Colorectal cancer (CRC) has become a major healthcare concern. The life time risk of contracting CRC is estimated as 0.6%. More than 1 million new cases are diagnosed yearly worldwide.
CRC is the second leading cause of cancer death with an estimated yearly worldwide death toll of 510,000 people. CRC is preventable through early detection, chemo- prevention and change in life style and nutrition.
Currently, screening options for CRC include: fecal occult blood test (FOBT), flexible sigmoidoscopy, the combination of FOBT and flexible sigmoidoscopy, computerized tomographic colonography (CTC) and colonoscopy.
Current screening methods are a major barrier to the achievement of optimal early detection. Several new screening modalities, such as CTC (or virtual colonoscopy) and stool DNA testing have recently been developed.
Colonoscopy remains the gold standard for colorectal screening because it provides very high sensitivity (>90%) with a false negative rate of 6% for adenomas 1 cm. or more in diameter.
Legislation was passed in both the USA (2001) and Germany (2002) and more recently in Italy and France, to ensure healthcare provider coverage for screening colonoscopy for patients over the age of 50. As a result there is a dramatic increase in the number of colonoscopies performed and those in demand.
The present worldwide screening colonoscopy market is estimated at 15 million procedures per year, however, in light of reimbursement precedence for CRC screening is approved in more countries the market potential is estimated at 30-40 million procedures a year.
In a recent study published by investigators from the Center for Disease Control (CDC) it was reported that 14.2 million colonoscopies were performed in the USA in 2002 and half of those were screening colonoscopy procedures. In addition 2.8 million sigmoidoscopies were performed. The same investigators estimated that there are 42 million Americans over the age of 50 who have not been screened and that if colonoscopy will be used as the screening method it would take 10 years to screen the unscreened population. There are approximately 9,000 gastroenterologists who perform colonoscopy in the USA. It has recently been estimated that there is a need for 32,700 more gastroenterologists to meet market demand.
These figures underline the importance of a technology that could increase throughput significantly without compromising screening colonoscopy's sensitivity and specificity.
GI View believes that the Aer-O-Scope with its distinct potential advantages over standard colonoscopy uniquely positions it to capitalize on this market opportunity.
