The Clinical Need
Colon cancer is the Western world's second largest cancer killer, despite being 90% curable with early detection.
In the US alone, it is estimated that nearly 150,000 men and women are diagnosed with CRC annually, with 50,000 dying from this disease1. Worldwide figures include 1 Million new cases and more than 500,000 deaths. The disease claims more victims than breast cancer and AIDS combined.
Most of these deaths are preventable2 with screening and treatments.
Colonoscopy remains the gold standard for colorectal screening, providing very high sensitivity (>90%) with a false negative rate of 6% for adenomas 1 cm. or more. Thanks to increased awareness and broader insurance coverage, the number of colonoscopies performed has dramatically increased in the past few years. However, many patients still avoid screening due to colonoscopy's invasiveness, discomfort and perceived risks, with bowl prep being a significant drawback. Moreover, in some European countries, FOBT (and not Colonoscopy) is still the first mass screening tool dictated by health officials due to its low cost and simplicity. In these countries, colonoscopy compliance rates are therefore even much lower.
While the present worldwide screening colonoscopy market is estimated at 15 million procedures per year, the market potential is estimated at 30-40 million. According to a study by the Center for Disease Control (CDC), 14.2 million colonoscopies were performed in the USA in 2002, half of which were screening colonoscopies. The same study showed that 42 million Americans over the age of 50 have not been screened, and that it would take 10 years to screen the unscreened population with colonoscopies. With 9,000 gastroenterologists performing colonoscopies in the USA, it's been estimated that 32,700 more GIs would be needed to meet market demand.
These figures underline the importance of a technology that could increase compliance and throughput significantly, without compromising screening accuracy.
Check-Cap's advanced X-ray Radar technology is uniquely positioned to capitalize on this market opportunity:
1. Non-invasive and prep-free - patients will have no reason to avoid it.
2. Accurate - doctors and patients will trust it.
3. 'Self-administered' and simple - will enable screening of a larger population, freeing up resources and GIs' time to perform more therapeutic colonoscopies for the actual removal of polyps.
About 90% of tested population will not be required to undergo additional procedures until their next Check-Cap screening in 5 years, about 10% will be referred to a therapeutic colonoscopy.
1.Source: Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology.
2.CRC's Prevention: CRC can largely be prevented by the early detection and removal of adenomatous polyps, and survival is significantly better when CRC is diagnosed while still localized. It is evident that incidence and mortality reductions could be achieved if a greater proportion of adults over age 50 received regular screening. Although prospective randomized trials and observational studies have demonstrated mortality reductions associated with early detection and removal of polyps, many US adults are not receiving regular screening or have never been screened at all.
3.CRC's survival rates: Five-year survival is 90% if the disease is diagnosed while still localized but only 68% for regional disease and only 10% if distant metastases are present. (Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008: A Joint Guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal Cancer, and the American College of Radiology).
