BONESUPPORT TM, an emerging leader in orthobiologics for the management of bone injuries, announced that the company has received market authorization from the US Food and Drug Administration (FDA), for the company's antibiotic eluting product CERAMENT G, for the indication bone infection (osteomyelitis).
CERAMENT G has received market authorization through a De Novo process, which is one of the regulatory pathways available when there is no previous comparable product ("predicate device") legally marketed. CERAMENT G has been given "Breakthrough device" categorization by FDA, as it adds significant clinical value compared to existing treatment options by enabling natural bone healing protected by locally eluted antibiotics, in a one-stage-procedure. CERAMENT G has been proven to significantly improve the treatment outcomes for patients suffering from bone infection, with a reduced risk of reinfection and amputation. CERAMENT G is the first and only bone graft, with antibiotic elution, approved for the US market. BONESUPPORT estimates that there are 50 k patients treated each year in the US market for bone infections. The market is growing with 5-7% a year.