Check-Cap Ltd. (Nasdaq: : CHEK) (NASDAQ: CHEKW), (NASDAQ: CHEKZ), which is developing a preparation-free ingestible scanning capsule-based system for the detection of precancerous polyps called C-Scan, has announced positive results from its pilot study of the system in the U.S.
The study was designed to evaluate the safety, usability and subject compliance of the C-Scan System. It was at the NYU Grossman School of Medicine and Mayo Clinic, Rochester. The primary endpoint of the study was to evaluate the incidence of device or procedure related serious adverse events. Secondary endpoints included patient compliance, subject satisfaction and device and procedure related performance. Because of the sample size, the study was not designed to be powered for statistical significance.
No device or procedure related serious adverse events (SAEs) were reported and all device or procedure related adverse events were mild in severity. In total, 45 patients enrolled in the study, or whom 28 were evaluable after factoring in technical and physiological dropouts and protocol violations. Analysis of the evaluable patient results revealed agreement between C-Scan and colonoscopy in detection of polyps, consistent with data from the post-CE approval study.
"The results of the study are promising, both in terms of safety and patient compliance of the procedure," said Seth A. Gross, M.D., principal investigator of the study, gastroenterologist and associate professor of medicine at NYU Langone Health. "Most non-invasive colorectal cancer screening options currently available have modest efficacy detecting pre-cancerous polyps. We are excited about the potential of the C-Scan System offering a patient-friendly screening option that could detect pre-cancerous polyps before they become malignant, and we look forward to seeing the C-Scan System advancing into the US pivotal study in the future."
Check-Cap CEO Alex Ovadia said, "Completing our first study in the US constitutes an important milestone for our company as we work towards the initiation of a US pivotal study in late 2020. We are now focused on preparing our IDE submission to the FDA and collecting additional clinical data utilizing a new version of our C-Scan System, while at the same time continuing to build out our global operational infrastructure. We believe 2020 will be a meaningful year for Check-Cap."
Check-Cap has a market cap of $14 million. Its share price is currently down about 2.5%.
Published by Globes, Israel business news - en.globes.co.il - on December 30, 2019
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