Swedish orthobiologics company Bonesupport Holding AB (STO:BONEX) announced on Tuesday that it will move its US market application for CERAMENT V (vancomycin) for bone infection from the 510(k) route to the De Novo process.

The company determined during US Food and Drug Administration (FDA) review that CERAMENT V, if authorised, could form a new product category that the 510(k) pathway cannot accommodate.

According to Bonesupport, this shift aligns with the precedent set when CERAMENT G created a new regulatory category upon its approval in May 2022.

Extensive clinical, process, and pharmacological documentation will be transferred to the De Novo framework in December 2025.

The De Novo review period is 150 days, compared with 90 days under 510(k).

CEO Torbjörn Sköld said the change may strengthen the long-term position of CERAMENT V by enabling it to stand as the sole product in a new category.

Bonesupport expects the transition to occur before year-end and described its dialogue with the FDA as constructive.

CERAMENT V has already received FDA breakthrough device designation for the treatment of bone infection.