Accelerated road to market approval for CERAMENT® G in the US – BONESUPPORT[TM] submits De Novo application
Lund, Sweden, 8 am CET, 23 March 2020 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that 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.During the winter, BONESUPPORT has been in dialogue with the US Food and Drug Administration, the FDA, to investigate