experts in bone regeneration Osteotwin Sports Surgery Line When Innovation Meets Performance

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1 experts in bone regeneration Osteotwin Sports Surgery Line When Innovation Meets Performance

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3 Sports Surgery Line For more than 20 years, our philosophy has been to develop performing and safe solutions for regenerative surgeries. Backed by this extended clinical background, we invite you to discover our innovative and unique Sports Surgery Line. Join us into the new era, When Innovation Meets Performance. Bioactivity M Mineral More than 650 published studies, with 30 years of clinical Bone B experience Phase CP Our MBCP Technology microporosity macroporosity Biomatlante s Bone Scaffolds have evolved to meet new biotechnological requirements stemming from tissue engineering where surgeons need to combine scaffolds with biological fluids (bone marrow or mesenchymal stem cells) or active agents. Biomatlante leads the way in the development of synthetic bone scaffolds for use in numerous research programs biphasic seeking to improve outcomes for particularly challenging patients. 100 µm 2 µm calcium phosphate The performance of MBCP is characterized by: Equivalent clinical outcome to autologous bone graft; Fewer wound healing problems than autologous grafts; Avoidance of donor site pain and infections; No allergenic reactions 1. microporosity macroporosity Burden of Proof Level Title Authors 1 «Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.» (1998) A. O. Ransford, T. Morley, M. A. Edgar, P. Webb, N. Passuti, D. Chopin, C. Morin, F. Michel, C. Garin, D. Pries. Study Type Patients Number Prospective 341 Randomized & Controlled 3

4 microporosity macroporosity calcium phosphate biphasic Osteotwin ACL Fixation System Interference Screw Osteotwin was designed to fulfill two core aims: provide appropriate mechanical properties necessary for ligament reconstruction whilst ensuring a regulated resorption and osteointegration to form architectural bone through hydrolysis. Knee Cruciate Ligament Reconstruction Attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur Design The thread is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone. Lengths 25 & 30 Length 20 Screw tip tailored to assist insertion into the bone tunnel Specific design thread for optimal contact Smooth thread to minimize damage on ligament Graduated tapered design to optimize torque The conical tip is shorter to increase threaded screw contact Auto stopper half head design Headless to maximize the length of the screw Mineral Bone Phase M CP Bioactivity B Specific screwdriver connection design to provide optimal distribution of force The mean failure torque for Osteotwin is 6 N.m, whereas other leading implants show a breakage rate of 5 and 5,3 N.m*. 4

5 microporosity macroporosity calcium phosphate biphasic Polylactic & Composite Screws 75% PLDLLA Organic Matrix Polylactic Acid PLDLLA 100% PLDLLA Better balance between degradation and mechanical strength than PLGA or PLA DL-Lactide is amorphous (the crystallinity has been removed) which increases the resorption rate Polylactic Screw PLDLLA Only Mineral Bone Phase Bioactivity M B CP HA β-tcp Mineral Charge Biphasic Calcium Phosphate L-Lactide provides greater mechanical resistance MBCP Technology Promotes the scaffold effect for osteoconduction and osteogenesis during the resorption of the polymer by hydrolysis For bioactive ionic exchange: TCP dissolution and bony crystal precipitation. Newly bioactive interface with bone cells Composite Screw Optimal Balance Regeneration of architectural bone 25% MBCP Technology 75% PLDLLA & 25% BCP: the ideal ratio between the necessary mechanical resistance for the indication and the faculty to generate bone growth. KEY FEATURES KEY BENEFITS Biocompatible No rejection Bio absorbable Non obstructive, in event of revision Metal-like mechanical properties Necessary for indication requirements Polymer & Ceramic Bioactive 3 ph Neutral No reported cases of inflammation or kysts (out of 30,000 cases) Polylactic Screw Composite Screw Positive clinical response MBCP Technology Architectural bone growth Greater corticalization* 5

