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Check-Cap Initiates U.S. Pilot Study of C-Scan® for Colorectal Cancer Screening
ISFIYA, Israel, April 8, 2019 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical-stage
About this update from Check-cap Ltd.
[{"type":"text","content":" ISFIYA, Israel, April 8, 2019 /PRNewswire/ -- Check-Cap Ltd. (the \"Company\" or \"Check-Cap\") (NASDAQ: CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), a clinical-stage medical diagnostics company advancing the development of C-Scan®, the first and only preparation-free ingestible capsule for the prevention of colorectal cancer through the detection of precancerous polyps, today announced the initiation of its U.S. pilot study of the C-Scan® system, following Institutional Review Board (IRB) approval and full Investigational Device Exemption (IDE) application approval by the U.S. Food and Drug Administration (FDA). The first patients have ingested the C-Scan® capsule at the New York University School of Medicine. \n\n \n\"The pilot study initiation is a critical milestone on our path for developing and potentially commercializing the C-Scan® system in the U.S.,\" said Alex Ovadia, chief executive officer of Check-Cap. \"We have also provided the FDA with the additional required information that allowed us to be granted with the full approval of the IDE. We look forward to sharing the results of the study in the near future as we truly believe that our patient-friendly scanning capsule can redefine the colorectal cancer screening landscape and decrease the overall incidence of this highly-preventable disease.\"\n\"We are pleased to participate in this pilot study of C-Scan®, a preparation-free capsule-based system for the prevention of colorectal cancer being tested in the U.S.,\" noted Seth A. Gross MD, gastroenterologist and Associate Professor of Medicine, NYU Langone Health. \"Unfortunately, colorectal cancer remains the second-leading cause of cancer death in the U.S. But we know that with the utilization of colorectal cancer screening, we can reduce the incidence and mortality rates related to this disease. The potential addition of a new screening option that is capsule-based and does not require a bowel prep offers the promise of increasing our screening rates. We are looking to the results of this study and the potential for an effective new screening option for the prevention and early detection of colorectal cancer.\"\nThe single-arm pilot study (NCT03735407) will enroll up to 45 subjects considered to be of average risk for polyps and colon cancer. The study is evaluating the safety, usability and subject compliance of the ...