nanoMAG evaluated the biocompatibility, fixation, and healing of BioMg® magnesium-based alloy implants for craniomaxillofacial fracture fixation plates and screws in a load-bearing mandible model. This study was funded by the National Institutes of Health.
Bone fixation was monitored throughout the 4-week healing period using palpation and monitoring of mastication and feeding habits, as well as CT scans at 30 days post-op.
Non-decalcified samples were embedded in polymer and five micrometer sections were cut and processed. Hematoxylin and eosin (H&E), Sanderson’s, Toluidine Blue, Goldner Trichrome and Mason’s Trichrome stainings were performed.
Based on the success of this pilot study, nanoMAG has initiated, and is currently executing a 76 implant GLP study that will be used to support regulatory approvals. The study covers both biocompatibility and mechanical integrity at timepoints ranging from 30 days to beyond 12 months.
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