Synthetic and absorbable autograft substitute with osteoinduction

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1 putty Synthetic and absorbable autograft substitute with osteoinduction Quality made in Germany

2 Synthetic and absorbable autograft substitute with osteoinduction Information on the synthetic bone grafting material NanoBone NanoBone putty The new generation of bone grafting Extremely quick bone formation Nano structure enhances angiogenesis and thus quick bone formation Controlled osteoinduction active agglomeration of growth factors (e.g. endogenous BMP) Complete remodelling cell-mediated resorption as a result of mere osteoclastic capabilities Synthetic and safe no risk of disease transmission at constant quality Ready to use 250 The large internal surface area is decisive for protein adhesion and the biological functionality Internal surface area m 2 /g sintered HA of bovine origin 5.2 synthetic silicate-substituted sintered HA The internal surface area (m 2 /g) has been measured using mercury porosimetry and BET. The size of the internal surface area controls the resorption speed of NanoBone NanoBone putty

3 NanoBone putty The main component of autologous bones is hydroxylapatite. In order to support the natural process of bone formation, nature should serve as role model. The revolutionary HA crystallites Size as in natural bones on the nanometer scale Not connected with each other and thus not sintered Physiological proteins attach to the HA crystallites Silica gel matrix Large internal surface area, adhesion of autologous molecules - high degree of bioactivity Release of SiO 2 Quick vascularisation Accelerated wound healing Matrix change = biologisation of synthetic material (condition for the remodelling process) aspect of NanoBone is its nanostructure: Nanocrystalline hydroxylapatite (HA) is embedded in a highly porous silica gel matrix*. * Gerber et al.: Nanostructuring of biomaterials - a pathway to bone grafting substitute. European Journal of Trauma 32 (2006): New technology - NanoBone technology 3 nm 100 nm 100 nm 3 Transmission electron microscope image (TEM): HA crystallites with the same size as in natural bones 4 Transmission electron microscope image in scanning mode (STEM): HA crystallites embedded in a silica gel matrix

4 Synthetic and absorbable autograft substitute with osteoinduction Information on the synthetic bone grafting material NanoBone NanoBone putty Natural processes - completely new structures Bone grafting due to remodelling processes 1 Quick vascularisation*: Immunohistological illustration of the vessels (vwf) 2 Beginning restructuring with osteoclasts (TRAP)* 3 Enrichment of endogenous BMP-2*: Immunohistological illustration Silica gel matrix (organic matrix) 100 % 80 % 60 % 40 % Autologous molecules are deposited in the nanopores 1 AUTOLOGOUS SILICA ORGANIGS Biologisation complete 2 3 Remodelling Activation of autologous physiological reconstruction 20 % 0 % 5 days 10 days Time after implantation 15 days Organics input - SiO 2 output** Organics SiO 2 The illustration shows the matrix change: Within 10 days, the SiO 2 matrix is substituted by a matrix made of organic autologous molecules. This is biologisation. * Götz et al: Immunohistochemical characterization of nanocrystalline hydroxyapatite silica gel (NanoBone ) osteogenesis: A study on biopsies from human jaws. Clin Oral Res 2008;19: ** Xu et al.: Early Matrix Change of a Nanostructured Bone Grafting Substitute in the Rat, J Biomed Mater Res B 2009;

5 NanoBone putty Controlled ostoinductivity In addition to osteoconduction, NanoBone has osteoinductive properties. These osteoinductive activities are limited to the implantation area where natural bone incorporating all skeletal bone properties is generated. It is subject to the biological processes of remodelling, and will be resorbed if not functionally strained. 100 % 80 % 33.7% Composition of ectopic bones Soft tissue 60 % 40 % 45.0% Medullary cavity Bone 20 % 16.4% NanoBone 0 % 6 weeks 12 weeks 4.9% 26 weeks Time after implantation 4 Intramuscular osteoinduction in sheep models: It is locally strictly limited to the implantation area; within 26 weeks, a functional bone block is generated (see micro CT). Osteoclasts and osteoblasts are responsible for the cellular remodelling and resorption process. Beginning formation of medullary cavity Cellular resorption of NanoBone granulate Significant osteoneogenesis Active osteoblasts Granulate enriched with BMP-2 Osteoid 5 Intramuscular tissue formation similar to the healing process of bone defects. Histological image, decalcified cut, HE staining, 12 weeks after intramuscular implantation 6 Micro CT of the piece of bone intramuscularly formed after 26 weeks with typical cortical bone and autograft 7 Proof of the BMP-2 enrichment (brown) in granulates. Immunohistology, decalcified cut, 12 weeks intramuscular in sheep * Helms et al.: Comparisons of the osteoinductive properties of nanocrystalline bone substitute material on hydroxylapatite basis (NanoBone S) with a porous hydroxylapatite ceramics (Cerabone) in an ectopic implantation in a sheep, EF , DKOU 2010

