BONESUPPORT Receives Market Authorization for CERAMENT G in the US
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.