Bonesupport AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, has received approval from the US Food and Drug Administration (FDA) to begin an IDE (Investigational Device Exemption) study with Cerament G. Cerament G is an injectable antibiotic-eluting bone graft substitute that provides local sustained delivery of gentamicin. Cerament G received CE mark approval in February 2013 and is now marketed in 19 countries outside the US.
The FORTIFY study, a randomized multicenter controlled trial, will evaluate the safety and efficacy of Cerament G as part of surgical repair of open diaphyseal tibial fractures. The trial will enrol up to 230 patients at up to 30 centers globally, with the aim of having at least 50% of the study data coming from US subjects.
In addition to evaluating the safety of Cerament G use, primary endpoints of the study include: Absence of deep infection at the fracture site; Absence of secondary procedures (surgical or nonsurgical) intended to promote fracture union; BONESUPPORT anticipates starting the FORTIFY trial by the end of 2016.
Cerament G combines the bone healing and bone remodeling properties of Cerament with the antibiotic, gentamicin. Cerament G drug-eluting properties enable it to provide an initial ultra-high concentration of gentamicin to the environment of the bone fracture and then 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. This unique antibiotic-eluting profile helps protect the bone healing process and to promote bone remodeling.
Richard Davies, CEO of Bonesupport, 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.”
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