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.
Brain+ launches Ayla CST Assistant following UK regulatory approval
Accelerate Diagnostics receives FDA clearance for automated blood culture system
Photocure's partner Asieris presents Cevira Phase III subgroup analysis at 2024 CSCO Annual Meeting
Boston Scientific's FARAPULSE Pulsed Field Ablation system receives Japanese regulatory approval
Implantica advances RefluxStop with CE mark study results and prepares for FDA submission
Arrowhead Pharmaceuticals seeks approval for ARO-INHBE obesity study
Nicox and Glaukos sign exclusive research and licensing option agreement
Creo Medical forms strategic partnership with Micro-Tech via EUR36.7m subsidiary sale
Epitomee Medical's Capsule cleared by FDA for weight management
Eurofins strengthens biopharma testing in US with Infinity Labs acquisition