experts in bone regeneration Spine Surgery Product Line When Innovation Meets Performance

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1 experts in bone regeneration Spine Surgery Product Line When Innovation Meets Performance

2 At the core of all our products: Our proprietary MBCP Technology Over 650 published studies, 30 years of clinical experience Clinically validated in over 650 peer-reviewed studies and with over 1,000,000 patients treated, MBCP has been the scaffold of choice in bone reconstruction for over 20 years. Made of a combination of hydroxyapatite and tricalcium phosphate, Biomatlante s biphasic bone scaffolds are constantly evolving to meet new challenges stemming from tissue engineering where surgeons need to combine scaffolds with either biological fluids or active agents in order to treat particularly challenging patients. Biomatlante is an active participant in numerous research programs seeking to improve outcomes for particularly challenging patients. 100 µm 2 µm microporosity The performance of MBCP is characterized by: Clinical efficacy equivalent to that of autologous bone graft; Less complications than autologous grafts; No donor site pain and infections; Biocompatible. 1 1 Ransford, A.O. et al., (1998). Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br, 80(1): macroporosity High Specific Surface Area (SSA) for maximum permeability Biomatlante s unique 3-step manufacturing process creates a micro-macroporous structure of biphasic calcium phsophate ceramics, making them osteomimetic, enabling MBCP to exhibit highly osteogenic properties for filling large bone defects. MBCP Human Bone 1 month 6 months 1 year Sector: Spine Indication: Posterolateral fusion Study Type: Clinical study Number of Patients: 58 Product: MBCP Sticks Analysis: These results confirm the benefits of using calcium phosphate ceramics as bone graft substitutes for posterior spinal fusion in teenagers and young adults. J Delécrin., (2000), «A synthetic porous ceramic as a bone graft substitute in the surgical treatment of scoliosis» Spine (25) 2

3 Spine Surgery Line For over 20 years, our single purpose has been to bring to market state of the art solutions for regenerative surgery. Backed by extensive clinical evidence, our innovative Spine Surgery Line is simply unique. Join us into the new era, When Innovation Meets Performance. Interbody fusion Posterolateral fusion In Oss Cervical Cages MBCP Sticks MBCP Inserts Cervical & Lumbar cages MBCP Syringe MBCP Gel Trabecular cages 3

4 INTERBODY FUSION Building on Biomatlante s core MBCP Technology, In Oss is an innovative and moldable bone graft, composed of Biphasic Calcium Phosphate and a hydrogel. In Oss keeps the original graft shape and bone volume. The hydrogel acts as a carrier for rapid vascularization and mineralization whereas MBCP is gradually resorbed to be replaced by vital architectured bone. In Oss Line of Moldable Synthetic Bone Graft Developed to facilitate handling during bone grafting procedures, In Oss can fit into any grafting site. With its small diameter syringe and easy to use delivery system. Syringe 0.5mL & 1mL 4 months bone remodelling with haversian system - Goat model MBCP Gel Injectable Synthetic Bone Graft MBCP Gel is an injectable bone graft hydrogel used to regenerate and fill bone gaps, with or without interbody devices. (ex: a cyst or in conjunction with a trabecular cage). It offers an optimal balance between fluidity (helps to fill bone defects or devices) and viscosity (minimal washout). MBCP Gel can flow through a 16 gauge needle. Syringe - 1ml Product Benefits Ready to use Resorbable Volume stability Excellent handling characteristics Moldable 100% synthetic Injectable Fast Bone Ingrowth 4

5 INTERBODY FUSION MBCP Inserts Interbody cervical and lumbar fusion Pioneer in Biphasic Calcium Phosphate Solutions, especially in custom inserts for spinal cages, Biomatlante has been the Partner of choice for major spinal companies worldwide for over 20 years. MBCP Custom Inserts have been designed specifically for interbody cages, they intrinsically fit perfectly, with multiple design options to compensate for additional screws and plates. + = Biomatlante has worked with it most of the leading cage manufacturers to design, develop and machine custom inserts to perfectly fit their cages. Depending on the manufacturer s strategy, they can be available already pre-fitted inside the cage or come in a separate sterile package. Biomatlante s unique 3-step manufacturing process creates a micro-macroporous structure of biphasic calcium phsophate ceramics, making them osteomimetic, enabling MBCP to exhibit highly osteogenic properties for filling large bone defects. Product Benefits Resorbable Quicker procedure Easy handling Make your cages stand out, unique cage and bespoke insert 5

6 POSTEROLATERAL FUSION MBCP Syringe MBCP Syringe is commonly used in challenging cases where the bioactivity of the biomaterial should be further boosted by either biological fluids or active agents. The biomaterial comes pre-packaged in a convenient syringe designed specifically with convenience in mind: 1. Connect the syringe containing the aspirate or agent to the luer lock of MBCP Syringe and inject the fluid Spinal Fusion with MBCP 5 year follow up 2. Remove the cap of MBCP Syringe and easily extrude the material by pushing the plunger. Passuti, N., (1989) «Macroporous calcium phosphate ceramic performance in human spine fusion» Clin Orthop (248), Syringe 5cc & 10cc MBCP Sticks MBCP Sticks have been shown to be effective in lumbar posterior fusion. MBCP sticks are mostly used in association with autograft for posterolateral graft. 1/3 of MBCP Sticks Sticks Large variety available 2/3 of autologous bone Spine 2000 (25), J Delécrin «A synthetic porous ceramic as a bone graft substitute in the surgical treatment of scoliosis» High Quality Bone Graft Global interconnected porosity of 70%: 2/3 of macropores (>10µm) 1/3 of micropores (<10µm), due to a unique know-how 100% Synthetic: 60% HA (Hydroxyapatite) 40% β-tcp (Tricalcium Phosphate Beta) 6

