�The Swedish biotech party AbSorber has been given clearance by the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE� transplantation test in the U.S. Initially, sales of XM-ONE� in the U.S. will target the kidney transplantation market valued at about SEK cc million. XM-ONE� previously received CE marker and is approved for sales inside the EU.
AbSorber's transplantation test provides enhanced diagnostic value compared to existent tests and facilitates twin the right organ with the correct patient, thereby increasing the probability of a successful transplantation.
"Approval from the FDA demonstrates that AbSorber and the XM-ONE� transplant test meet the tough requirements of the U.S. market. Now we privy market and sell XM-ONE� full on in the U.S., initially focusing on the kidney transplantation segment, followed by a following step into the marrow and lung transplantation segment," said Anders Karlsson, CEO AbSorber. XM-ONE� is unique in that it is the first base 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 betwixt the transplanted organ and the recipient's immune organization. Anti-endothelial cell antibodies have been shown to play a key role in post-transplantation rejection reactions.
"XM-ONE� adds critical supplementary info to a transplantation clinic's decision devising process in their quest to downplay risk and rejection reactions," said Karlsson.
Today thither is a great deficit in kidneys for transplanting. Wait times for patients are acquiring 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 utilised, that is to tell that the right kidney is matched with the right recipient role. The come 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 earth," said Karlsson.
AbSorber has established honorable contact with ten illustrious 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� together with the Karolinska University Hospital and the Sahlgrenska University Hospital. The results of the study are organism published in conjunction with the globular congress for transplantations in Sydney in the middle of August. In total, there ar approximately 200 transplantation clinics in the U.S. "Interest in XM-ONE� in the U.S. market is already considerable and the first-class honours degree orders ar expected shortly," said Karlsson.
AbSorber develops products that facilitate more successful transplantations. AbSorber's number one product, the transplantation test XM-ONE�, detects key antibodies responsible for post-transplantation rejection reactions. XM-ONE� is already CE marked and approved for gross revenue in the EU.
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