Bonesupport Holding AB (Bonesupport) (STO:BONEX), an orthobiologics company for the management of bone injuries, announced on Monday that it will submit a De Novo application to the US Food and Drug Administration (FDA) to obtain a market approval for the company's antibiotic-releasing product, CERAMENT G.

This application is specified for the indication osteomyelitis (bone infection) and can potentially result in an approval at the latter end of 2020.

During the winter of 2019, Bonesupport said it has been in dialogue with the US FDA to investigate whether CERAMENT G could, through a De Novo application, obtain market approval for the indication osteomyelitis. A De Novo application can be made when there is no comparable established alternative (predicate device) on the market.

This dialogue with the FDA has resulted in CERAMENT G being granted designation as a 'Breakthrough Device' and that Bonesupport has decided to submit a De Novo application in April 2020. A positive message on the De Novo application would shorten the route for CERAMENT G to the US market by about 18 months, Bonesupport added.

Following Bonesupport's application submission for market approval, is a period where the FDA is reviewing the extensive documentation. If everything goes according to plan, Bonesupport expects a market approval to be obtained at the latter end of 2020. However, the length of the actual review is difficult to predict since the process is dependent on FDA's feedback and potential requests for further information or documentation.

CERAMENT G enables local antibiotic release, which significantly reduces the risk of reinfection and amputation in bone infection, as well as reduces the risk of developing antibiotic resistance.

Bonesupport had previously announced that the company plans to submit a premarket approval application (PMA) for CERAMENT G to the FDA in 2021.

This De Novo application applies to the indication osteomyelitis (bone infection) and Bonesupport still intends to submit a PMA application for further indications, including trauma, by the end of 2021.

Bonesupport develops and commercialises injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs.