During the review process of the company’s 510(k) application, it has become clear that CERAMENT V (vancomycin), if granted market authorization, may come to establish an entirely new product category. The De Novo process allows for this opportunity, but 510(k) does not. This follows the same principle as when CERAMENT G (gentamicin), upon its market authorization in May 2022, established a new regulatory category. The decision to change the regulatory process is being made in close and constructive dialogue with the FDA.

A large amount of reviewed clinical documentation, process descriptions, and pharmacological data will therefore be transferred to the De Novo process, which is expected to occur in December 2025. Instead of the 90-day review period for a 510(k), the De Novo process has a 150-day review period.

“We see great potential in the opportunity to set the standard for yet another product category. The 510(k) pathway to market authorization is somewhat shorter, but with a potential De Novo approval, we stand significantly stronger in the long term when CERAMENT V becomes the sole product in a new category. Our ambition is that the transfer to the De Novo process will take place before year-end, and we are optimistic about the continued handling and review. Our dialogue with the FDA is very good” says Torbjörn Sköld, CEO of BONESUPPORT.

CERAMENT V has previously been granted “breakthrough device” designation for the indication of bone infection by the FDA.