experts in bone regeneration Osteotwin Sports Surgery Line

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1 experts in bone regeneration Sports Surgery Line

2 About 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. 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 smart scaffolds for use in numerous research programs seeking to biphasic 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 spinal wound healing problems than autologous grafts; Avoidance of donor site pain and infections; No allergenic reactions. microporosity macroporosity MBCP Technology: worldwide reference in synthetic bone graft Mineral Bone Phase Mmicroporosity macroporosity CP calcium phosphate Bioactivity B biphasic

3 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 Canulated Screw Design The thread is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone. Screw tip tailored to assist insertion into the bone tunnel Atraumatic thread for optimal contact The conical tip is shorter to increase threaded screw contact Non aggressive thread (to protect the ligament) Lengths 25 and 30 Auto stopper half head design Graduated tapered design to optimize torque Headless to maximize the length of the screw Length 20

4 ACL Fixation System Polylactic Screws Made of amorphous PLDLLA, Osteotwin Polylactic reduces inflammation risk. Organic Matrix Polylactic Acid Composite Screws 75% PLDLLA & 25% BCP: the ideal ratio between the necessary mechanical resistance for the indication and the faculty to generate bone growth. Organic Matrix Polylactic Acid Mineral Charge Biphasic Calcium Phosphate (BCP) Granules 75% PLDLLA Better balance between degradation and mechanical 8, 9, 10 strength than PLGA or PLA L-Lactide provides greater mechanical resistance DL-Lactide is amorphous (the crystallinity has been removed) which increases the resorption rate 25% MBCP Technology Promotes the scaffold effect for osteoconduction and osteogenesis during the resorption of the polymer by hydrolysis 4 For bioactive ionic exchange: TCP dissolution and bony crystal precipitation. Newly bioactive interface with bone cells Regeneration of architectural bone KEY FEATURES KEY BENEFITS Polymer & Ceramic Bioactive 3 Composite Screw Polylactic Screw ph Neutral Positive clinical response MBCP Technology Biocompatible Bio absorbable Metal-like mechanical properties No reported cases of inflammation. No reported cases of kysts.* Architectural bone growth Greater corticalization* No rejection Non obstructive, in event of revision Necessary for indication requirements * 30,000 cages

5 Product References Screws Diameter 7 mm 8 mm 9 mm 10 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 PVI1030 Instruments Screwdriver Screwdriver Shaft 1 Screwdriver Shaft 2 Screwdriver Shaft 3 Nitinol Guide Wire Rachet Handle Tap Shaft Tap Dilator 07/08 - Sheath Dilator 07/08 - Screw Dialtor 09/10 - Sheath Dilator 09/10 - Screw Bioactivity Introductor 07/08 - Sheath Introductor 09/10 - Sheath M Mineral Bone B Phase Osteotwin Sheath Instrumentation Tray CP 14INBT003 Osteotwin Instrumentation Tray Osteotwin Screw Instrumentation Tray microporosity macroporosity calcium phosphate biphasic 14INBT001 14INBT002 Empty Tray 14INBT004 Consult instructions for use Class III Medical Device According to EU Directive EEC/93/42 Certain products may not be approved for sale in all countries Supplied sterile ISO 13485

6 ACL Fixation System Affix Sheath Osteotwin Affix is a new and unique Tibial Fixation Device from Biomatlante. Affix is designed to provide soft tissue fixation in ACL reconstruction surgery. Using Affix guarantees superior fixation strength and greater graft protection. Osteoconductive Scaffold 75% PLDLLA & 25% BCP the ideal ratio between mechanical resistance and the faculty to generate bone growth. Innovative & Expandable Guide wire friendly Self opening stabilization system Interior threading can be used with most screws on the market Rotational locking system during screw insertion Easy & Safe

7 Instrumentation Ancillary Osteotwin Tray Sheath Instrumentation Screw Modular System Screw Monoblock System Torx Screwdriver Torx Screwdriver 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*. Other Instruments Starter Tap Tunnel Dilator Guide Wire

8 ACL Fixation System Loop Femoral Fixation Plate with loop Loop is your implant of choice used to secure soft tissue grafts to bone during cruciate ligament reconstruction. Combined with a traditional surgical technique, Loop implant provides strength and security. Loop Intended for use in tendodesis procedures with soft tissue graft (arthroscopic or open techniques) during Anterior & Posterior Cruciate Ligaments, Medial & Lateral Collateral Ligaments and Medial Patellofemoral Ligament for knee reconstruction. Tightly woven and pre-stretched to remove creep prior to implantation Integrated method to reposition the implant Pre-loaded with passing sutures High resistance (608.9 N) Product Benefits Simple technique Inherent Rotational Moment (IRM) for effective seating on femoral cortex Lenght

9 High Tibial Osteotomy MBCP Wedges Bioactive Osteotomy Wedges Bone Graft Substitute 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. While MBCP Wedges have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems. Controlled resorbtion and Custom design Standard design 20 years of proven efficacy Biomatlante recommends these HTO plate specialists:

10 References 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) 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) 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) 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) 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

11 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. ISO Read the instructions for use BIOMATLANTE 5 rue Édouard Belin Z.A. Les Quatre Nations Vigneux-de-Bretagne France +33 (0) contact@biomatlante.com Biomatlante Last Update: February 2015 FT2015xxxx