The Check-Cap imaging system requires no fasting or prior bowel cleansing as the imaging capsule employs X-rays for colon section measurements. The X-rays are ultra-low dose (with radiation exposure approximating that of a single chest X-ray) and allow for 3- dimensional imaging of the lining of the colon even when the capsule is surrounded by intestinal content. The ability to transmit a full 360-degree radius around the capsule is expected to allow for the detection of polyps including those located behind colon folds.
Clinical proof-of-concept indicating the procedure is safe and feasible was based on a 10-subject study conducted at
"This technology has successfully demonstrated the ability to image the preparation-free human colon at ultra-low-dose radiation exposure," said Prof.
Clinical proof-of-concept is the first part of a broader clinical feasibility study to establish the safety and preliminary efficacy of the Check-Cap imaging system by comparing results with those from non-invasive, low-sensitivity fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) as well as from optical colonoscopy. The feasibility study also evaluates the capsule's total and segmental transit time and analyzes the effects of the presence of polyps and variable colon dimensions. The company is developing an atlas of polyp images that will enable comparisons between images acquired by different modalities. It also is collecting data about the overall imaging of the colon's internal surfaces to support the development of a correlation map of polyps identified by the Check-Cap imaging system with polyps imaged by optical colonoscopy and computed tomographic colonography (CTC). Additionally, the study measures total radiation exposure and the distribution of contrast material within the colon.
Following the success of the clinical proof of concept, Check- Cap plans to expand its clinical program by launching a pivotal study in
"Given past approvals of other optic-based colon screening systems, we believe the regulatory pathway for the Check-Cap imaging system in major markets worldwide is well established," added Neev. "We will be working toward securing private- and public-sector reimbursement with the advantage that the Check-Cap imaging system does not require hospitalization or loss of day work and thus will be less expensive than a traditional colonoscopy. It will be an attractive screening alternative for many who currently are not compliant with the colorectal cancer screening guidelines. In parallel, we are developing go-to-market strategies to support commercial success."
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