Novel Antimicrobial Nanocomposite Bone Graft Material Phase II

Infected open fractures are a common battlefield injury, particularly in the current conflicts in Iraq and Afghanistan. The current standard of care for infected open fractures involves irrigation, debridement, initial stabilization, and antibiotic therapy. In order to provide local antibiotic therapy and fill dead space, antibiotics are often combined with bone cement, rolled into beads, and placed in the bone defect. While this approach has been effective in preventing infection, it does not address the growing incidence of antibiotic-resistant bacteria or the highly resistant bacterium, acinetobacter baumanii, that has emerged as the most frequently detected bacterium in warfighter wounds. In addition, since bone cement does not resorb, numerous subsequent surgical procedures are required to remove the beads and harvest and graft bone, increasing morbidity and cost. Luna is developing a novel bone graft substitute material that will simultaneously deliver antimicrobial drugs directly into the infected site and act as a resorbable scaffold for new bone growth. The base material has a biomimetic architecture that is designed to resorb at a patient-specific rate via the natural synergistic remodeling activity of osteoclasts and osteoblasts. Luna has assembled a highly qualified, multidisciplinary technical and clinical team required for a successful program.