Israeli cancer-screening device innovator, Check-Cap Ltd., has announced the enrollment of the first patient in its multi-center study of the C-Scan® system in support of its CE Mark submission.
We’ve been watching this one for some time now. Check-Cap is a clinical stage medical diagnostics company developing a capsule-based system for preparation-free, colorectal cancer (CRC) screening. Its C-Scan employs proprietary, ultra-low-dose X-ray technology in an ingestible capsule to create a 3D map of the inner colon to detect polyps, which may be, or may become, cancerous. Unlike existing imaging modalities, Check-Cap’s approach does not require bowel preparation, which is a significant obstacle to screening. Designed to improve the patient experience and maximize the number of people who complete screening, C-Scan works in concert with the natural functioning of the colon, and does not require sedation or changes to diet and normal daily activities.
The current multi-center, prospective trial, designed to demonstrate the safety and clinical performance of C-Scan, will evaluate polyp detection as compared to colonoscopy. Check-Cap expects to submit for a CE Mark in the first half of 2017.
“Completing the optimization of our system and initiating the trial to support CE Marking is a very positive step forward in the development of a more patient-friendly alternative to today’s invasive and preparation-intensive approaches to CRC prevention,” said Bill Densel, CEO of Check-Cap. “We believe that 2017 promises to be a pivotal year for Check-Cap. In addition to submitting for a CE Mark, we plan to initiate a pilot trial in the U.S. in the second half of this year. Recently, we held our first pre-submission meeting with the U.S. Food and Drug Administration and were encouraged by our initial discussions with the Agency.”
Mr. Densel added, “A robust body of data has shown that screening can reduce mortality by detecting precancerous polyps and early stage CRC. However, individuals have clear preferences, determined by test characteristics, which influence the uptake of existing screening options. We are dedicated to achieving accurate polyp detection, comfort and convenience in a single test, and are committed to developing C-Scan as an option to increase screening rates.”
Source: PR Newswire