6 Osteotwin ACL Fixation System Affix Sheath Osteotwin Affix Sheath is an innovative and unique Tibial Fixation Device. Affix Sheath is designed to increase soft tissue fixation in ACL reconstruction surgery. Using Affix Sheath guarantees superior fixation strength* and greater graft protection. Design Interior threading can be used with both Polylactic and Composite screws Rotational locking system during screw insertion Guide wire friendly Self opening stabilization system Expandable Average Failure Average Loads Failure Loads Screw vs. Screw Screw + Sheath vs. Screw + Sheath Single Strand Single Strand 150% 150% Average Failure Average Loads Failure Loads Screw vs. Screw Screw + Sheath vs. Screw + Sheath Double StrandDouble Strand % 125% % % % % 125% % 100% 100% mm 7-8 mm 8 mm 97-8 mm mm 9-10 mm 9 mm 9-10 mm mm 7-8 mm 8 mm 7-8 mm Tested in a porcine tibia with human hamsting tendon* All screws lengths: 25 mm Easy & Safe 6

7 Osteotwin ACL Fixation System Product References Screws Diameter 7 mm 8 mm 9 mm 10 mm 11 mm 12 mm Length 20 mm 25 mm 30 mm Composite 11CPVI CPVI CPVI Polylactic 13PVI PVI PVI Composite 08CPVI CPVI CPVI CPVI1025 Polylactic 13PVI PVI PVI PVI1025 Composite 08CPVI CPVI CPVI CPVI1030 Polylactic 13PVI PVI PVI PVI mm Composite 15CPVI1135* 15CPVI1235* * Coming soon Sheaths Reference 7-8 mm 14CPCH mm 14CPCH0925 Class III Medical Device According to EU Directive EEC/93/42 7

8 Osteotwin ACL Fixation System Instrumentation Osteotwin Intrumentation Kits have been developed with two main goals in mind: insure the quality of surgical procedures with dedicated high quality tools; and save you time during surgical procedures with color coding. These Instrumentation Kits are fully customizable. Osteotwin Kits Sheath Instrumentation Screw Modular System Screw Classic System Screw Dilator System Modular Screw System 14INPO001 14INTO001 14INTA001 Rachet Handle Screwdriver Shaft Starter Tap Shaft 8

9 Classical Screw System 11INTA001 08INTO001 Starter Tap Screwdriver Dilator Screw System 08INCO001 Tunnel Dilator Screw Sheath Instrumentation 14INDI001 14ININ001 Dilator Sheath Inserter Sheath 9

10 Osteotwin High Tibial Osteotomy MBCP Wedges High Tibial Osteotomy MBCP Wedges are designed to precisely fit within the shape of the opened wedge correction. Made of MBCP, the reference in osteoconductive bone graft substitute, they are a biphasic calcium phosphate made of 60% hydroxyapatite (HA) and 40% Beta-Tricalcium Phosphate (ß-TCP), allowing for simultaneous controlled adsorption and promotion of osteogenesis. Controlled resorption, osteogenic and osteoconductive Custom design Standard design 20 years of proven efficacy While MBCP Wedges have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems.* Biomatlante recommends these HTO plate specialists: 10

