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.

1. SmartBone is the next
generation of osteogenic
biomaterial for bone
replacement in oral and
maxillofacial surgery
Bone substitute

2. SmartBone is an innovative 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 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

6. MICROSTRUCTURE COMPARISON*
ESEM
TARGET: Human Cortical Bone
CHEMICAL/PHYSICAL/BIOLOGICAL COMPATIBILITY
* Pertici G. et al., Tissue Engineering Part A, 2010
smartbone

7. 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

8. 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

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*
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

11. - 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

12. * 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

13. 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

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 (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

16. 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

17. SmartBone on Demand
THE NEW FRONTIER OF CUSTOM MADE BONE GRAFTS:
THE FUTURE IS HERE, TODAY!

18. CUSTOM MADE BONE GRAFTS FOR ORAL AND MAXILLOFACIAL
RECONSTRUTIVE SURGERY*
* Grecchi F. et al., European Cells and Materials, 2013

19. CUSTOM MADE BONE GRAFTS NOW ALSO
FOR POST-ONCOLOGIC RECONSTRUTIVE SURGERY*
* Anesi A. et al., in press EACMFS, 2014

20. 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

21. 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

22. 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

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.