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8 About Biomatlante Based near Nantes, France, Biomatlante specializes in synthetic biomaterials for bone regeneration and has been a world leader in bone graft technologies for over 20 years, selling its products in over 50 countries. Biomatlante s products are routinely used in orthopedics and trauma surgery, in spine and dental surgery. Biomatlante strives to integrate a strategy of strong innovation and product development required to meet and exceed the needs of today s market. Biomatlante s R&D team has close ties with universities and research centers across the world, guaranteeing it remains at the cutting edge of innovation and providing the intellectual protection necessary to foster long-term projects. Bibliography MBCP Technology Ransford, A.O. et al., (1998). Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br, 80(1): Gouin, F., Delecrin, J., Passuti, N., Touchais, S., Poirier, P., Bainvel, J. (1995) Biphasic macroporous calcium phosphate ceramic bone substitute for filling bone defects: A report of 23 cases. Revue de Chirurgie Orthopedique: 81; Daculsi, G., Corlieu, P., D Arc, M., Gersdorff, M. (1992) Macroporous biphasic calcium phosphate efficiency in mastoid cavity obliteration: experimental and clinical findings. Annals of Otology, Rhinology & Laryngology: 101 (8); Daculsi, G., Passuti, N., Martin, S., Deudon, C., Legeros, R., Raher, S. (1990). Macroporous calcium phosphate ceramic for long bone surgery in humans and dogs. Clinical and histological study. Journal of Biomedical Materials Research: 24; Daculsi, G., Jegoux, F., and Layrolle, P. (2009). «The micro macroporous biphasic calcium phosphate concept for bone reconstruction and tissue engineering», Advanced Biomaterials: Fundamentals, Processing, and Application, B. Basu. et al., J. Wiley and sons Inc., pp Delécrin, J. (2000) «A synthetic porous ceramic as a bone graft substitute in the surgical treatment of scoliosis» Spine (25) In Oss Fabre, T., Chauveaux, D., Moinard, M., Mais, C., Durand, M., Pollart, C.,Daculsi, G. (2008) Pilot Study of Safety and Performance of a Mixture of Calcium Phosphate Granules Combined with Cellulosic-derived Gel after Tunnel Filling Created during Surgical Treatment of Femoral Head Aseptic Osteonecrosis, Key Engineering Materials Vols pp Pascal-Moussellard, H., Aguado, E., Catonné, Y., Rouvillain, J.L., Daculsi, G. (2003) «Evaluation of an intervertebral cervical cage filled with injectable bone substitute, Cervical Spine Research Society» (poster) Daculsi, G., Mousselard, H., Goyenvalle, E., Pilet, P., Delplace, S., Aguado, E. (2005) Minimal invasive surgery in spine, new development of injectable ceramic MBCP for vertebral body bone filling: in vivo experiment, Key Engineering Materials Vols , pp Weiss, P., Clergeau, L.P., Enckel, B., Amouriq, Y., Giumelli, B., Jean, A., Daculsi, G., (2005) MBCP Gel Weiss, P., Layrolle, P., Clergeau, LP., Enckel, B., Pilet, P., Amouriq, Y., Daculsi, G., Giumelli, B., (2007). The Safety and efficacity of an injectable bone substitute in dental sockets demonstrated in a human clinical trial. Biomaterials. Aug;28(22):: Weiss, P., Clergeau, LP., Enckel, B., Amouriq, Y, Giumelli, B., Jean, A., and Daculsi, G., (2005) A New injectable Bone Substitue Concept (MBCP Gel ): First Clinical Results in Notes A New Injectable Bone Substitute Concept (MBCP Gel ): First Clinical Results in Human Maxillo-Facial Surgery, Key Engineering Materials Vols pp Daculsi, G., LeGeros, R., Kokubo, T. (2008) Tricalcium phosphate/ hydroxyapatite biphasic calcium phosphate (BCP) bioceramics, in Bioceramics and theirs clinical applications, editor, Woodhead publishing, pp Davy, A., Gauthier, O., and al. (2004) Assessment of Cancellous Bone Architecture after Implantation of an Injectable Bone Substitute, Catherine., Key Engineering Materials Vols pp Daculsi, G., Lazennec, J.Y., Catonné, Y., Saillant, G., Pascal-Mousselard, H. (2008) Les cages intervertébrales cervicales, analyse critique de la littérature, Maîtrise Orthopédique 2005, 147 : 8-17Vols pp Human Maxillo-Facial Surgery, Key Engineering Marerials Vols pp Catherine, A., Davy, O. Gauthier, and al. (2004) Assessment of Cancellous Bone Architecture after Implantation of an Injectable Bone Substitute,, Key Engineering Materials Vols pp Read instructions for use for a complete list of warnings, precautions, possible adverse events and other important medical information. Not all products are registered or available in every country/region. Please check with Biomatlante representative for availability and further information. In Oss, EZ Cure & MBCP are trademarks of Biomatlante, SA. This document is not applicable for the US. Manufacturer: BIOMATLANTE 5 rue Édouard Belin Z.A. Les Quatre Nations Vigneux-de-Bretagne France contact@biomatlante.com +33 (0) Biomatlante, All rights reserved C MS4 Rev. 4 Last Update: June 2017