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SmartBone is the next
generation of osteogenic
biomaterial for bone
replacement in oral and
maxillofacial surgery
Bone sub...
SmartBone is an innovative graft for
bone replacement in oral and
maxillofacial reconstructive surgery
Hybrid bioactive material, partially synthetic and partially natural
- CE mark for all applications in bone regeneration
-...
ADVANTAGES
• Dust free shaping
• Resistance to extreme loads
• High fixation tenacity
• High volumetric stability
• Strong...
MICROSTRUCTURE COMPARISON*
ESEM
TARGET: Human Cortical Bone
CHEMICAL/PHYSICAL/BIOLOGICAL COMPATIBILITY
* Pertici G. et al....
HYBRID MICROSTRUCTURE COMPARISON
ESEM
(SAME MAGNIFICATION)
HEALTHY HUMAN BONE CADAVERIC BONE
RTI STERLING
BOVINE BONE
GEIS...
SmartBone VOLUMERIC AND STRUCTURAL DATA
VIA MICROCT SCAN*
EQUIVALENT VOLUME = 515 mm3
FREE VOLUME = 140 mm3 (27%)
SURFACE ...
SmartBone CHEMICAL CHARACTERIZATION*
(E/SEM + EDS)
* Pertici G. et al., Annals of oral and maxillofacial surgery, 2014
IS ...
POLYMERIC COATING DEGRADATION*
Polymeric film thinning during time as degradation
proceeds almost independently from start...
- 4 times better than the best-on-the-market (sterling)
- 10 times better than the top-market-selling (biooss)
SmartBone M...
* Shu XZ et al., J Biomed Mater Res A, 2004; Kämmerer PW et al., European Cells and Materials, 2011; Hennessy KM et al., ...
IN VITRO TEST
Porosity is optimal for cell adhesion and
proliferation (all others have too big pores to host
cells)
Cells ...
- Extremely biocompatible
- Very cell attractive
- Readily absorbs blood
- High mechanical stability
IT SPARKLES THE FORMA...
- Cytotoxicity (cell culture method)
- Sensitization (Guinea Pig Maximisation)
- Intracutaneous reactivity (Albino Rabbits...
7 x 7 x 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
1...
SmartBone on Demand
THE NEW FRONTIER OF CUSTOM MADE BONE GRAFTS:
THE FUTURE IS HERE, TODAY!
CUSTOM MADE BONE GRAFTS FOR ORAL AND MAXILLOFACIAL
RECONSTRUTIVE SURGERY*
* Grecchi F. et al., European Cells and Material...
CUSTOM MADE BONE GRAFTS NOW ALSO
FOR POST-ONCOLOGIC RECONSTRUTIVE SURGERY*
* Anesi A. et al., in press EACMFS, 2014
DO’S
Prepare the receiving site well
• properly expand soft tissues
• properly microdrill native bone
Ensure a tight conta...
IBI SA is an innovative hi-tech Swiss biomedical company
focused on research, development and production of medical
device...
IBI has strong competencies and core skills in processing materials for
biomedical applications, used to develop proprieta...
IBI SA
Via Cantonale, 67
CH-6805 Mezzovico-Vira
Switzerland
www.ibi-sa.com
info@ibi-sa.com
Information, data, clinical det...
SmartBone: the innovative bone substitute for oral surgery and maxillofacial surgery
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SmartBone: the innovative bone substitute for oral surgery and maxillofacial surgery

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SmartBone is a new hybrid bioactive bone substitute specifically developed for bone regeneration in reconstructive surgery.
SmartBone is produced by combining a bovine mineral bone matrix with bioactive resorbable polymers and cell nutrients. This new concept of composite biomaterial promotes a quick growth of the patient’s cells into SmartBone while its biopolymers degrade, providing perfect integration and osteogenesis.

Published in: Health & Medicine
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SmartBone: the innovative bone substitute for oral surgery and maxillofacial surgery

  1. 1. SmartBone is the next generation of osteogenic biomaterial for bone replacement in oral and maxillofacial surgery Bone substitute
  2. 2. SmartBone is an innovative graft for bone replacement in oral and maxillofacial reconstructive surgery
  3. 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
  4. 4. ADVANTAGES • Dust free shaping • 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
  5. 5. MICROSTRUCTURE COMPARISON* ESEM TARGET: Human Cortical Bone CHEMICAL/PHYSICAL/BIOLOGICAL COMPATIBILITY * Pertici G. et al., Tissue Engineering Part A, 2010 smartbone
  6. 6. HYBRID MICROSTRUCTURE COMPARISON ESEM (SAME MAGNIFICATION) 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
  7. 7. SmartBone VOLUMERIC AND STRUCTURAL 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
  8. 8. SmartBone CHEMICAL CHARACTERIZATION* (E/SEM + EDS) * Pertici G. et al., Annals of oral and maxillofacial surgery, 2014 IS A PERFECT COMPOSITE BIOMATERIAL smartbone
  9. 9. POLYMERIC COATING DEGRADATION* Polymeric film 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
  10. 10. - 4 times better 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
  11. 11. * Shu XZ et 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
  12. 12. IN VITRO TEST Porosity is 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
  13. 13. - 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
  14. 14. - Cytotoxicity (cell culture 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
  15. 15. 7 x 7 x 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
  16. 16. SmartBone on Demand THE NEW FRONTIER OF CUSTOM MADE BONE GRAFTS: THE FUTURE IS HERE, TODAY!
  17. 17. CUSTOM MADE BONE GRAFTS FOR ORAL AND MAXILLOFACIAL RECONSTRUTIVE SURGERY* * Grecchi F. et al., European Cells and Materials, 2013
  18. 18. CUSTOM MADE BONE GRAFTS NOW ALSO FOR POST-ONCOLOGIC RECONSTRUTIVE SURGERY* * Anesi A. et al., in press EACMFS, 2014
  19. 19. DO’S Prepare the receiving site 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
  20. 20. IBI SA is an 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
  21. 21. IBI has strong competencies 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
  22. 22. 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.

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