FDA clearance for new blood collection system

FDA clearance for new blood collection system Stockholm, Sweden - Gambro AB (Stockholm Stock Exchange: GAMBaST, GAMBbST), a leading international healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has cleared for sale the COBE Trima Automated Blood Component Collection System, an alternative to whole blood collections. The Trima System is the first device to allow blood centers to collect combinations of red blood cells, platelets, and plasma simultaneously from a single blood donor. Introduced in Europe in October 1997, the COBE Trima System is now being used successfully in the United States as in other parts of the world. Automated Blood Collection (ABC) is a new concept developed by the blood collection industry to solve a trio of problems facing blood centers today: increased manufacturing costs, increased government regulation, and a shrinking pool of blood donors. The COBE Trima System is a next generation collection system designed to put advanced manufacturing tools in the hands of community blood centers. The Trima System uniquely allows blood centers to collect combinations of red blood cells, platelets, and plasma from a single donation, yielding more transfusable products per donation than conventional whole blood collection. It also allows blood centers to provide their customers the quantities and combinations of transfusion doses of blood products they need in a timely manner based on individual patient needs. Said COBE BCT President Edward C. Wood, "We've designed the COBE Trima System such that a blood center can fulfill its blood collection needs with 25% fewer donations, thereby reducing costs and continuing to improve the safety of the nation's blood supply." In a presentation at the 1998 American Society for Apheresis conference, the Blood Transfusion Center in Leuven, Belgium, reported that of its whole blood donors who donated on the Trima System, 96% stated they would continue to make ABC donations. Experience in Europe, Australia, and the United States demonstrates that ABC quickly gains acceptance among whole blood donors once they understand the greater benefits their donation can bring to patients. "We're very pleased with the operation of the Trima System and we're confident that over the long-term it will provide us with a level of operational efficiency superior to any other system on the market," said Michael Fuller, Chief Operating Officer of Sacramento Medical Foundation Blood Centers, which has had six Trima Systems in place since December 1998. Community Blood Centers of South Florida is the first blood collection agency in the world to implement the Trima System in a mobile unit. Its first blood drive using the system begins in February in the Florida Keys. "With the Trima System, we anticipate getting the maximum number of products to a depot in a timely manner," said Dawn Brown, Director of Donor Resources. "Automated Blood Collection is the way of the future. It's as simple as that." Lakewood, Colorado-based COBE BCT is a world leader in blood cell processing products. It is a wholly owned subsidiary of Gambro Group AB, the world's largest manufacturer of hemodialysis products. For further information please contact: Edward C. Wood, President COBE BCT, Inc., tel. +1-303-232-6800 Bengt Modéer, Senior Vice President, Corporate Communications, tel. +46-8-613 65 00, +46-70-513 65 33 Gambro is a global healthcare company with leading positions in renal care - services and products - and blood component technology (BCT). Gambro is the second largest provider of kidney dialysis services in the world. Gambro treats about 40,000 patients in 460 clinics worldwide. Renal care products comprise dialyzers, dialysis machines, blood lines and dialysis fluid. BCT includes products for the separation and handling of blood components. The Group, with revenue of approximately SEK 18 billion (USD 2.3 billion) has approximately 18,000 employees in some 40 countries. ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/02/11/19990211BIT00470/bit0001.doc http://www.bit.se/bitonline/1999/02/11/19990211BIT00470/bit0002.pdf