Business Summary excerpt from SEC filing dated: April 7, 2006
We were incorporated by RDC Rafael Development Corporation under the laws of the State of Israel in January 1998. We are registered with the Israeli registrar of companies in Jerusalem. Our registration number is 51-257802-2. Our address is Hermon Building, New Industrial Park, Yoqneam 20692, Israel. Our telephone number is (011) 972-4-909-7777. Our agent in the United States is our subsidiary Given Imaging, Inc. Given Imaging, Inc.’s address is Oakbrook Technology Center, 5555 Oakbrook Parkway, No. 355, Norcross, GA 30093.
We develop, manufacture and market innovative diagnostic products for the visualization and detection of disorders of the gastrointestinal tract. We pioneered capsule endoscopy, a proprietary approach to visual examination of the gastrointestinal tract through the use of a miniaturized video camera contained in a ingestible disposable capsule. Our principal product, which incorporates our core technology, is the Given System, a proprietary wireless imaging system that uses our disposable video capsules, which we refer to as the PillCam capsules. The PillCam video capsules are easily ingested by the patient and move naturally through the gastrointestinal tract without discomfort while wirelessly transmitting to a portable recorder, enabling the gastroenterologists to view high quality video, images and data on our workstation, utilizing our proprietary RAPID software.
We believe that capsule endoscopy provides a patient-friendly solution that addresses a significant market opportunity and overcomes many of the shortcomings of traditional diagnostic tools for gastrointestinal disorders. In 2001, we commenced marketing the Given System, our capsule endoscopy platform, with the M2A capsule (which we rebranded in 2004 as the PillCam Small Bowel capsule, or PillCam SB), for detection of disorders of the small bowel. As of December 31, 2005, we had an installed base of more than 2,860 Given Systems and had sold more than 307,000 PillCam SB capsules in over 50 countries worldwide. In November 2004, we received FDA marketing clearance for our second PillCam capsule, the PillCam ESO capsule, for visualizing the esophagus. We market the PillCam ESO video capsule in the United States through a strategic marketing and sales alliance we formed in May 2004 with InScope, a division of Ethicon Endo-Surgery, a Johnson & Johnson company.
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We have also developed the AGILE Patency Capsule and system, which is a dissolvable capsule that enables physicians to determine whether there are obstructions or strictures in the gastrointestinal tract. We launched the AGILE Patency Capsule and system in Europe in November 2003. Following favorable clinical trial results for the AGILE Patency System in the United States, we submitted the AGILE Patency System for FDA clearance in December 2005 under a 510(k) application and we expect to receive FDA clearance to market this system in the United States in the first half of 2006.
Our long-term objective, subject to further development and receipt of regulatory clearances and/or approvals, is to establish the Given System as a platform for diagnosis of disorders in all parts of the gastrointestinal tract and the PillCam capsules as the first tool administered to patients with such suspected disorders. We believe that each segment of the gastrointestinal tract presents meaningful opportunities for patient-friendly diagnostic procedures. In furtherance of these objectives, in December 2005, we launched a further advanced version of our RAPID software, RAPID 4.0, which supports and is compatible with the entire line of PillCam capsules currently available and is expected to significantly improve physician productivity. In addition, in 2005 we made significant progress in the development of PillCam Colon for diagnosis of disorders in the colon and began initial clinical trials with this capsule. If clinical trials results are positive, we intend to submit the PillCam Colon capsule for FDA clearance and launch it in Europe during 2006. In 2005, we also saw the first third-party payors changing their reimbursement policies to cover PillCam SB as a first line diagnostic tool that may be administered to a patient without first undergoing other tests, such as upper or lower endoscopy.
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