BONESUPPORT to Submit a De Novo Application for CERAMENT G

By Julie A. Vetalice

BONESUPPORT to Submit a De Novo Application for CERAMENT G

In April, BONESUPPORT will submit a De Novo application to FDA for approval of antibiotic-releasing CERAMENT® G in an indication to treat osteomyelitis. The approval could come by the end of 2020. (Update: the application was submitted in mid-April.)

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

BONESUPPORT has previously announced that the company plans to submit a Premarket Approval (PMA) application for CERAMENT G to FDA in 2021. The De Novo application applies to the indication osteomyelitis, and BONESUPPORT intends to submit a PMA application for further indications, including trauma, by the end of 2021.

“The benefits of CERAMENT G for patients and clinics are validated in a number of very strong clinical studies that have paved the way for our strong sales in Europe, where CERAMENT G accounts for a clear majority of our sales. It shows the potential of our antibiotic-releasing products as we now work for accelerated market approval in the United States. A positive message on the De Novo application would shorten the route for CERAMENT G to the US market by about 18 months,” said Emil Billbäck, CEO of BONESUPPORT.

Product Labels: Synthetic Bone Graft

Tags: Regulatory