FDA approves registration of AbSorber’s transplantation test
LinkMed’s portfolio company AbSorber has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell its XM-ONE® transplantation test in the U.S. Initially, XM-ONE® sales in the U.S. will target the kidney transplantation market valued at approximately SEK 200 million. XM-ONE® 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® transplantation test meet the tough requirements of the U.S. market. Now we can market and sell XM-ONE® 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 LinkMed’s CEO Ingemar Lagerlöf.
XM-ONE® 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.
”This is why it is of the utmost importance that every available kidney for transplantation is utilized properly, 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 USA. This makes the U.S. the single largest market in the world,” said AbSorber‘s CEO Anders 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® 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® in the U.S. market is already considerable and the first orders are expected shortly,” said Karlsson.
For LinkMed, with an ownership stake of 40 percent in AbSorber, the FDA approval entails a breakthrough for the portfolio company that has come furthest in its development. LinkMed, together with innovators, develops life science companies and has been involved in AbSorber’s development for the past eight years. In 2007, AbSorber had sales of approximately SEK 4 million. This figure is now expected to increase quickly.LinkMed’s position in the transplantation segment is further strengthened by AbSorber’s successes. In the long-term LinkMed will strive to build a larger company in the transplantation segment with a broad product portfolio.
Earlier this summer LinkMed acquired 100 percent of Olerup SSP AB, a world leading company in the transplantation market and one of Sweden’s most profitable biotech companies. Olerup develops HLA typing tests that are primarily used prior to bone-marrow transplantations. XM-ONE® and Olerup’s products complement each other and target the same customers.
“In the long term, we will strive to build a larger company in the transplantation segment with a broad product portfolio,” said Lagerlöf.
For more information:
Anders Karlsson, CEO AbSorber, tel: + 46 70 918 00 10
Ingemar Lagerlöf, CEO LinkMed, tel: +46 8 508 939 93
Also visit www.absorber.se and www.linkmed.se