Therapy Areas: Devices
Bonesupport gains FDA clearance for CERAMENT G in open fractures
14 March 2024 -

Swedish orthobiologics company Bonesupport Holding AB (STO:BONEX) announced on Thursday that the US Food and Drug Administration (FDA) has cleared CERAMENT G for use in open fractures.

These fractures, often resulting from trauma, pose a significant risk of infection.

CERAMENT G is an orthopaedic medical device combination matrix that consists of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, protecting against bacteria colonisation.

With this clearance, the US market potential for CERAMENT G more than doubles. It is the first and only combination product approved in the United States for this indication.

Emil Billbäck, CEO of Bonesupport, highlighted the significance of this expanded indication, providing American surgeons with a potent tool to treat skeletal injuries while mitigating infection risks through local antibiotic elution.