BONESUPPORT enrolled the first patient in the pivotal Investigational Device Exemption FORTIFY trial, “A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures.”
The trial will enroll up to 230 patients at up to 30 centers in the U.S. and Europe. BONESUPPORT received FDA approval to launch the trial in 3Q16; data will support a Premarket Approval filing for the injectable antibiotic-eluting bone graft substitute in the U.S.
FORTIFY will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. Primary endpoints include the absence of deep infection at the fracture site and the lack of secondary procedures to promote union.
BONESUPPORT enrolled the first patient in the pivotal Investigational Device Exemption FORTIFY trial, "A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures."
The trial will enroll up to 230 patients at up to 30 centers in the U.S. and Europe. BONESUPPORT received...
BONESUPPORT enrolled the first patient in the pivotal Investigational Device Exemption FORTIFY trial, “A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures.”
The trial will enroll up to 230 patients at up to 30 centers in the U.S. and Europe. BONESUPPORT received FDA approval to launch the trial in 3Q16; data will support a Premarket Approval filing for the injectable antibiotic-eluting bone graft substitute in the U.S.
FORTIFY will assess CERAMENT G’s ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. Primary endpoints include the absence of deep infection at the fracture site and the lack of secondary procedures to promote union.
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