Check-Cap (NSDQ:CHEK) said today it won conditional approval from the FDA for its investigational device exemption application to launch a pilot study of its C-Scan system.
The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural information on the lumen of the colon to create 2D and 3D maps.
The conditional approval will require Check-Cap to provide additional information to the FDA, but will allow the company to being enrolling patients immediately once it has achieved approval from the study site’s Institutional Review Board.
“We are pleased to have received FDA approval of our IDE application, and we look forward to initiating our pilot study of the C-Scan system. This is a significant milestone for our company as we work to advance the clinical development of our novel technology in the U.S. As the first and only preparation-free capsule based screening method for colorectal cancer prevention through precancerous polyp detection, we believe C-Scan can significantly increase screening adherence, resulting in improved patient outcomes and significant savings to the healthcare system. We look forward to results from this first U.S. study,” CEO Alex Ovadia said in a press release.
The pilot trial will be a single-arm study looking to enroll patients considered to be of average risk for polyps and colon cancer, and will evaluate the safety, usability and subject compliance of the C-Scan system, the company said.
In September, Check-Cap released interim results from the post-CE Mark approval study of its C-Scan system version 3, touting the device’s ability to detect polyps in un-prepped colons.
