Check-Cap Announces IDE Submission to FDA for its C-Scan® System
If Approved, U.S. Pilot Study Anticipated to Commence in 4Q 2018
ISFIYA, Israel, October 9, 2018 - Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ: CHEK, CHEKW, CHEKZ), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, a preparation free screening method for the prevention of colorectal cancer through the detection of precancerous polyps, today announced that it has submitted an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) to advance studies of C-Scan®. If approved, the Company plans to initiate a U.S. pilot study during the fourth quarter of 2018.
Alex Ovadia, Chief Executive Officer of Check-Cap, commented: “We are pleased to announce IDE submission for our C-Scan® System. More than 700,000 deaths occur every year as a result of colorectal cancer and more than 1.3 million new colorectal cancer incidents are identified each year. Despite evidence that colorectal cancer screening can reduce associated mortality, adherence remains low due to the required preparation, invasiveness, and limited access in some communities to the current screening methods. We look forward to completing our U.S. regulatory path approval process, commencing our U.S. pilot study later this year, and eventually bringing the C-Scan® System to people in need. This schedule aligns with our near-term goals for the remainder of 2018, as we continue to execute on our clinical and commercial plans toward 2019.”
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, an ingestible capsule-based device for preparation-free colorectal cancer screening.
Utilizing innovative ultra-low dose X-ray and wireless communication technologies, the capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities. Designed to improve the patient experience and increase the willingness of individuals to participate in recommended colorectal cancer screening, C-Scan removes many frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation.
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