BONESUPPORT, based in Sweden, has obtained the US Food and Drug Administration (FDA) approval to initiate an Investigational Device Exemption (IDE) FORTIFY trial of CERAMENT G.
CERAMENT G is an injectable antibiotic-eluting bone graft substitute, which has been designed to provide local sustained delivery of gentamicin.
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Bonesupport CEO Richard Davies said: "The FDA approval of our planned IDE study with CERAMENT G is a key corporate milestone for BONESUPPORT.
“We are looking forward to beginning the FORTIFY study before the end of 2016.
“The results of this study will form a key component of our planned PMA to gain US approval for this novel antibiotic-eluting bone graft substitute."
The randomised, multicentre and controlled FORTIFY trial intends to determine the safety and efficacy of CERAMENT G as part of surgical repair of open diaphyseal tibial fractures.
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By GlobalDataIt is slated to commence at the end of this year and should enroll up to 230 patients.
The trial is primarily focused on ascertaining the efficacy of the device in healing infection at the fracture site and eliminating the requirement of surgical or non-surgical procedures to heal a fracture.
CERAMENT G’s drug-eluting properties deliver an initial ultra-high concentration of gentamicin to the bone fracture site to facilitate bone healing and promote bone remodeling.
It then delivers a longer sustainable dose above the minimum inhibitory concentration (MIC) of many of the bacteria which could cause a deep bone infection at the fracture site.