6 Synthetic and absorbable autograft substitute with osteoinduction Information on the synthetic bone grafting material NanoBone NanoBone putty Indication samples Depressed fracture of the tibia head Radius fractures Pseudoarthrosis Back filling of cysts Spinal stabilisation Back filling of defects after tumour surgery Acetabulum reconstruction Corrective osteotomy Pathologic fractures Bone necrosis or for all indications which allow the use of autologous autograft.

7 NanoBone putty Requirements for state-of-the-art bone substitute materials Autologous autograft NanoBone Good biocompatibility x x No side effects x x Good new bone quality x x x Quicker formation of bone x x x Most complete restoration of the functionality within the new formed bone x x Mechanical and chemical stability (yes/no according to the indication), material volume x x Maintenance and/or formation of elements of bone structure x x Adapted biodegradation (passively solution-mediated / actively cell-mediated) x x Optimised amount and quality of newly formed bone material x x Excerpt from the list of literature Harms C, Helms K, Taschner T, Stratos I, Ignatius A, Gerber T, Lenz S, Rammelt S, Vollmar B, Mittlmeier T: Osteogenic capacity of a nanocrystalline bone substitute in a weightbearing defect at the ovine tibial metaphysis, Biomaterials submitted Gerber T, Lenz S, Holzhüter G, Götz W, Helms K, Harms C, Mittlmeier T: Nanostructuring of Bone Grafting Substitutes- A pathway to osteoinductivity, Key Engineering Materials 2012; Ganz C, Xu W, Holzhüter G, Götz W, Vollmar B, Gerber T: Comparison of bone substitutes in a tibia defect model in Wistar-rats, Key Engineering Materials 2012; Kirchhoff M, Lenz S, Henkel KO, Frerich B, Holzhüter G, Radefeldt S, Gerber T: Lateral augmentation of the mandible in minipigs with a synthetic nanostructured hydroxyapatite block, J Biomed Mater Res B Appl Biomater Feb;96(2): Kruse A, Jung RE, Nicholls F, Zwahlen RA, Hämmerle CHF, Weber FE: Bone regeneration in the presence of a synthetic hydroxyapatite/silica oxide-based and a xenogenic hydroxyapatite-based bone substitute material., Clin. Oral Impl. Res. 22, 2011; Helms K, Harms C, Lenz S, Mittlmeier T, Gerber T: Comparison of the osteoinductive properties of nanocrystalline bone substitute material on hydroxylapatite basis(nanobone S) with a porous hydroxylapatite ceramics (Cerabone) in an ectopic implantation in a sheep, German congress for orthopaedics and trauma surgery 2010 Götz W, Lenz S, Reichert C, Henkel KO, Bienengräber V, Pernicka L, Gundlach KKH, Gredes T, Gerber T, Gedrange T, Heinemann F: A preliminary study in osteoinduction by a nano-crystalline hydroxyapatite in the mini pig, Folia Histochem Cytobiol. 2010:48(4): 589 ( ) Xu W, Holzhüter G, Sorg H, Wolter D, Lenz S, Gerber T, Vollmar B: Early matrix change of a nanostructured bone grafting substitute in the rat., J Biomed Mater Res B Appl Biomater Nov; 91(2):692-9 Abshagen K, Schrodi I, Gerber T, Vollmar B: In vivo analysis of biocompatibility and vascularization of the synthetic bone grafting substitute NanoBone, J Biomed Mater Res A 2009 Nov; 91(2): Hebecker, R, Sola S, Lenz S, Mann S, Piek J: A new nanostructured bone substitute for the use in neurosurgery - results of a prospective study in lumbar fusion and further results, 59th Annual Meeting of the German Society of Neurosurgery 2008, poster

8 For questions with regard to application, product and/or the ordering of NanoBone putty please do not hesitate to contact us! MANUFACTURER ARTOSS GmbH Friedrich-Barnewitz-Straße Rostock Germany Phone: +49 (0) Fax: +49 (0) info@nanobone.de Web: ITEM LIST for NanoBone putty Order number Description NanoBone putty 0.5 ml NanoBone putty 1.0 ml NanoBone putty 2.5 ml NanoBone putty 5 ml NanoBone putty 10 ml DISTRIBUTED BY: nanobone.de