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

Bone substitute

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- Class III Medical Device- Patented technology- Registered Trade Mark

BOVINE BONEMATRIX

BIODEGRADABLEPOLYMERS

CELLNUTRIENTS

OSTEOCONDUCTIVE

smartbone

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

MICROSTRUCTURE COMPARISON*ESEM

TARGET: Human Cortical Bone

CHEMICAL/PHYSICAL/BIOLOGICAL COMPATIBILITY

* Pertici G. et al., Tissue Engineering Part A, 2010

smartbone

HYBRID MICROSTRUCTURE COMPARISONESEM

(SAME MAGNIFICATION)

HEALTHY HUMAN BONE CADAVERIC BONE RTI STERLING

BOVINE BONEGEISTLICH BioOss

BOVINE BONEMORPHOLOGY 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

SmartBone VOLUMERIC AND STRUCTURAL DATAVIA MICROCT SCAN*

EQUIVALENT VOLUME = 515 mm3

FREE VOLUME = 140 mm3 (27%)SURFACE = 23 cm2

* Pertici G. et al., Tissue Engineering Part A, 2010

SmartBone CHEMICAL CHARACTERIZATION*(E/SEM + EDS)

* Pertici G. et al., Annals of oral and maxillofacial surgery, 2014

IS A PERFECT COMPOSITE BIOMATERIALsmartbone

POLYMERIC COATING DEGRADATION*

Polymeric film thinning during time as degradationproceeds 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 BONEMATRIX

BIODEGRADABLEPOLYMERS

CELLNUTRIENTS

smartbone

- 4 times better than the best-on-the-market (sterling)- 10 times better than the top-market-selling (biooss)

SmartBone MECHANICAL PERFORMANCESConstant speed, mono-axial, compression test performed on sterilized

samples

Rigid-elastic behaviour

* Pertici G. et al., European Cells and Materials, 2013

* Shu XZ et al., J Biomed Mater Res A, 2004; Kammerer 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 BONEMATRIX

BIODEGRADABLEPOLYMERS

CELLNUTRIENTS

smartbone

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 intoSmartBone

- 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

- 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 REQUIREMENTSOPTIMAL RESULTS DURING IN VIVO INVESTIGATIONS AND CLINICAL TRIALS

EXTREME SAFETY

7 x 7 x 7 mm10 x 10 x 10 mm10 x 10 x 20 mm10 x 20 x 20 mm14 x 12 x 6 mm14 x 12 x 7 mm14 x 12 x 8 mm14 x 12 x 9 mm14 x 12 x 10 mm14 x 12 x 12 mm14 x 12 x 16 mm14 x 12 x 20 mm14 x 12 x 24 mm15 x 30 x 20 mm15 x 30 x 30 mm15 x 30 x 40 mm15 x 30 x 50 mm15 x 30 x 60 mm16 x 14 x 6 mm16 x 14 x 7 mm16 x 14 x 8 mm16 x 14 x 9 mm

35 x 22 x 5 mm35 x 22 x 8 mm35 x 25 x 10 mm35 x 25 x 12 mm40 x 25 x 12 mm40 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 mm15 x 7 x 3.5 mm

BLOCK3 x 25 x 15 mm3 x 10 x 10 mm4 x 10 x 10 mm

WEDGE

PLATE

CYLINDER

35 x 4 x 3 mmROD

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

SmartBone on DemandTHE 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 Materials, 2013

CUSTOM MADE BONE GRAFTS NOW ALSO FOR POST-ONCOLOGIC RECONSTRUTIVE SURGERY*

* Anesi A. et al., in press EACMFS, 2014

DO’SPrepare 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 cornersAlways use collagene membranes

DONT’SDo not overfill (avoid extra material,

itdoes not shrink)Do not mix with other materialsAvoid use OF 2-4 mm chips in oralapplications

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

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

IBI SA Via Cantonale, 67CH-6805 Mezzovico-ViraSwitzerland

www.ibi-sa.cominfo@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.