AbSorber: FDA Approves Registration of AbSorber's Transplantation Test.

STOCKHOLM, Sweden -- The Swedish biotech company AbSorber has been given clearance by the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE[R] transplantation test in the U.S. Initially, sales of XM-ONE[R] in the U.S. will target the kidney transplantation market valued at approximately SEK 200 million. XM-ONE[R] previously received CE marking and is approved for sales within the EU.

AbSorber's transplantation test provides enhanced diagnostic value compared to existing tests and facilitates matching the right organ with the right patient, thereby increasing the probability of a successful transplantation.

"Approval from the FDA demonstrates that AbSorber and the XM-ONE[R] transplantation test meet the tough requirements of the U.S. market. Now we can market and sell XM-ONE[R] full on in the U.S., initially focusing on the kidney transplantation segment, followed by a next step into the heart and lung transplantation segment," said Anders Karlsson, CEO AbSorber. XM-ONE[R] is unique in that it is the first standardized test that can detect antibodies against the cells that line the inside of blood vessels. These endothelial cells are the first point of contact between the transplanted organ and the recipient's immune system. Anti-endothelial cell antibodies have been shown to play a key role in post-transplantation rejection reactions.

"XM-ONE[R] adds critical supplementary information to a transplantation clinic's decision making process in their quest to minimize risk and rejection reactions," said Karlsson.

Today there is a great deficit in kidneys for transplantation. Wait times for patients are getting longer and it happens that patients die waiting for a new kidney.

"This is why it is of the outmost importance that every kidney available for transplantation is properly utilized, that is to say that the right kidney is matched with the right recipient. The total number of kidney transplantations per year globally is 56,000 of which 17,000 take place in the U.S. This makes the U.S. the single largest market in the world," said Karlsson.

AbSorber has established good contact with ten renowned transplantation centers in the U.S. Of these, four centers - Johns Hopkins University Hospital, Baylor University Medical Center, The Ohio State University Medical Center and Mass. General Hospital - have participated in a multicenter clinical trial of XM-ONE[R] together with the Karolinska University Hospital and the Sahlgrenska University Hospital. The results of the study are being published in conjunction with the global congress for transplantations in Sydney in the middle of August. In total, there are approximately 200 transplantation clinics in the U.S. "Interest in XM-ONE[R] in the U.S. market is already considerable and the first orders are expected shortly," said Karlsson.

AbSorber develops products that facilitate more successful transplantations. AbSorber's first product, the transplantation test XM-ONE[R], detects key antibodies responsible for post-transplantation rejection reactions. XM-ONE[R] is already CE marked and approved for sales in the EU.

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