Check-Cap has gained FDA approval for an Investigational Device Exemption (IDE) application, permitting Check-Cap to begin a pivotal study of C-Scan in the US. C-Scan is intended for candidates who are at average-risk for CRC and who are poor candidates for colonoscopy or decline colonoscopy, or who had an incomplete optical colonoscopy. The pivotal study will evaluate safety and performance of C-Scan as well as subject compliance with C-Scan.
"The IDE approval is a significant milestone for Check-Cap. Now with IDE in hand, we aim to enter the last phase of demonstrating the clinical potential of C-Scan in the US, with the ultimate goal of commercialisation in this important market," said Alex Ovadia, Chief Executive Officer of Check-Cap. "We are in active discussions with a number of clinical sites as part of our preparations to begin the pivotal study in late 2021. In parallel, as previously communicated, we will be continuing to optimise C-Scan's performance and patient experience through additional clinical data collection at Israeli sites. To this end, we are gearing up to initiate a study in Israel at more than ten clinical sites to enrol up to 250 average risk patients."
C-Scan is a capsule-based screening technology aims to significantly increase screening adherence worldwide and help millions of people to stay 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.
"We are also pleased to announce that the FDA has approved the company's Breakthrough Device Designation for the intended use of identifying candidates within the average risk population who are at elevated risk for polyps equal to or larger than 1 cm and are poor candidates for colonoscopy,” Ovadia continued. “We believe that this highlights the FDA's recognition of C-Scan as an alternative method to address the significant unmet need for patient-friendly CRC screening, in particular since it enables the detection of colorectal polyps before they may turn into cancer.”