THE NEXT FRONTIER OF BONE REGENERATION

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1 THE NEXT FRONTIER OF BONE REGENERATION where Technology meets Nature swiss made

2 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. BIODEGRADABLE POLYMERS 27% OPEN POROSITY BOVINE BONE MATRIX CELL NUTRIENTS mimics the human bone and much more: 1 2 EXTREMELY BIOCOMPATIBLE its open-porous microstructure mimics the human bone and PROMOTES CELL COLONIZATION 3 4 It is highly hydrophilic and READILY ABSORBS BLOOD thus enhancing the chemical cascade of signals that promotes the osteogenic process It has IMPRESSIVE MECHANICAL PERFORMANCES, withstanding heavy surgical manoeuvres and precision shaping and offering a HIGH TENACITY TO FIXATION SCREWS

3 THE NEXT GENERATION OF OSTEOGENIC BIOMATERIALS from chips to custom-made bone grafts for oral and maxillofacial surgery Advantages Dust free shaping Resistance to extreme loads High fixation tenacity High volumetric stability Strongly osteogenic Perfect for: Sinus Lift procedures Vertical and horizontal bone augmentations Intrabony defects Peri-implant defects

4 HYSTOLOGIES AND DENSITY* 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). 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. *All the hystological and densitometric analyses have been performed on humans four months after grafting

5 IN ACTION Bone augmentation after extraction with SmartBone Block Post extraction gap in 23 requiring the maintenance of volumes and cross increase in area Full thickness flap and intramedullary channeling. SmartBone block is fixed with 2 screws (area 24, 25); SmartBone wedge is inserted (area 23). Check-up two months after surgery Four months after surgery, there is good evidence of bone regeneration and density, allowing the safe fixation of 4 implants. Collagen Membrane covering, prior to suture. Four months post surgery: excellent bone density, optimal for safe implant therapy. Sinus lift with SmartBone microchips Incision and detachment of the Schneider membrane. Filling with SmartBone MicroChips (1-2mm), for vertical bone increase. Reconstruction with SmartBone Microchips after bone loss due to fracture Residual bone and inflammatory tissue lesion after removal of 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.

6 KEY FEATURES Extremely high Biocompatibility Fully compliant with ISO requirements; optimal results during in vivo investigations and clinical trials. 100µm 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. 100µm Healthy human iliac crest bone SmartBone Monoaxial compression tests High mechanical performances 30 SmartBone has a rigid pseudoelastic behaviour. It bears 3 times the competitor s maximum load and is 4 times more rigid SmartBone MPa (stress) best performing competitor % of compression (displacement) High hydrophilicity Thanks to its microcomposition, SmartBone quickly reaches an av. 38% blood swelling, thereby allowing a robust osteointegration High tissue integration SmartBone s microstructure and composition favour cell colonization. The electronic microscopy analysis of in vitro cell colonization tests evidenced the presence of wide and well-structured cell formations inside SmartBone 3 µm

7 SmartBone Block 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 SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SMB SmartBone Plate 3 x 25 x 15 mm SMP SmartBone Wedge 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 SMW SMW SMW SMW SMW SMW SmartBone Cylinder ø11 x h20 mm ø12 x h20 mm ø14 x h20 mm ø16 x h20 mm ø11 x h10 mm ø14 x h14 mm SMC SMC SMC SMC SMC SMC SmartBone Rod 35 x 4 x 3 mm SMR SmartBone Special U Shape 15 x 6 x 4 mm 15 x 7 x 3.5 mm SMS SMS SmartBone Special C Shape ø8 x h 12 mm SMS SmartBone Special L Shape 15 x 7 x 6 mm SMS SmartBone Microchips mm (0,5 g) mm (1 g) 1-2 mm (1 g) 1-2 mm (2 g) 2-4 mm (3 g) 2-4 mm (10 g) SMC SMC SMC SMC SMC SMC SmartBone Granules

8 A NEW GENERATION OF BIOMATERIALS 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 scaffolds. IBI believes that regenerative medicine and tissue engineering represent the future in healthcare. IBI has advanced competencies and core skills in processing materials for biomedical applications, used to develop proprietary technologies to build its new and innovative products. IBI commits to safety and quality management: IBI is ISO 13485:2003 and ISO9001:2008 compliant and its production is GMP certified. IBI S/A Via Cantonale 67, CH-6805 Mezzovico, Switzerland SmartBone is a marked class III medical device IBI-SBD002UKrev3