BONESUPPORT - SUPPLEMENTARY US DENOVO APPLICATION SUBMITTED


Lund, Sweden, 08:00 CET, 28-09-21 - BONESUPPORT(TM), 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 above submission is in response to this request. 

 

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
ir@bonesupport.com

Cord Communications
Charlotte Stjerngren
+46 (0) 708 76 87 87
charlotte.stjerngren@cordcom.se
www.cordcom.se

About BONESUPPORT(TM)

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 181 million in 2020. Please visit www.bonesupport.com for more information.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.


 

https://news.cision.com/bonesupport-holding-ab/r/bonesupport---supplementary-us-denovo-application-submitted,c3422609

https://mb.cision.com/Main/16090/3422609/1473955.pdf


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