ISFIYA, Israel--(EON: Enhanced Online News)--Check-Cap, Ltd., developer of the world’s first preparation-free, non-invasive, high-resolution colon imaging system, announces clinical proof-of-concept showing that the Check-Cap imaging system safely reconstructs high-resolution 3-dimensional images of the colon using an ingestible capsule and a proprietary ultra-low-dose X-ray-based imaging technology. The Check-Cap imaging system is being developed as a screening modality for colorectal cancer and clinically significant pre-cancerous polyps, and is the first high-resolution system that requires no cleansing or other aggressive bowel preparation.
“Colorectal cancer is the most deadly of the preventable cancers”
More than 1 million new cases of colorectal cancer are reported each year worldwide, according to the World Cancer Research Fund International. The World Health Organization attributes more than 600,000 deaths annually to this cancer, which is the second leading cause of cancer-related deaths in the western world. Invasive colonoscopy, considered the gold standard for colorectal screening, like all current forms of high-sensitivity procedures requires thorough cleansing of the colon, which many patients find as the most burdensome aspect of colon cancer screening.
“Colorectal cancer is the most deadly of the preventable cancers,” said Check-Cap CEO Guy Neev. “About 90% of such cancers are deemed preventable or curable with early screening and detection, yet current screening methods are not well received. Many colonoscopy candidates avoid the procedure because of the discomfort of laxatives, fasting and tube insertion, and the possibility of pain and embarrassment. Currently approved optic-based capsules also require aggressive bowel cleansing. In fact, fewer than 30% of Europeans and 50% of Americans in the populations recommended for screening actually undergo screening procedures. Non-compliance is extremely high given our estimate that in the U.S., Europe and Japan each year 36 million people fall within the 50 to 75 year-old target age group for screening, assuming one screening every 10 years.
“The Check-Cap imaging system is intended to provide a patient-friendly solution for high-resolution screening that detects clinically significant polyps and colorectal cancer with accuracy comparable to an invasive colonoscopy. Presuming a comparable detection rate, we expect that only about 15-20% of those screened with the Check-Cap imaging system will be subsequently referred for a therapeutic colonoscopy,” he added. “Quite simply early detection leads to early treatment, and early treatment saves lives. We are optimistic that the Check-Cap imaging system will become the standard of care for first-line colon cancer screening and look forward to continuing the clinical development of this product.”
The Check-Cap imaging system consists of an ingestible capsule that transmits colon section measurements through a radio frequency (RF) link to a data recorder. The single-use, disposable capsule is approximately 34 millimeters long and 11.5 millimeters wide, making it similar in size to other capsule endoscopy products. It advances through the body by natural motility, painlessly capturing and continuously transmitting data reflecting the colon’s internal surface with the help of a contrast agent before being excreted naturally within two to three days. Patients are able to continue their normal daily routines throughout the process including normal food intake. Upon test completion, gastroenterologists or radiologists can analyze the data from any computer in less than 10 minutes.
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 Tel Aviv Medical Center in Israel. The study demonstrated the applicability of the novel imaging technology to the human colon, generating images taken in the colon without any prior bowl-cleansing. All subjects ingested the capsules easily with smooth passage within the designated transit time. There were no reported device-related adverse events, irregular symptoms of pain or discomfort, or significant changes in bowel habits after ingestion. Only mild effects on bowel movements were noted, which were determined to be related to the contrast agent. Subjects reported some discomfort during sleep due mainly to the connection of laptop computers that were used to monitor the patients and gather images. The next-generation Check-Cap imaging system employs a wireless, portable data collection recorder worn by the patient on a disposable patch.
“This technology has successfully demonstrated the ability to image the preparation-free human colon at ultra-low-dose radiation exposure,” said Prof. Nadir Arber, Head of the Integrated Cancer Prevention Center, Tel Aviv Sourasky Medical Center and principal investigator of the study. “Once sensitivity and specificity are demonstrated, the Check-Cap imaging system holds strong potential to have a meaningful impact on colon screening.”
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 Europe and expects to submit a request for CE mark toward the end of 2014. A pivotal study in the U.S. is planned for early 2015. The company also intends to pursue regulatory approvals in Japan and China. Among other criteria, pivotal studies are expected to compare the images of polyps identified by the Check-Cap imaging system with the same polyps detected by traditional optical screening colonoscopy and CTC in instances where patients were referred after positive exam results. These clinical findings also will be analyzed against results obtained from FOBT and FIT.
“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.”
About Check-Cap Ltd.
Check-Cap is a medical device company focused on the development of gastrointestinal imaging devices. The company’s lead product is an endoscopy capsule that utilizes proprietary, ultra-low-energy X-ray-based measurement technology to safely generate high-resolution, 3-dimensional imagery of the colon without cleansing or other aggressive bowel preparation. This patient-friendly solution is designed to increase compliance with screening recommendations.
Founded in early 2005, Check-Cap recruited a team of world-class experts in physics, software engineering, electronics, mechanics and physiology to develop the Check-Cap multi-disciplinary imaging solution for imaging and screening of the colon. The company is led by a highly skilled, experienced team of managers and clinicians with a strong record in medical device ventures, and is advised by a well-respected scientific advisory team. The Check-Cap product has been granted patents in the U.S., Europe, Japan, China, India and Hong Kong, and additional patent applications have been submitted worldwide. The company has received funding from GE Healthcare, Pontifax Ventures, Counterpoint, Docor, Biomedix, Jacobs Investment, BXR Partners and Emigrant Savings Bank, among others.