Abstract

Industrie Biomediche Insubri SA (IBI) developed new technologies to improve the properties of natural materials for biomedical applications: indeed, IBI produces Smartbone^®, a bone substitute specifically developed for orthopaedic reconstructive surgery. This innovative scaffold has a composite structure based on a bovine derived bone matrix reinforced with biodegradable polymers and bioactive agents.

The bovine derived matrix allows maintaining an adequate 3D-structure, with an open-porosity and a biomimetic chemistry (Ca and P based), biopolymers permit to achieve good mechanical properties (in the range of healthy human cortical bone), while bioactive agents promote cell adhesion, proliferation and high hydrophilicity (essential also for blood absorption and thus sparkling chemical signals cascade for regeneration). Smartbone^® is produced according to GMP (Good Manufacturing Practice) standards, applying only human-use approved components and CE mark is under obtainment for both conventional and unconventional shapes.

Thanks to the very high performances of Smartbone^®, particularly its impressively higher mechanical properties with respect to other bone substitutes, IBI developed and launched custom-made products, “SmartBone^® on demand™”, solving single specific cases of bone reconstruction: starting from a common CT scan, IBI can provide the adequate substitute for every kind of defect.

This technology was successfully applied to a custom reconstruction of the left cheekbone portion of a young man who was hit by a grenade during former-Yugoslavian war. Patient CT scan was acquired, a 3D real model was built by stereolithography, grafts were manually shaped on the real model while planning surgery. Mathematical files of the so obtained grafts shapes were used to pilto a CAM 5-axis machine to cut the final shape of raw materials that were then reinforced with IBI’s proprietary process. Once in operatory room, present residuals, applied aside the battlefield, were removed, leaving space for the custom made graft. Surgery was fast and very precise allowing to obtain a very satisfactory result both in terms of anatomical reconstruction and also functional.