Initial small animal in vivo tests on BioMg® have been conducted at the North Carolina State A & T University, under sponsorship of the National Science Foundation. Side-by-side femoral implants of BioMg® with Lactosorb (PLGA-based bioresorbable polymers) were placed in 12 rabbits for time points ranging from 2 weeks to 52 weeks. The goal of this study was to establish that the histological reaction surrounding the BioMg® implant is equivalent to that of the predicate material, in this case PLGA.
The observation of bone encapsulating the BioMg® implants was observed via the Micro CT images taken at the early time points in the study (Figure 3 below).
The histology data for the BioMg® samples after 52 week post surgery indicate the implant has experienced approximately 50 volume % absorption over the 52 weeks.
The implant appears to be encapsulated by new bone structure with a transition layer that has formed between the BioMg® implant and the surrounding new bone structure. By Scanning Electron Microscope (SEM) images and linear scans, the alloying elements were located in a) the residual implant, b) a transition corrosion layer and c) in new bone that encapsulated and replaced the implant. The SEM images for Mg, Ca and P are seen below.
These observations support the model of a slow stable surface absorption that occurs over time transforming the core implant to a new transition layer platform upon which new bone structure can connect to and replace over time. The transition layer becomes enriched in Calcium and Phosphorus during the bioabsorption process which is indicative of new bone formation.
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