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Study results on FORTIFY are inconclusive Lund , Sweden , 19:40 CET , 09 09 21 – BONESUPPORT ™ , an emerging leader in orthobiologics for the management of bone injuries , today announced inconclusive results for the company's Investigational Device Exemption ( IDE ) study ; FORTIFY . The primary safety endpoint for CERAMENT G was met . The FORTIFY study was initiated in 2017 with the purpose to evaluate the ability of CERAMENT G to improve the treatment outcomes for patients with open tibia fractures G - A II - IIIB . Last patients follow up took place in June 2021 . The drop - out rate , defined as difference between enrolled and completed patients , was 29 % and lost to follow up was 18 % and 9 % for the treatment group and control group respectively . Subjects drop out is generally high with all trauma studies . In the FORTIFY study , with a majority of the patient final follow - ups taking place during the COVID pandemic , the drop - out rate has been very high with only 143 qualified subjects of 201 enrolled for the composite efficacy endpoint at 12 months . The very high drop - out rate has led to FORTIFY not qualifying to the requirements of a PMA application . The primary composite end point success was 64 % in the treatment group ( CERAMENT G ) and 66 % in the control group ; non - significant difference . None of the secondary parameters were conclusive . The severe trauma that patients with open tibia fractures G - A II - IIIB have been exposed to is known by high variability in bone healing , infection incidence and soft tissue recovery . Nevertheless , the failure to reach conclusion on the study data is both surprising and disappointing . BONESUPPORT will work with FDA to review possible regulatory pathways for CERAMENT G for the indication trauma . Conference call and online presentation BONESUPPORT will host a conference call and an online presentation Friday , SEPT 10 , at 10:00 CET . The call will be hosted by Emil Billbäck , CEO , Håkan Johansson , CFO , and Michael Diefenbeck , CMO . The presentation will be held in English . The dial - in numbers for the conference call are : SE : +46 856642651 PIN : 19381497 # UK : +44 3333000804 PIN : 19381497 # US : +1 6319131422 PIN : 19381497 # The presentation will be webcasted and can be followed here : https://tv.streamfabriken.com/press-conference-sept-2021 PRES UU15 - UT en