Bonesupport Submits Cerament V to FDA for Bone Infection

Bonesupport, a company that specializes in orthobiologics to manage bone injuries, has submitted a U.S. Food and Drug Administration (FDA) market authorization application for its Cerament V (vancomycin) antibiotic-eluting bone graft substitute for the indication of bone infection.

Cerament G’s market approval in 2022 was based on extensive efficacy and patient safety data, according to the company, with almost 17,000 clinical data points. The data showed that Cerament G is superior to prior standard options to manage bone infections.

Bone grafts with local antibiotic release have become a crucial tool in the ambition to drastically reduce the need for systemic antibiotic use and fight antibiotic resistance, according to Bonesupport.

With Cerament V’s market authorization, physicians would have another tool to manage bone infections primarily caused by Methicillin-Resistant Staphylococcus (MRSA or MRSE). Cerament V has had market approval in Europe for several years and represents 15% of the sales of antiobiotic-releasing products.

Cerament V previously earned breakthrough device status from the FDA for the indication of bone infection.

The company’s injectable bio-ceramic bone graft substitutes remodel the patient’s own bone and have the ability to elute drugs. Bonesupport is conducting several clinical studies to further demonstrate its products’ clinical and health economic benefits.

The company is based in Lund, Sweden and had 2024 net sales of SEK 899 million ($81.6 billion as of December 31, 2024).