Check-Cap Ltd. (the "Company" or "Check-Cap") (NASDAQ: CHEK, CHEKW), a clinical stage
medical diagnostics company developing a capsule-based system for preparation-free,
colorectal cancer (CRC) screening, today announced the enrollment of the first patient in
its multi-center study of the C-Scan(R) system in support of its CE Mark submission.
C-Scan employs proprietary, ultra-low-dose X-ray technology in an ingestible capsule
to create a 3D map of the inner colon to detect polyps, which may be, or may become,
cancerous. Unlike existing imaging modalities, Check-Cap's approach does not require bowel
preparation, which is a significant obstacle to screening. Designed to improve the patient
experience and maximize the number of people who complete screening, C-Scan works in
concert with the natural functioning of the colon, and does not require sedation or
changes to diet and normal daily activities.
"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,"
said Bill Densel, CEO of Check-Cap. "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 current multi-center, prospective trial, designed to demonstrate the safety and
clinical performance of C-Scan, will evaluate polyp detection as compared to colonoscopy.
Check-Cap expects to submit for a CE Mark in the first half of 2017.
Mr. Densel added, "A robust body of data has shown that screening can reduce mortality
by detecting precancerous polyps and early stage CRC. However, individuals have clear
preferences, determined by test characteristics, which influence the uptake of existing
screening options. We are dedicated to achieving accurate polyp detection, comfort and
convenience in a single test, and are committed to developing C-Scan as an option to
increase screening rates."
Check-Cap is a clinical-stage medical diagnostics company developing C-Scan(R), the
first capsule-based system for preparation-free, colorectal cancer screening.
Utilizing innovative ultra-low dose X-ray and wireless communication technologies, the
capsule generates information on the contours of the inside of the colon as it passes
naturally. This information is used to create a 3D map of the colon, which allows
physicians to look for polyps and other abnormalities. Designed to improve the patient
experience and increase the willingness of individuals to participate in recommended
colorectal cancer screening, C-Scan removes many frequently-cited barriers, such as
laxative bowel preparation, invasiveness and sedation The Check-Cap system is currently
not cleared for marketing in any jurisdiction.
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