swiss made
THE NEXT FRONTIEROF BONE REGENERATION
where Technologymeets Nature
SmartBone is new composite bone substitute specifically developed for bone regeneration in oral and maxillofacial reconstructive surgery.
WHAT’S NEW?SmartBone is produced by combining natural mineral bone structures with bioactive resorbable polymers. This new concept of biomaterial assembly allows the patient’s cells to grow quickly and efficiently into Smartbone while its biopolymers degrade, providing perfect integration and osteogenesis.
BIODEGRADABLEPOLYMERS
CELL NUTRIENTS
27%OPENPOROSITY
BOVINEBONEMATRIX
mimics the human bone and much more:
EXTREMELY BIOCOMPATIBLE1
3 It is highly hydrophilic and READILY ABSORBS BLOOD thus enhancing the chemical cascade of signals that promotes the osteogenic process
2 its open-porous microstructure mimics the humanbone and PROMOTES CELL COLONIZATION
4 It has IMPRESSIVE MECHANICAL PERFORMANCES,withstanding heavy surgical manoeuvres and precision shapingand o�ering a HIGH TENACITY TO FIXATION SCREWS
Advantages• Dust free shaping
• Resistance to extreme loads
• High fixation tenacity
• High volumetric stability
• Strongly osteogenic
THE NEXT GENERATIONOF OSTEOGENIC BIOMATERIALS…
…from chips to custom-made bone grafts
for oral and maxillofacial surgery
Perfect for:• Sinus Lift procedures
• Vertical and horizontal
bone augmentations
• Intrabony defects
• Peri-implant defects
High tissue integration
SmartBone’s microstructure and composition favour cell colonization. The electronic microscopy analysis ofin vitro cell colonization tests evidenced the presence of wide and well-structured cell formations inside SmartBone
KEY FEATURES
High mechanical performances
SmartBone has a rigid pseudoelastic behaviour.It bears 3 times the competitor’s maximum load and is 4 times more rigid
% of compression (displacement)
MP
a (s
tre
ss)
0 -2 -5 -7 -9 -11 -13 -16 -18 -21 -23 -25 -27 -30 -32 -34 -37 -39 -41 -43 -46 -48-50
30
25
20
15
10
5
Monoaxial compression tests
SmartBone
best performing competitor
High hydrophilicityThanks to its microcomposition, SmartBone quickly reaches an av. 38% blood swelling, thereby allowing a robust osteointegration
Extremely high Biocompatibility
Fully compliant with ISO 10993 requirements; optimal results duringin vivo investigations and clinical trials.
Open porosity and microstructure
The microstructure of SmartBone’s composite matrix strongly resembles the human bone in terms of an open mid-sized 27% porosity.
Healthy human iliac crest bone SmartBone
100µm 100µm
3 µm
Sinus lift with SmartBone microchips
Incision and detachment of the Schneider membrane.
Filling with SmartBone MicroChips (1-2mm), for vertical bone increase.
Collagen Membrane covering, priorto suture.
Four months post surgery: excellent bone density, optimal for safe implant therapy.
Reconstruction with SmartBone Microchips after bone loss due to fracture
Residual bone and inflammatory tissue lesion after removalof the tooth stump.
Bone reconstruction with SmartBone Microchips.
After 5 months: new bone formation with optimal density and structure. No membrane residuals.
Insertion of the implant fixture.
Bone augmentation after extraction with SmartBone Block
Post extractiongap in 23 requiringthe maintenance of volumes and cross increase in area 24-25.
Full thickness flapand intramedullary channeling. SmartBone block is fixed with 2 screws (area 24, 25); SmartBone wedgeis inserted (area 23).
Check-up two months after surgery
Four months after surgery, there is good evidence of bone regeneration and density, allowingthe safe fixation of 4 implants.
IN ACTION
HYSTOLOGIES AND DENSITY*
CT scanning confirms high tissue
integration of SmartBone, evidencing
no demarcation line between graft and
native bone and showing normal
morphometric structure: the density of
newly formed bone (tested in the
SmartBone graft area surrounding the
fixation mini-screw) averages 500HU.
A robust ingrowth of new bone into
grafted SmartBone (black arrow)
is evidenced by the presence of
osteocytes inside the lacunae (yellow
arrow); mature lamellar bone formations
are evident and osteoblasts forming new
bone tissue in the surrounding areas
where young woven bone is present
(green arrows).
The lines of bone growth (purple lines)
are easily identified.
The SmartBone graft (black arrows)
is progressively substituted by new
young bone (green arrows): osteoblasts
are visible both in the active and in the
quiescent status, when, after having
formed mature bone (yellow arrows),
they become osteocytes.
The spatial progression of the
osteointegration process of the
SmartBone graft (black arrows) reflects its
temporal evolution: spreading osteoblast
colonies (grey arrows) support progressive
substitution by newly-formed young bone
(green arrows), followed by the
transformation into mature lamellar bone
(yellow arrows).
*All the hystological and densitometric analyses have been performed on humans four months after grafting
SMW014010
SMW014020
SMW014030
SMW014040
SMW014050
SMW014060
SMC012010
SMC012020
SMC012030
SMC012040
SMC012050
SMC012060
SMR015010
SMS016010
SMS016020
SMS016110
SMS016210
SMP013010
SMB011005
SMB011010
SMB011020
SMB011030
SMB011110
SMB011120
SMB011130
SMB011140
SMB011150
SMB011160
SMB011170
SMB011180
SMB011190
SMB011210
SMB011220
SMB011230
SMB011240
SMB011250
SMB011310
SMB011320
SMB011330
SMB011340
SMB011410
SMC010100
SMC010110
SMC010200
SMC010201
SMC010300
SMC010301
SmartBone Wedge
SmartBone Cylinder
SmartBone Rod
SmartBone Special U Shape
SmartBone Special C Shape
SmartBone Special L Shape
SmartBone Plate
SmartBone Block
SmartBone Microchips
SmartBone Granules
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
ø11 x h20 mm
ø12 x h20 mm
ø14 x h20 mm
ø16 x h20 mm
ø11 x h10 mm
ø14 x h14 mm
35 x 4 x 3 mm
15 x 6 x 6 mm
15 x 7 x 3.5 mm
ø8 x h 12 mm
15 x 7 x 6 mm
3 x 25 x 15 mm
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
20 x 20 x 30 mm
0.25 - 1 mm (0,5 g)
0.25 - 1 mm (1 g)
1 - 2 mm (1 g)
1 - 2 mm (2 g)
2-4 mm (3 g)
2-4 mm (10 g)
IBI is 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 sca�olds.IBI believes that regenerative medicine and tissue engineering represent the future in healthcare.
IBI has advanced competenciesand core skills in processing materials for biomedical applications, usedto develop proprietary technologiesto build its new and innovative products.IBI commits to safety and quality management: IBI is ISO 13485:2003and ISO9001:2008 compliant and its production is GMP certified.
A NEW GENERATION OF BIOMATERIALS
www.smartbone.ch
SmartBone is a marked class III medical device
www.ibi-sa.com
IBIS/A
Via Cantonale,CH-6805 Mezzovico,Switzerland