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Check-Cap Announces Expansion of Manufacturing Capacity and Production Line to Support U.S. Pivotal Study Initiation

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Oct. 17, 2021
Courtesy ofCheck-Cap Ltd.

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 may transform into colorectal cancer (CRC), today announced the expansion of C-Scan`s manufacturing capacity and on-premise production line, as well as the remediation of technical issues from a single source supplier. The significant expansion of the Company`s production line is intended to support its U.S. pivotal study, expected to commence towards the end of Q1 2022.

"We are pleased to report the significant progress made to improve supply chain and quality infrastructure, accompanied by further strengthening of our qualified team, to support our U.S.pivotal study needs," said Alex Ovadia, chief executive officer of Check-Cap. "We continue to advance towards our critical goal of initiating the U.S. pivotal study by the end of March 2022 and are focused on accelerating the optimization of C-Scan`s functionality and patient experience through additional clinical data collection atIsraelisites. We are committed to bringing this much-needed CRC prep-less screening modality as soon as practically possible to the many people in need of a patient-friendly option for the detection of precancerous polyps."

About Check-Cap

Check-Cap is a clinical stage medical diagnostics company aiming to redefine colorectal cancer (CRC)screening through the introduction of C-Scan®, thefirst and onlypatient-friendly preparation-freescreening test to detect polypsbeforethey may transform into colorectal cancer and enable early intervention and cancer prevention. The Company`sdisruptivecapsule-basedscreening technology aims to significantly increasescreening adherenceworldwide and help millions of people tostay healthy through preventive CRC screening. C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3D map of the inner lining of the colon as it travels naturally along the gastrointestinal tract. C-Scan is non-invasive and requires no sedation. Unlike other capsule technologies, it requires no bowel preparation, allowing the patients to continue their daily routine with no interruption. C-Scan is not intended to replace colonoscopy. A positive C-Scan result should be followed by colonoscopy.

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