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 AB
Emil Billbäck, CEO
+46 (0) 46 286 53 70
Håkan Johansson, CFO
+46 (0) 46 286 53 70
[email protected]
Cord Communications
Charlotte Stjerngren
+46 (0) 708 76 87 87
[email protected]
www.cordcom.se
About BONESUPPORT™
BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs. BONESUPPORT’s bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.