Menu
Svensk version

BONESUPPORT announces - De Novo application for CERAMENT G has been submitted to the FDA

Lund, Sweden, 17.30 CET, 17 April 2020 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries today announced that the company has submitted 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.  

 

For more information contact:

BONESUPPORT AB
Emil Billbäck, CEO
+46 (0) 46 286 53 70

Håkan Johansson, CFO
+46 (0) 46 286 53 70
ir@bonesupport.com

Cord Communications
Charlotte Stjerngren
+46 (0) 708 76 87 87

charlotte.stjerngren@cordcom.se
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 that its products deliver and a Premarket approval filing with the FDA (USA) for CERAMENT G is planned in 2021. The company is based in Lund, Sweden, and the net sales amounted to SEK 155 million in 2019. Please visit www.bonesupport.com for more information.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
 



Downloads

Press release PDF (164.11 KB)