11 Osteotwin References & Bibliography MBCP Technology 1. A.O. Ransford et al., Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients. J Bone Joint Surg Br, (1): F. Gouin, J. Delecrin, N. Passuti, S. Touchais, P. Poirier, J. Bainvel Biphasic macroporous calcium phosphate ceramic bone substitute for filling bone defects: A report of 23 cases. Revue de Chirurgie Orthopedique: 81; (1995). 3. G. Daculsi, P. Corlieu, M. D Arc, M. Gersdorff Macroporous biphasic calcium phosphate efficiency in mastoid cavity obliteration: experimental and clinical findings. Annals of Otology, Rhinology & Laryngology: 101 (8); (1992). 4. G. Daculsi, N. Passuti, S. Martin, C. Deudon, R. Legeros, S. Raher Macroporous calcium phosphate ceramic for long bone surgery in humans and dogs. Clinical and histological study. Journal of Biomedical Materials Research: 24; (1990). 5. G. Daculsi, F. Jegoux, an P. Layrolle (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 * Data on files, Biomatlante Osteotwin 1. Daculsi, G., O. Laboux, et al. (2003). «Current state of the art of biphasic calcium phosphate bioceramics.» Journal of Materials Science: Materials in Medicine 14(3): Middleton, J. C. et al.; Biomaterials 21 (23), «Synthetic biodegradable polymers as orthopedic devices», Suchenski, M., M. B. McCarthy, et al. (2010). «Material Properties and Composition of Soft-Tissue Fixation.» The Journal of Arthroscopic and Related Surgery 26(6): Uzel, A. P., E. Seris, et al. (2013). «Preclinical and clinical cases of new absorbable composite interference screws in osteoarticular surgery.» Key Engineering Materials : Kaeding, C., J. Farr, et al. (2005). «A Prospective Randomized Comparison of Bioabsorbable and Titanium Anterior Cruciate Ligament Interference Screws.» The Journal of Arthroscopic and Related Surgery 21(2): Hunt, J. A. and J. T. Callaghan (2008). «Polymer-hydroxyapatite composite versus polymer interference screws in anterior cruciate ligament reconstruction in a large animal model.» Knee Surgery, Sports Traumatology, Arthroscopy 16(7): Weiler, A., H. J. Windhagen, et al. (1998). «Biodegradable interference screw fixation exhibits pull-out force and stiffness similar to titanium screws.» The American journal of sports medicine 26(1): Weiler, A., R. F. Hoffmann, et al. (1998). «Hamstring tendon fixation using interference screws: a biomechanical study in calf tibial bone.» Arthroscopy: The Journal of Arthroscopic and Related Surgery 14(1): Black, J., (1988). «Does corrosion matter?» The Journal of Bone and Joint Surgery, 70-B(4): Bauer, J., Turgay, E., et al. (2010)., «Torsional stability of interference screws derived from bovine bone - a biomechanical study.» BMC Musculoskeletal Disorders 11: Uzel, P. A., G. Daculsi, et al, «Utilisation des coins de MBCP en traumatologie lors des fractures enfoncement (tibia proximal et distal, calcanéum) : double intérêt de comblement et d étayage», 13ème Congrès de l AOLF (2012) 12. R. Schouten, G. Hooper, The use of Bone substitute (Triosite) wedges in Medial Opening wedge high tibial osteotomies, 33 Patient clinical study, Journal of Bone & Joint Surgery, British Volume (2009) 13. Rouvillain, J.L., Lavalle, F., Pascal-Mousselard, H., Catonne, Y., Daculsi, G., Clinical, radiological and histological evaluation of biphasic calcium phosphate bioceramic wedges filling medial high tibial valgisation osteotomies., Knee (2009) 14. Rouvillain, J. L., Pascal-Mousselard, H., Lavalle, F, Garron E., Catonné Y., Daculsi G., MBCP Wedges performance during open medial tibial osteotomy, European conference on biomaterials (2006) 15. Lavallé, F., H. Pascal-Mousselard, et al, Biphasic ceramic wedge and plate fixation with locked adjustable screws for open wedge tibial osteotomy, Revue de chirurgie orthopédique (2004) * Data on files, Biomatlante Notes 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. Osteotwin & MBCP are trademarks of Biomatlante, SA. This document is not applicable for the US. 11

12 Biomatlante Backed by 20 years of experience in the development and manufacturing of synthetic bone substitutes, Biomatlante readily meets the challenge of constantly evolving its product line to meet today s market demands for new, more effective, generations of biomaterials and smart scaffolds for tissue regeneration and minimally invasive surgical technologies. Our Values Commitment We are committed to our industry we feel we have a bond with physicians and patients alike. Integrity We treat people fairly and expect the same in return. Quality We are committed to providing products of the highest quality We never compromise! Passion We love what we do. Innovative bone regeneration solutions are truly our passion. BIOMATLANTE 5 rue Édouard Belin Z.A. Les Quatre Nations Vigneux-de-Bretagne France +33 (0) contact@biomatlante.com Biomatlante All rights reserved Last Update: May 2015 FT MO1