Swedish orthobiologics company Bonesupport Holding AB (STO:BONEX) said on Tuesday that it has submitted a market authorisation application to the US Food and Drug Administration (FDA) for CERAMENT V (vancomycin), its antibiotic-eluting bone graft substitute.

The product is designed to treat bone infections, particularly those caused by methicillin-resistant bacteria such as MRSA and MRSE.

CERAMENT V has been approved for several years in Europe, where it accounts for 15% of Bonesupport's antibiotic-releasing product sales. The FDA previously granted CERAMENT V "breakthrough device" designation for bone infection treatment.

Bonesupport's CERAMENT G, approved by the FDA in 2022, has demonstrated superior efficacy in managing bone infections, supported by nearly 17,000 clinical data points. If approved, CERAMENT V would provide physicians with another targeted option for infection management.

Local antibiotic-releasing bone grafts are increasingly critical in reducing reliance on systemic antibiotics and addressing antibiotic resistance.