Check-Cap Receives Approval From the Israeli Ministry of Health to Initiate Commercial Sales in Israel of its C-Scan® System
ISFIYA, Israel, Sept. 5, 2018 /PRNewswire/ -- Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW) (NASDAQ: CHEKZ), a clinical-stage medical diagnostics company engaged in the development of C-Scan®, an ingestible capsule for preparation-free, colorectal cancer (CRC) screening, today announced it has received approval from the Israeli Ministry of Health, the Medical Device Division (known as "AMAR"), to initiate commercial sales in Israel of the C-Scan system that received CE Mark approval in January 2018.
Alex Ovadia, Chief Executive Officer of Check-Cap, commented, "We are excited to receive approval from the Israeli Ministry of Health to initiate commercial sales in Israel of our C-Scan system. We believe that this approval reinforces the potential of the C-Scan system to increase CRC screening adherence and precancerous detection to ultimately reduce mortality by offering a preparation free, non-invasive and patient-friendly CRC screening option. We look forward to achieving our near-term planned milestones, which include commercializing the C-Scan system in Israel in the second quarter of 2019, pending extension of the AMAR approval and subject to engaging with a strategic partner and sufficient available capital."
The indication of use for the C-Scan system as provided in the AMAR approval are as follows: "The C-Scan system is intended to provide structural information on the endoluminal surface of the colon. It may be used to screen for colonic suspicious findings in adults at average-risk for CRC who are not candidates for colonoscopy or who decline colonoscopy."
The AMAR approval is valid until February 28, 2019 and its extension is subject to certain conditions detailed in the AMAR approval and the requirements of the Israeli Ministry of Health.
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan®, an ingestible capsule- 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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SOURCE Check-Cap Ltd.