Delays within FDA postpones CERAMENT G De Novo decision
Lund, Sweden, 08:00 CET, February 28, 2022 –BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announced that due to internal delays at the U.S. Food and Drug Administration (FDA), the agency has informed BONESUPPORT that a response to the company’s De Novo application for marketing authorization for the antibiotic eluting product CERAMENT G for the indication osteomyelitis (bone infection) will be delayed with a few weeks. For more information contact: BONESUPPORT HOLDING ABEmil Billbäck, CEO+46 (0) 46 286 53 70 Håkan Johansson, CFO