Businessweek

Given Imaging Ltd. develops, manufactures, and markets diagnostic products for the visualization and detection of disorders of the gastrointestinal tract. Products Capsule Endoscopy The company’s principal product, which incorporates its core technology, is the Given System, a proprietary wireless imaging system that uses its disposable video capsules (the PillCam capsules). The Given System consists of three components: PillCam Capsules: The PillCam capsules are miniaturized disposable color video cameras encased in a plastic shell, incorporating one or more specially developed imaging devices based on complementary metal oxide semiconductor (CMOS) technology. Other components include optics, white-light emitting diodes for illumination, an application-specific integrated circuit device for control and image transmission, high-capacity silver oxide batteries, an antenna and other discrete electronic components. The company is selling the following PillCam capsules: PillCam SB — The PillCam SB video capsule is used for visualization and detection of abnormalities of the small bowel in patients ages two years and older. The PillCam SB capsule measures 11mm by 26mm (approximately 0.43 by 1.02 inches) and transmits images at a rate of 2 images per second, generally for 8 hours or more, resulting in approximately 50,000 images, at which time the operation of the capsule stops and recording ceases. After ingesting the capsule at the physician’s office, the patient can continue daily routine as the capsule transmits the images to a portable data recorder, which is later returned to the physician’s office for review and diagnosis. PillCam ESO — The PillCam ESO capsule is used to visualize the esophageal mucosa. The PillCam ESO capsule is similar in size to the PillCam SB capsule and contains an imaging device and light source at both ends of the capsule. The procedure with PillCam ESO is short and is done entirely within the physician’s office. In 2011, the company received the United States Food and Drug Administration (FDA) clearance to market and sell PillCam ESO 3, the third generation of this capsule, which incorporates various latest features of its PillCam capsule technology. The PillCam ESO 3 capsule enables physicians to visualize the esophagus with improved confidence. PillCam COLON — PillCam COLON is the third video capsule the company has developed. PillCam COLON capsule measures 11 mm by 31 mm (approximately 0.43 by 1.29 inches), slightly larger than the PillCam SB and PillCam ESO capsules. It contains an imaging device and light source at both ends of the capsule. PillCam COLON is complementary to traditional colonoscopy and an appropriate exam for those patients who have received incomplete colonoscopy, are contraindicated for colonoscopy or are unwilling to undergo traditional colonoscopy. The platform for PillCam COLON includes some of the same elements as PillCam SB and PillCam ESO, including a sensor array and data recorder. Similar to other methods of colon visualization, the PillCam COLON capsule procedure includes a colon cleansing and preparation procedure, as well as additional cleansing agents to improve capsule propulsion. PillCam COLON 2 utilizes bi-directional communication which enables real-time adjustments to maximize colon tissue coverage. Agile Patency System — The Agile patency system consists of the Agile patency capsule, a dissolvable capsule the same size as the PillCam SB capsule, with a radio frequency identification (RFID) tag packed in a lactose and barium powder. The Agile patency capsule is ingested by the patient and allows physicians to confirm free passage of a PillCam capsule in a patient’s gastrointestinal tract. The reusable component of the Agile patency system is a hand-held patency Scanner, which detects the signal from the RFID tag. Data Recorder, Sensor Array and SensorBelt After ingestion by the patient, the PillCam capsule transmits information from the body to a proprietary wireless data recorder. The data recorder is worn on a belt around the waist of the patient or hangs on a shoulder strap for the duration of the examination. The latest gen