Israeli clinical-stage medical diagnostics company Check-Cap (Nasdaq: CHEK) has announced that the US Food and Drug Administration (FDA) has conditionally approved the company's Investigational Device Exemption (IDE) application to initiate a US pilot study of the C-Scan system. C-Scan is the first and only preparation free capsule-based screening method for the prevention of colorectal cancer, through the detection of precancerous polyps,
The FDA's conditional approval of the IDE requires Check-Cap to provide additional information to the FDA and Check-Cap may begin enrolling patients immediately upon approval by the study site's Institutional Review Board (IRB).
Check-Cap CEO Alex Ovadia said, "This is a significant milestone for our company as we work to advance the clinical development of our novel technology in the US. 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 US study."
The US pilot study will be a single-arm study enrolling subjects considered to be of average risk for polyps and colon cancer. The study will evaluate the safety, usability, and subject compliance of the C-Scan system.
Published by Globes, Israel business news - en.globes.co.il - on December 14, 2018
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