FDA approves IDE study for bone graft substitute, Cerament G

Bonesupport, the Scandinavian medical technology company, has received FDA approval to begin an IDE (Investigational Device Exemption) study for their injectable antibiotic-eluting bone graft substitute, Cerament G, which provides a local sustained delivery of the antibiotic, gentamicin.

The drug received CE mark approval in February 2013 and is now marketed in 19 countries outside the US.

Repair of open diaphyseal tibial fractures

Bonesupport’s Fortify study 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 centres 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

Reducing the risk of deep bone infection

Cerament G combines Cerament’s bone healing and bone remodelling properties with the antibiotic, gentamicin. When used, it provides 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, reducing the risk of deep bone infection at the fracture site. This antibiotic-eluting profile is intended to help protect the bone healing process.

‘…key corporate milestone for Bonesupport…’

CEO of Bonesupport, 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 antibiotic-eluting bone graft substitute.”

The trial is expected to begin by the end of 2016.