SmartBone® ORTHO
Unique technology, different indications
A Bone graft born from Advanced Tissue Engineering Technology
OrganoGEN Limited is the exclusive distributor of IBI SA, an innovative hi-tech Swiss biomedical company focused on research, development and production of medical devices for tissue engineering and regenerative medicine: substitutes, grafts, 3D matrixes and 2D scaffolds.
SmartBone® ORTHO is osteoconductive, biocompatible, biodegradable and its microstructure has a porosity that promotes a fast and effective bone regeneration, thus successfully allowing its use in orthopaedic and spine surgery.
Features
SmartBone® ORTHO and SmartBone® On Demand™ are produced by combining natural mineral bone structures with bioresorbable polymers and collagen fragments. This new concept of biomaterial assembly allows the patient’s cells to grow quickly and efficiently into the bone substitute while the biopolymers degrade, providing perfect integration and osteogenesis. Moreover, thanks to this technology our graft mimics the human bone, it is mechanically strong and resistant to shaping, screws and surgical fixation maneuvers.
BOVINE BONE MATRIX
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has a chemical structure and a morphology that resemble the human bone
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is rigid, but not elastic, and thus too fragile (since the mineral matrix loses its biomechanical properties without proteins lost during the cleaning processes)
BIODEGRADABLE POLYMERS
Allow to have:
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high loading resistance
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high volumetric stability (>95%); the polymers protect the bone from early resorption
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high tenacity to screws fixation
COLLAGEN FRAGMENTS
Help to:
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promote blood cells adhesion and colonization
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guarantee a high hydrophilicity thus enhancing the biochemical cascade of signals that promotes the osteoinductive process
Human-Like Microstructure
The microstructure of SmartBone® ORTHO and SmartBone® On Demand™ composite matrix strongly resembles the human bone in terms of open, interconnected and mid-sized porosity. Indeed, it mimics the characteristics of a healthy human bone: high biocompatibility, adequate open porosity, high mechanical performance, hydrophilicity.
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SmartBone® ORTHO ands SmartBone® On Demand™ were designed to reduce the inner variability that many other bone substitutes have, due to their natural origin. IBI offers homogeneous bone substitutes with regular microstructure, porosity, density and mechanical properties.
Extremely high hydrophilicity and fast osteointegration
Thanks to its microcomposition, SmartBone® ORTHO and SmartBone® On Demand™ quickly reach an av. 38%w/w blood swelling ratio, thereby sparking the chemical signaling cascade that finally induces a robust osteointegration.
High tissue integration
SmartBone® ORTHO and SmartBone® On Demand™ microstructure and composition favor cell colonization.
In Vitro studies
The electronic microscopy analyses of in vitro cell colonization tests evidenced the presence of wide and well-structured cell formations inside SmartBone® ORTHO and SmartBone® On Demand™, proving confirmation to the biochemical data collected during ISO standard in vitro tests. Biological and histological investigations showed how our bone substitutes are very supportive substrates for cell adhesion and growth; Human adipose-tissue derived Mesenchymal Stem Cells showed in vitro capability to properly colonize the scaffold and, once induced, to differentiate.
In Vivo studies
Studies were performed to assess osteointegration on a 4-month observation timeframe. Histological analysis proved confirmation of SmartBone® ORTHO and SmartBone® On Demand™ integration, with natural bone formation, including cells and vessels colonizing pores within it over time.
Clinical studies
Clinical investigations confirmed SmartBone® ORTHO and SmartBone® On Demand™ mechanism of action: they very easily soak up large amounts of blood, thus starting micro coagulation to occur inside the graft itself and hence strongly enhancing graft integration (as far as the local micro coagulation sparkles a chemical cascade that is essential for patient native cells ingrowth into the graft); the first weeks are then needed for cellular colonization of the graft, which is also enhanced by the presence of gelatine (offering RGD-end as site-specific terminals for adhesion via linking with integrins from cells) that offers a viable environment for cells to spread onto; meanwhile, this time lag is also necessary for the degradation of the thin polymeric film, which progressively fades away leaving mineral structure for cells to consolidate and promoting the formation of new living bone (also by means of formation of new vessel); following months are needed for the integration of the graft with the native patient bone, due also to vascularization and new bone formation inside the graft via complete remodeling.
Strong, easy to shape and resistant to screws!
A Block (10x10x10 mm) can be harshly shaped, then drilled with two holes at a very small distance. As a result, there is no powder formation and the block doesn’t break into pieces!
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During a bone reconstructive surgery, a block can be easily shaped and directly drilled in place. The absence of powder formation helps allowing to perform the drilling in situ! and the screws stay firmly in place. Moreover, hydrophilicity is very high and this allows blood to coagulated into the graft and hence spark the remodeling process.