BONESUPPORT – SUPPLEMENTARY US DENOVO APPLICATION SUBMITTED
Lund, Sweden, 08:00 CET, 28-09-21 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company has submitted a supplementary 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 in Q1 of 2022. In February of this year, the FDA requested further data and clarifications on BONESUPPORT’s DeNovo application. The