk patients in our study in Israel. To date, the Company has enrolled more than 300 average risk patients as part of its Israeli study and only 17 average risk patients in the first part of its U.S. pivotal study, mainly as a result of slower than expected U.S. site recruitment pace, due to licensing requirements with local states associated with the X-ray technology within our C-Scan capsule.\nWhile prior C-Scan trial performance was based on an enriched population (i.e., subjects with known polyps), the current calibration studies' target is to optimize the C-Scan device for the average risk population prior to commencing the powered portion of the U.S. pivotal study, which aims to demonstrate C-Scan performance in a statistically significant manner. The initiation of the powered potion of the U.S. pivotal study was dependent upon successful completion of the calibration portion of the U.S. pivotal study.\nFollowing our internal assessment of the clinical data collected to date from our calibration studies, the Company has determined that the current efficacy results do not meet our goal in order to proceed to the powered portion of the U.S. pivotal study.\nAs a result, the Company adopted a plan of action that includes conducting a...