Check-Cap Announces Presentation of Clinical Data Demonstrating Safety and Detection of Polyps Using Preparation-Free Colorectal Cancer Screening Capsule

ISFIYA, Israel, Oct. 18, 2016

During ACG, a video abstract entitled "A Preparation-Free X-Ray Imaging Capsule for Colon Cancer Screening" presented case studies on the use of the system in three patients enrolled in the Company's ongoing clinical feasibility study. Clinical review showed the system's viewing modes to examine the inner surface of colon segments in order to identify and locate flat sessile and pedunculated polyps that were confirmed by optical colonoscopy.

"Although colorectal cancer is the second leading cause of cancer deaths in the U.S., rigorous evidence suggests that better screening adherence can lead to significantly improved survival rates," said study presenter Seth A. Gross, M.D., Associate Professor and Chief of Gastroenterology at Tisch Hospital, NYU Langone Medical Center. "These data reinforce previous findings that a non-invasive, preparation-free alternative to traditional optical colonoscopy may be a safe and effective alternative for the significant portion of the population who do not currently undergo routine screening evaluation."

A poster presentation at UEGW entitled "A Novel Preparation-Free X-Ray Imaging Capsule for Colon Cancer Screening: Correlation between Capsule and Colonoscopic Clinical Findings" provided an update on preliminary data from the Company's ongoing clinical feasibility study evaluating the Check-Cap system in 66 volunteers aged 41-74 years. The study tracked the entire passage of the capsule through the alimentary tract using radio frequency telemetry and Check-Cap's proprietary capsule position tracking system. Findings from the study demonstrated the capability of the system to identify polyps and provide segmental location and morphology information, as confirmed by colonoscopy. All capsules were swallowed naturally without adverse events and excreted after an average transit time of 62 hours. Enrolled subjects were exposed to ultra-low doses of radiation with an average total exposure of 0.06 ± 0.04 mSv. While colonic polyps were clearly identified and reconstructed by the system, the efficacy of this colon screening modality will be further evaluated in planned multi-center studies.

Check-Cap anticipates submitting data from this study for CE Marking in the first half of 2017 and initiating a U.S. pivotal trial in 2018.

"While the benefits of colorectal cancer screening are well documented in clinical literature and re-enforced in screening guidelines, there are several significant barriers, including resistance to bowel preparation, that continue to deter many of the average-risk population," said Bill Densel, CEO of Check-Cap. "We are developing the Check-Cap system to offer an alternative modality that may help increase screening rates by addressing the perceived drawbacks of existing methodologies that may serve as obstacles to screening for a significant segment of the population."

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