Overview of Capsule Endoscopy Capsule endoscopy is a procedure designed to help your physician see what is happening inside parts of your gastrointestinal (GI) tract. The GI tract is the tube which extends from the mouth to the anus in which the movement of muscles digests food. During the procedure, a patient swallows a vitamin-sized pill with a camera inside. Transported smoothly and painlessly through the GI tract by the body’s own natural peristalsis, the PillCam® video capsule transmits images of different parts of your body such as the small intestine and the esophagus. Since the first PillCam video capsule was approved by the FDA in 2001, more than 500,000 patients have safely swallowed one of the PillCam video capsules. Capsule endoscopy is the least invasive and most direct way for doctor’s to see the entire small intestine and esophagus. Hundreds of clinical studies conducted by the world’s leading gastroenterologists have shown the value of the PillCam video capsules in helping doctors diagnose or rule out disorders of the GI tract. PillCam SB The PillCam SB video capsule measures 11 mm x 26 mm and weighs less than 4 grams. It contains an imaging device and light-source on one-side and transmits images at a rate of 2 images per second generating more than 50,000 pictures over an 8-hour period. PillCam SB was initially cleared by the U.S. Food and Drug Administration in 2001 and today is used by physicians to detect and diagnose disorders of the small intestine. This includes Crohn’s disease, small bowel tumors, malabsorption disorders (such as celiac disease), GI injuries induced by extended NSAID use and suspected GI bleeding of the small bowel. The Company’s next generation small bowel video capsule, PillCam SB2, was cleared for marketing by U.S. Food and Drug Administration in May 2007. It is the same size as the PillCam SB video capsule and offers advanced optics and a wider field of view to image the small intestine. PillCam SB2 also captures nearly twice the mucosal area per image. How the Procedure Works A patient fasts starting at midnight the day before the procedure. The following morning they arrive at the physician’s office where they are prepped for the procedure. This includes attaching the sensor array to the patient’s abdomen and the data recorder to a belt around the patient’s waist. Once these tasks have been completed the patient will be given a glass of water to help swallow the vitamin-sized pill. The patient can resume daily activities once he or she has successfully swallowed the PillCam video capsule. After 8-hours the patient returns to the physician’s office to return the device and the pill passes naturally with a bowel movement usually within 24 hours. Images are downloaded by the physician to the Given workstation for review and diagnosis. The proprietary RAPID software installed on the workstation contains an image atlas to help facilitate the analysis.