Check-Cap (NSDQ:CHEK) said its X-ray-enabled, colorectal cancer-screening capsule will have a pilot study in the United States.
The Isfiya, Israel-based startup makes the C-Scan System, an ingestible capsule used to detect precancerous polyps without the need for laxatives or an invasive procedure. The C-Scan system 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 inner lining of the colon. It received approval from Israel’s Ministry of Health Medical Device division (AMAR) and the CE Mark in 2018.
New York University School of Medicine’s Institutional Review Board (IRB) recently approved the technology for a single-arm pilot study enrolling up to 45 subjects considered to be of average risk for polyps and colon cancer. FDA had given Check-Cap a conditional investigational device exemption in December to seek a U.S. pilot study.
“We are excited to receive IRB approval as this important milestone enables Check-Cap to bring the C-Scan system into the clinic in the U.S.,” said Check-Cap CEO Alex Ovadia in a prepared statement. “Following the CE Mark clearance and approval to initiate commercial sales of the C-Scan system in Israel last year, IRB approval is a critical step toward developing clear paths to commercialization in major markets worldwide. We look forward to the initiation of the pilot study evaluating our patient-friendly screening method for colorectal cancer as we aim to increase screening adherence and ultimately decrease the overall incidence for this highly-preventable disease.”
