"We had obviously hoped to launch CERAMENT G in the US, for the indication bone infections, during the spring 2021, but the approval process with CERAMENT G being "the first of its kind", will require additional interactions with FDA," said Emil Billbäck, CEO of BONESUPPORT.
In
"We will work to accommodate the requests by the FDA. Good guidance on requirements to reach approval has been given by the FDA and the dialogue is very productive" said Emil Billbäck.
Revised timing for potential DeNovo approval for the indication bone infections is estimated for Q1 2022.
As previously announced, BONESUPPORT intends to start the registration process regarding CERAMENT G for non-infected indications, including trauma, during the end of 2021, through a PMA pathway based on the outcome of the FORTIFY study. This process is independent from DeNovo.
BONESUPPORT will hold a conference call and an online presentation on
https://tv.streamfabriken.com/press-conference-2021
Participant dial in number
SE: +46 856642651
US: +18558570686
Participant Pin code
50998592#
For more information contact:
Emil Billbäck, CEO
+46 (0) 46 286 53 70
Håkan Johansson, CFO
+46 (0) 46 286 53 70
ir@bonesupport.com
Charlotte Stjerngren
+46 (0) 708 76 87 87
charlotte.stjerngren@cordcom.se
www.cordcom.se
EU Market Abuse Regulation
This information is such information as
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
BONESUPPORT and CERAMENT are registered trademarks of
https://news.cision.com/bonesupport-holding-ab/r/bonesupport-s-fda-notification--approval-on-denovo-pathway-for-cerament-g-will-require-additional-da,c3297276
https://mb.cision.com/Main/16090/3297276/1380152.pdf
(c) 2021 Cision. All rights reserved., source