Given Imaging Announces Marketing Clearance for 14 Frame PillCam ESO Video Capsule for the Esophagus
Monday November 29, 4:08 am ET
YOQNEAM, Israel--(BUSINESS WIRE)--Nov. 29, 2004--Given Imaging (Nasdaq: GIVN - News), the global leader in capsule endoscopy, today announced that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the 14 frame PillCam(TM) ESO video capsule for visualization of the esophageal mucosa together with the new RAPID 3 software that includes numerous features and enhancements.
Given Imaging will immediately begin marketing and selling the new RAPID3 software, upgrading eligible customers , and delivering PillCam ESO to market.
With this FDA clearance, Given Imaging will receive the first milestone payment from Ethicon Endo-Surgery amounting to $10 million . This amount will be recorded on a straight line over the 15 year life of the agreement as a reduction in marketing expenses.
About Given Imaging
Given Imaging is redefining gastrointestinal diagnosis by developing, producing and marketing innovative, patient-friendly products for detecting gastrointestinal disorders. The company is developing a complete line of PillCam video capsules for detecting disorders throughout the gastrointestinal tract. The company's technology platform is the Given® Diagnostic System, featuring the PillCam(TM) video capsule, a disposable, miniature video camera contained in a capsule, which is ingested by the patient. The PillCam(TM) SB video capsule is the only naturally ingested method for direct visualization of the entire small intestine. It is currently marketed in the United States and in more than 60 other countries and has benefited more than 145,000 patients worldwide. The PillCam(TM) ESO video capsule, which provides visual examination of the esophagus, has been cleared for marketing by the FDA. Additional capsules for visualization of the stomach and colon are under development. Given Imaging's headquarters, manufacturing and R&D facilities are located in Yoqneam, Israel; it has direct sales and marketing operations in the United States, Germany and France, and local offices in Tokyo, Madrid and Sydney. For more information, visit givenimaging.com. |
