Check-Cap (NASDAQ: CHEK) is a clinical-stage medical diagnostics company engaged in the development of an ingestible imaging capsule that utilizes low-dose X-rays for the screening of precancerous polyps and cancer. The company’s C-Scan® system provides an alternative to the current Colorectal Cancer (CRC) screenings, such as a colonoscopy, to help increase screening rates. Unlike a colonoscopy, Check-Cap’s system doesn’t require a bowel prep, which is a huge selling point for at-risk patients. Check-Cap recently enrolled the first patient in its multi-center study of the C-Scan® system in support of its plans to submit for a CE Mark in the first half of 2017. “Completing the optimization of our system and initiating the trial to support CE Marking is a very positive step forward in the development of a more patient-friendly alternative to today’s invasive and preparation-intensive approaches to CRC prevention,” Check-Cap CEO Bill Densel stated in an earlier press release. “We believe that 2017 promises to be a pivotal year for Check-Cap. In addition to submitting for a CE Mark, we plan to initiate a pilot trial in the U.S. in the second half of this year. Recently, we held our first pre-submission meeting with the U.S. Food and Drug Administration and were encouraged by our initial discussions with the Agency.” The American Cancer Society estimates that approximately 136,000 people are diagnosed with CRC in the U.S. annually, with roughly 50,000 people dying from the disease, making it the western world’s second largest cancer killer. With early screening, CRC is largely preventable and/or treatable.
To learn more, visit www.check-cap.com
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company developing the world’s first ingestible capsule system for preparation-free, minimally-invasive colorectal cancer screening. The capsule utilizes innovative ultra-low dose X-ray and wireless communication technologies to scan the inside of the colon as it moves naturally, while the patient follows his or her normal daily routine. After passage, the system generates a 3D map of the inner surface of the colon which enables detection of polyps and cancer. Designed to increase the willingness of individuals to participate in recommended colorectal cancer screening, the Check-Cap system addresses many frequently-cited barriers, including laxative bowel preparation, invasiveness, and sedation. The Check-Cap system is currently not cleared for marketing in any jurisdiction.
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