We anticipate that the FDA approval for the pivotal study will be subject to our providing sufficient clinical data from the multi-center, prospective clinical feasibility study. We also intend to pursue clinical trials for regulatory approvals in Japan and China in parallel to the U.S. pivotal study. Pivotal studies are expected, among other things, to compare the images of polyps identified by our imaging system with the same polyps detected by traditional optical colonoscopy and CTC in instances where patients were referred after positive exam results.

These clinical findings will be analyzed in comparison with results obtained from FOBTs and FITs. Subject to the successful completion of our clinical trials and the receipt of initial FDA approval for the marketing of our imaging capsule in the United States, our goal is to launch our product commercially in the United States during 2017.


DOTmed News: On March 31st, the last day of Colon Cancer Awareness Month, you rang the closing bell at NASDAQ. How can medical professionals get through to the general public about the importance of cancer screening?

GN: I find it very symbolic that Check-Cap was chosen to close the trade in NASADQ on the last day of Colon Cancer Awareness Month. Colorectal cancer screening saves lives. It is one of only a few cancers that can be prevented through screening. The risk of developing colorectal cancer increases with advancing age. More than 90 percent of cases occur in people aged 50 or older.

Building awareness is the most important part of helping to increase screening and decrease mortality rates. Colorectal cancer, second only to lung cancer as the leading cause of cancer deaths in the United States, effects men and women equally. Yet few Americans know that colorectal cancer can be prevented — not just detected. Colorectal cancer arises from pre-cancerous growths or polyps that grow in the colon, which, when detected early, can be removed, halting their progression to colorectal cancer. Under-use of proven screening tests – especially among Medicare beneficiaries: 1 in 3 adults – almost 23 million Americans between 50 and 75 years old – is not getting tested for colorectal cancer as recommended. The key is education and the emphasis on the fact that we aren't looking only for cancer but rather for pre-cancerous polyps, which, when removed, could prevent cancer.

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