Antimicrobial Biodegradable Bone Graft for Craniofacial/Maxillofacial Application

N2 Biomedical, Llc, Bedford MA

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Abstract

DESCRIPTION (provided by applicant): The incidence of traumatic facial injuries relative to injuries at the other anatomic locations has risen sharply during combat operations in Iraq and Afghanistan compared to previous military conflicts. Evan in the civilian population, traumatic craniofacial bone injury is often accompanied by injury or loss of surrounding soft tissues. There are reports of local complications and wound infection rates as high as 100% in civilians suffering gunshot wounds to the face. In the cases of open fractures that involve bone defects, the surgeon must find a way to quickly repair the wound while reducing the risk of chronic infection or osteomyelitis. In the Phase I program, we propose to develop a superior local antibiotic delivery system (in the form of beads) that also possesses resorbable and osteoinductive properties. The beads would be made of biodegradable magnesium. The beads will be coated with hydroxyapatite (HA) incorporated with gentamycin. The HA coating will be applied using Spire's commercial TPA process which produces a thin (5-10¿m) layer at a low temperature, thereby retaining the original chemical composition and phase of the HA source material. HA is well-known to initiate and expedite bone growth. We propose a system in which the HA will initiate bone growth; as the HA starts to dissolute slowly, the Mg will also degrade allowing the antibiotic to be distributed locally, preventing infection. Most importantly, there wil be no need for a subsequent operation to remove any implant or bead from the site.