The FDA has approved Check-Cap Ltd's (NASDAQ:CHEK) amended Investigational Device Exemption (IDE) application to initiate the U.S. pivotal study of C-Scan.
- The U.S. pivotal study consists of two parts. The first part is designed further to calibrate the system for the average risk U.S. population.
- The second part will include a statistically powered, randomized study that will compare C-Scan's performance to traditional colonoscopy.
- The Company is focused on final preparations to initiate the first part of the U.S. pivotal study, anticipated to begin in March-April 2022, followed by initiation of the second part of the study in Q4 2022.
- Related content: Benzinga's Full FDA Calendar.
- C-Scan is the first and only patient-friendly preparation-free screening test to detect polyps before they might transform into colorectal cancer and enable early intervention and cancer prevention.
- C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, and proprietary software to generate a 3D map of the colon's inner lining as it travels naturally along the gastrointestinal tract.
- C-Scan is non-invasive and requires no sedation.
- Price Action: CHEK shares are trading 9.19% higher at $0.65 during the market session on the last check Monday.
