Brief: Bonesupport Holding Says Study Results On Fortify Are Inconclusive

BoneSupport Holding AB

09/09/2021 18:49

Sept 9 (Reuters) - Bonesupport Holding AB  BONEX.ST :
    * BONESUPPORT HOLDING SAYS STUDY RESULTS ON FORTIFY ARE
INCONCLUSIVE
    * PRIMARY SAFETY ENDPOINT FOR CERAMENT G WAS MET
    * VERY HIGH DROP-OUT RATE HAS LED TO FORTIFY NOT QUALIFYING
TO
REQUIREMENTS OF A PMA APPLICATION
    * NONE OF SECONDARY PARAMETERS WERE CONCLUSIVE
    * BONESUPPORT HOLDING- PRIMARY COMPOSITE END POINT SUCCESS
WAS 64%
IN TREATMENT GROUP AND 66% IN CONTROL GROUP
    * BONESUPPORT WILL WORK WITH FDA TO REVIEW POSSIBLE
REGULATORY
PATHWAYS FOR CERAMENT G FOR INDICATION TRAUMA

Source text for Eikon:  ID: 
Further company coverage:  BONEX.ST 

 ((Reuters.Briefs@thomsonreuters.com;))