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

info@ibi-sa.com

IBIS/A

Via Cantonale,CH-6805 Mezzovico,Switzerland