The company 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.
The application is specified for the indication osteomyelitis (bone infection) and can potentially result in an approval at the latter end of 2020.
“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.
During the winter, BONESUPPORT has been in dialogue with the US Food and Drug Administration, the 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. The 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.
“Breakthrough device” categorization can be assigned to products that are considered to provide more effective treatment of severe conditions. The purpose is to provide an expedited review of the application for market approval.
BONESUPPORT has previously announced that the company plans to submit a premarket approval application (PMA) for CERAMENT G to the FDA in 2021. The 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.