Spine SurgeryProduct Line

When Innovation Meets Performance

eXperts in bone regeneration

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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.

At the core of all our products:Our proprietary MBCP™ Technology

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.11 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): 13-8.

macroporosity

microporosity

100 µm2 µm

Sector: SpineIndication: Posterolateral fusionStudy Type: Clinical studyNumber of Patients: 58Product: 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)

1 month 6 months 1 year

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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.

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Spine Surgery Line

Interbody fusion Posterolateral fusion

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.

MBCP™ InsertsCervical & Lumbar cages

MBCP™ Sticks

MBCP™ Syringe

MBCP™ GelTrabecular cages

In’Oss™Cervical Cages

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In’Oss™ Line of Moldable Synthetic Bone Graft

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.

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.

• Excellent handling characteristics• Ready to use

• Moldable• Resorbable

• Volume stability

Product Benefits

Syringe0.5mL & 1mL

INTERBODY FUSION

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

• 100% synthetic

• Fast Bone Ingrowth

• Injectable

4 months bone remodelling with haversian system - Goat model

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• Injectable

MBCP™ Inserts Interbody cervical and lumbar fusion

+ =

• Easy handling

• Make your cages stand out, unique cage and bespoke insert

• Resorbable

• Quicker procedure

Product Benefits

INTERBODY FUSION

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.

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.

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MBCP™ Syringe

MBCP™ Sticks

100% Synthetic:

• 60% HA (Hydroxyapatite)

• 40% β-TCP (Tricalcium Phosphate Beta)

Global interconnected porosity of 70%:

• 2/3 of macropores (>10µm)

• 1/3 of micropores (<10µm), due to a unique know-how

High Quality Bone Graft

POSTEROLATERAL FUSION

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

2. Remove the cap of MBCP™ Syringe and easily extrude the material by pushing the plunger.

Syringe5cc & 10cc

Passuti, N., (1989) « Macroporous calcium phosphate ceramic performance in human spine fusion » Clin Orthop (248),

Spinal Fusion with MBCP™

5 year follow up

Spine 2000 (25), J Delécrin « A synthetic porous ceramic as a bone graft substitute in the surgical treatment of scoliosis »

MBCP™ sticks are mostly used in association with autograft for posterolateral graft.

1/3 of MBCP™ Sticks

2/3 of autologous bone

MBCP™ Sticks have been shown to be effective in lumbar posterior fusion.

SticksLarge variety available

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Notes

Manufacturer: BIOMATLANTE • 5 rue Édouard Belin • Z.A. Les Quatre Nations • 44360 Vigneux-de-Bretagne • France www.biomatlante.com • contact@biomatlante.com • +33 (0)2 28 02 00 09

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Bibliography

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): 13-8.

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; 59–65.

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); 669–674.

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; 379–396

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 101-141

Delécrin, J. (2000) «A synthetic porous ceramic as a bone graft substitute in the surgical treatment of scoliosis» Spine (25)

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)::3295-305

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

Human Maxillo-Facial Surgery, Key Engineering Marerials Vols. 284-286 pp. 1053-1056

Catherine, A., Davy, O. Gauthier, and al. (2004) Assessment of Cancellous Bone Architecture after Implantation of an Injectable Bone Substitute,, Key Engineering Materials Vols. 254-256 pp. 55-5842

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. 361-363 pp. 1295-1298

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. 284-286, pp.803-806

Weiss, P., Clergeau, L.P., Enckel, B., Amouriq, Y., Giumelli, B., Jean, A., Daculsi, G., (2005)

A New Injectable Bone Substitute Concept (MBCP Gel ™): First Clinical Results in Human Maxillo-Facial Surgery, Key Engineering Materials Vols. 284-286 pp. 1053-1056

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 395-4242

Davy, A., Gauthier, O., and al. (2004) Assessment of Cancellous Bone Architecture after Implantation of an Injectable Bone Substitute, Catherine., Key Engineering Materials Vols. 254-256 pp. 55-5842

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. 361-363 pp. 1295-1298

MBCP™ Technology

MBCP™ Gel

In’Oss™

• 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.

Notes

About BiomatlanteBased 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.