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SmartBone: the innovative bone substitute for oral surgery and maxillofacial surgery
- 1. SmartBone is thenext generation of osteogenic biomaterial for bone replacement in oral and maxillofacial surgery Bone substitute
- 2. SmartBone is aninnovative graft for bone replacement in oral and maxillofacial reconstructive surgery
- 3. Hybrid bioactive material,partially synthetic and partially natural - CE mark for all applications in bone regeneration - Class III Medical Device - Patented technology - Registered Trade Mark BOVINE BONE MATRIX BIODEGRADABLE POLYMERS CELL NUTRIENTS OSTEOCONDUCTIVE smartbone
- 5. ADVANTAGES • Dust freeshaping • Resistance to extreme loads • High fixation tenacity • High volumetric stability • Strongly osteogenic • Sinus Lift procedures • Vertical and horizontal bone augmentations • Intrabony defects • Peri-implant defects PERFECT FOR
- 6. MICROSTRUCTURE COMPARISON* ESEM TARGET: HumanCortical Bone CHEMICAL/PHYSICAL/BIOLOGICAL COMPATIBILITY * Pertici G. et al., Tissue Engineering Part A, 2010 smartbone
- 7. HYBRID MICROSTRUCTURE COMPARISON ESEM (SAMEMAGNIFICATION) HEALTHY HUMAN BONE CADAVERIC BONE RTI STERLING BOVINE BONE GEISTLICH BioOss BOVINE BONE MORPHOLOGY Wide pores Too wide pores Too regular pores FEATURES Too high variability Too high variability Low variability MECHANICAL RESISTANCE Good strengths Fragile Extremely fragile TOP SELLING US MARKET TOP SELLING COMPETITORPERFORMING COMPETITORTARGET * Rossi F. et al., Journal of Tissue Engineering and Regenerative Medicine, 2014
- 8. SmartBone VOLUMERIC ANDSTRUCTURAL DATA VIA MICROCT SCAN* EQUIVALENT VOLUME = 515 mm3 FREE VOLUME = 140 mm3 (27%) SURFACE = 23 cm2 * Pertici G. et al., Tissue Engineering Part A, 2010
- 9. SmartBone CHEMICAL CHARACTERIZATION* (E/SEM+ EDS) * Pertici G. et al., Annals of oral and maxillofacial surgery, 2014 IS A PERFECT COMPOSITE BIOMATERIAL smartbone
- 10. POLYMERIC COATING DEGRADATION* Polymericfilm thinning during time as degradation proceeds almost independently from starting thicknesses (2, 3, 5, 10 micron) Complete polymer degradation after around 4 months: • Matches the natural bone ingrowth • Tissue regeneration * Pertici G. et al., Annals of oral and maxillofacial surgery, 2014 BOVINE BONE MATRIX BIODEGRADABLE POLYMERS CELL NUTRIENTS smartbone
- 11. - 4 timesbetter than the best-on-the-market (sterling) - 10 times better than the top-market-selling (biooss) SmartBone MECHANICAL PERFORMANCES Constant speed, mono-axial, compression test performed on sterilized samples Rigid-elastic behaviour * Pertici G. et al., European Cells and Materials, 2013
- 12. * Shu XZet al., J Biomed Mater Res A, 2004; Kämmerer PW et al., European Cells and Materials, 2011; Hennessy KM et al., Biomaterials, 2008; Hwang DS et al., Biomaterials, 2007; Bouhadir KH et al., Biotechnol Prog, 2001; Rosellini E et al., J Biomed Mater Res A, 2009. Cell nutrients are immobilized biomolecules containing the RGD (Arg-Gly-Asp) sequence, which promotes cell adhesion* and hence sparkles the formation of new bone* BIOLOGY BOVINE BONE MATRIX BIODEGRADABLE POLYMERS CELL NUTRIENTS smartbone
- 13. IN VITRO TEST Porosityis optimal for cell adhesion and proliferation (all others have too big pores to host cells) Cells growth for 25 days into SmartBone ESEM FLUORESCENCE HISTOLOGY GFP+ SAOS-2 osteoblast-like cells cultured into SmartBone GFP+ SAOS-2 cells cultured into SmartBone
