Check-Cap Announces Publication of Peer-Reviewed Article Highlighting Safety and Patient Satisfaction Data for Its Colorectal Screening Test, C-Scan®
ISFIYA, Israel, November 22, 2021 /PRNewswire/ — Check-Cap Ltd. (the “Company” or “Check-Cap”) (NASDAQ:CHEK), (NASDAQ:CHEKZ), a clinical-stage medical diagnostics company advancing the development of C-Scan®, the first and only user-friendly system for the patient, without preparation screening test to detect polyps before they turn into colorectal cancer (CRC), today announced the publication of a research titled “Detection of Colorectal Cancer and Polyps Using a New No-Prep Colon Scanner Capsule: A Pilot Study of Patient Safety and Satisfactionin the peer-reviewed journal Digestive Diseases and Sciences, which further validates C-Scan safety and patient satisfaction based on data from its previously completed 2019 U.S. pilot study.
In this study, there were no serious adverse events or cases of capsule retention among the 40 patients who underwent the study procedure. Among the 87% of patients who completed the satisfaction questionnaires, significantly more patients recommended the C-Scan capsule, with an average score of 4.1 out of 5 compared to a score of 2.8 out of 5 for colonoscopy ( p=0.001).
“Screening for the detection of precancerous colorectal polyps is a key approach to cancer prevention. Yet a known barrier for some patients is the bowel cleansing required for colonoscopy and the invasiveness of the procedure. Less invasive alternatives are needed to engage a percentage of the population who avoid regular screening,” said Seth A. GrossMD, the study’s principal investigator, gastroenterologist and associate professor of medicine at NYU Langone Health.
Elizabeth RajanMD, Study Principal Investigator, Gastroenterologist and Professor of Medicine, Mayo Clinic, Rochester, said: “Our prospective single-arm pilot study demonstrated positive safety results and high patient satisfaction with A unique novel no-prep colon capsule system for the detection of colorectal polyps and masses.This study represents a step towards a no-prep approach to CRC screening that could overcome one of the major barriers to screening. multi-center pivotal study is planned in the United States to further validate the performance of this technology.”
Alex OvadiaCEO of Check-Cap, said, “We continue to make progress in preparation for the launch of our next pivotal study in the United States, to further validate the performance, safety and accuracy of polyp detection using from C-Scan. We look forward to making this disruptive screening modality available to the many patients who need user-friendly screening tests. »
The Check-Cap US Pilot Study was a prospective, open-label, single-arm study that examined C-Scan safety, usability, and subject compliance and assessed patient satisfaction with colonoscopy. The study was conducted at two US sites, NYU Grossman School of Medicine and the Mayo Clinic in Rochester in 2019. 80% of patients had an average risk of colorectal cancer, and the average age was 52.9 years. Each patient ingested a C-Scan capsule and underwent a comparative colonoscopy, which was performed by an independent gastroenterologist who was not informed of the corresponding test results.
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company that aims to redefine colorectal cancer (CRC) screening with the introduction of C-Scan®, the first and only patient-friendly prep-free screening test to detect polyps before they turn into colorectal cancer and enable early intervention and cancer prevention. The Company’s disruptive capsule-based screening technology aims to dramatically increase screening uptake worldwide and help millions of people stay healthy through preventative CRC screening. C-Scan uses an ultra-low dose X-ray capsule, an integrated positioning, monitoring and recording system, and proprietary software to generate a 3D map of the inner wall of the colon as it moves naturally along the gastrointestinal tract. The C-Scan is non-invasive and requires no sedation. Unlike other capsule technologies, it requires no bowel preparation, allowing patients to continue with their daily routine without interruption. The C-Scan is not intended to replace colonoscopy. A positive C-Scan result should be followed by a colonoscopy.
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Investor contacts
Irina Köffler
LifeSci Advisors, LLC
646.970.4681
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Meirav Gomeh Bauer
LifeSci Advisors, LLC
+972(0)-54-476-4979
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SOURCE Check-Cap Ltd.