- 14. - Extremely biocompatible -Very cell attractive - Readily absorbs blood - High mechanical stability IT SPARKLES THE FORMATION OF NEW BONE! human histology, 4 months after grafting BIOLOGY
- 15. - Cytotoxicity (cellculture method) - Sensitization (Guinea Pig Maximisation) - Intracutaneous reactivity (Albino Rabbits) - Systemic toxicity test (on mice) - Implantation (Albino Rabbits at 4 and 8 weeks) - Genotoxicity (bacterial reverse mutation assay and mammalian cell gene mutation assay in mouse lymphoma L5178Y cells) FULLY COMPLIANT WITH ISO 10993:2010 REQUIREMENTS OPTIMAL RESULTS DURING IN VIVO INVESTIGATIONS AND CLINICAL TRIALS EXTREME SAFETY
- 16. 7 x 7x 7 mm 10 x 10 x 10 mm 10 x 10 x 20 mm 10 x 20 x 20 mm 14 x 12 x 6 mm 14 x 12 x 7 mm 14 x 12 x 8 mm 14 x 12 x 9 mm 14 x 12 x 10 mm 14 x 12 x 12 mm 14 x 12 x 16 mm 14 x 12 x 20 mm 14 x 12 x 24 mm 15 x 30 x 20 mm 15 x 30 x 30 mm 15 x 30 x 40 mm 15 x 30 x 50 mm 15 x 30 x 60 mm 16 x 14 x 6 mm 16 x 14 x 7 mm 16 x 14 x 8 mm 16 x 14 x 9 mm 35 x 22 x 5 mm 35 x 22 x 8 mm 35 x 25 x 10 mm 35 x 25 x 12 mm 40 x 25 x 12 mm 40 x 25 x 14 mm ∅ 11 x h 20 mm ∅ 12 x h 20 mm ∅ 14 x h 20 mm ∅ 11 x h 10 mm ∅ 14 x h 14 mm 15 x 6 x 4 mm 15 x 7 x 3.5 mm BLOCK 3 x 25 x 15 mm 3 x 10 x 10 mm 4 x 10 x 10 mm WEDGE PLATE CYLINDER 35 x 4 x 3 mm ROD U SHAPE ∅ 8 x h 12 mm 15 x 7 x 6 mm C SHAPE L SHAPE 0.25 - 1 mm (0.5 cc, 1 cc, 2 cc, 5 cc) 1-2 mm (2 cc, 4 cc) 2-4 mm (5 cc) MICROCHIPS & GRANULES
- 17. SmartBone on Demand THENEW FRONTIER OF CUSTOM MADE BONE GRAFTS: THE FUTURE IS HERE, TODAY!
- 18. CUSTOM MADE BONEGRAFTS FOR ORAL AND MAXILLOFACIAL RECONSTRUTIVE SURGERY* * Grecchi F. et al., European Cells and Materials, 2013
- 19. CUSTOM MADE BONEGRAFTS NOW ALSO FOR POST-ONCOLOGIC RECONSTRUTIVE SURGERY* * Anesi A. et al., in press EACMFS, 2014
- 20. DO’S Prepare the receivingsite well • properly expand soft tissues • properly microdrill native bone Ensure a tight contact to host Bone • appropriate graft shaping • firmly tight screws Smooth edges and corners Always use collagene membranes DONT’S Do not overfill (avoid extra material, it does not shrink) Do not mix with other materials Avoid use OF 2-4 mm chips in oral applications
- 21. IBI SA isan innovative hi-tech Swiss biomedical company focused on research, development and production of medical devices for tissue engineering and regenerative medicine. A NEW GENERATION OF BIOMATERIALS www.ibi-sa.com
- 22. IBI has strongcompetencies and core skills in processing materials for biomedical applications, used to develop proprietary technologies to produce new and innovative medical devices. IBI believes that regenerative medicine and tissue engineering represent the future for health and key topic in life sciences. IBI pays extreme attention to safety and quality: IBI is ISO13485-2012 and ISO9001-2008 certified; IBI production is GMP certified. is reserch is vision is quality
- 23. IBI SA Via Cantonale,67 CH-6805 Mezzovico-Vira Switzerland www.ibi-sa.com info@ibi-sa.com Information, data, clinical details, images and all that is embodied in this presentation are not disclosed to any third parties without the prior written consent of Industrie Biomediche Insubri SA. All rights reserved, 2015.
Editor's Notes
- #21 Che poi diventi un flyer!!!