eXperts in bone regeneration

Osteotwin™

Sports Surgery Line

When Innovation Meets Performance

3

Burden of Proof

Mineral

BonePhase

Bioactivity

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

Sports Surgery Line

Our MBCP™ Technology

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.

More than 650 published studies, with 30 years of clinical experience

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

seeking to improve outcomes for particularly challenging patients.

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 reactions1.

macroporosity

microporosity

100 µm2 µm

Level Title AuthorsStudy Type

Patients Number

Randomized & Controlled

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. Pas-suti, D. Chopin, C. Morin, F. Michel, C. Garin, D. Pries.

Prospective 341

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Osteotwin™

Interference ScrewOsteotwin™ 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.

Design

The thread is specific to each screw diameter so as to systematically provide the maximum amount of contact between implant and bone.

Specific design thread for optimal contact

Smooth thread to minimize damage on ligament

Graduated tapered design to optimize torque

Screw tip tailored to assist insertion into the bone tunnel

Auto stopper half head design

The conical tip is shorter

to increase threaded

screw contact

Length 20Lengths 25 & 30

Headless to maximize

the length of the screw

ACL Fixation System

Knee Cruciate Ligament Reconstruction Attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur

Specific screwdriver connection design to provide optimal distribution of forceThe mean failure torque for Osteotwin™ is 6 N.m, whereas other leading implants show a breakage rate of 5 and 5,3 N.m*.

Mineral

BonePhase

Bioactivity

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

5

Co

mp

osite S

crewPolylactic & Composite Screws

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 Bioactive3

pH Neutral No reported cases of inflammation or kysts (out of 30,000 cases)

Positive clinical response Architectural bone growth

MBCP™ Technology Greater corticalization*

Organic MatrixPolylactic Acid

Mineral ChargeBiphasic Calcium Phosphate

Polylactic ScrewPLDLLA Only

75%

PLD

LLA

MBCP™ Technology

PLDLLA

25% MBCP™ Technology

Composite ScrewOptimal BalanceOp

Promotes the scaffold effect for osteoconduc-tion 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

Regeneration of architectural bone

Better balance between degradation and mechanical 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

100% PLDLLAMineral

BonePhase

Bioactivity

HA β-TCP

MB

CPmicroporositymacroporosity

calciumphosphate

biphasic

Po

lylacticS

crew

6

Osteotwin™ ACL Fixation System

Affix Sheath

Affix Sheath is designed to increase soft tissue fixation in ACL reconstruction surgery. Using Affix Sheath guarantees superior fixation strength* and greater graft protection.

Tested in a porcine tibia with human hamsting tendon* All screws lengths: 25 mm

Osteotwin™ Affix Sheath is an innovative and unique Tibial Fixation Device.

Easy & Safe

Design

Rotational locking system during screw insertion

Guide wire friendly

125%

100%

150%

+24.45%+30.33%

8 mm 7-8 mm 9 mm 9-10 mm

Average Failure LoadsScrew vs. Screw + Sheath

Single Strand

125%

100%

150%

+24.45%

+54.87%

7 mm 7-8 mm 8 mm 7-8 mm

Average Failure LoadsScrew vs. Screw + Sheath

Double Strand

296 420 273 413326 400 500 651

125%

100%

150%

+24.45%+30.33%

8 mm 7-8 mm 9 mm 9-10 mm

Average Failure LoadsScrew vs. Screw + Sheath

Single Strand

125%

100%

150%

+24.45%

+54.87%

7 mm 7-8 mm 8 mm 7-8 mm

Average Failure LoadsScrew vs. Screw + Sheath

Double Strand

296 420 273 413326 400 500 651

Expandable

Self opening stabilization system

Interior threading can be used with both Polylactic and Composite screws

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Product References

Osteotwin™ ACL Fixation System

Class III Medical Device According to EU Directive EEC/93/42

Screws

Sheaths

7 mm 8 mm 9 mm 10 mm 11 mm 12 mm

20 mmComposite 11CPVI0720 11CPVI0820 11CPVI0920 -

Polylactic 13PVI0720 13PVI0820 13PVI0920 -

25 mmComposite 08CPVI0725 08CPVI0825 08CPVI0925 12CPVI1025

Polylactic 13PVI0725 13PVI0825 13PVI0925 13PVI1025

30 mmComposite 08CPVI0730 08CPVI0830 08CPVI0930 08CPVI1030

Polylactic 13PVI0730 13PVI0830 13PVI0930 13PVI1030

35 mm Composite 15CPVI1135* 15CPVI1235*

Length

Diameter

Reference

7 - 8 mm 14CPCH0725

9 - 10 mm 14CPCH0925

* Coming soon

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Osteotwin™ ACL Fixation System

Instrumentation

Modular Screw System

Osteotwin™ Kits

Sheath Instrumentation

Screw Modular System

Screw Classic System

Screw Dilator System

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.

Rachet Handle Screwdriver Shaft Starter Tap Shaft

14INPO001 14INTO001 14INTA001

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Classical Screw System

Dilator Screw System

Sheath Instrumentation

Dilator Sheath Inserter Sheath

Tunnel Dilator Screw

08INCO001

14INDI001

Starter Tap

11INTA001

14ININ001

Screwdriver

08INTO001

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Osteotwin™ High Tibial Osteotomy

MBCP™ Wedges

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.

Biomatlante recommends these HTO plate specialists:

Controlled resorption, osteogenic and osteoconductive

Custom design — Standard design

20 years of proven efficacy

High Tibial Osteotomy MBCP™ Wedges are designed to precisely fit within the shape of the opened wedge correction.

While MBCP™ Wedges have a high compressive force of 10-12MPa, they are intended for use with rigid fixation systems.*

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Osteotwin™ References & Bibliography

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): 195-200.

2. Middleton, J. C. et al.; Biomaterials 21 (23), «Synthetic biodegradable polymers as orthopedic devices», 2000 2335-2346.

3. Suchenski, M., M. B. McCarthy, et al. (2010). «Material Properties and Composi-tion of Soft-Tissue Fixation.» The Journal of Arthroscopic and Related Surgery 26(6): 821-831.

4. Uzel, A. P., E. Seris, et al. (2013). «Preclinical and clinical cases of new absor-bable composite interference screws in osteoarticular surgery.» Key Enginee-ring Materials 529-530: 325-330.

5. 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): 147-151.

6. 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): 655-660.

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): 119-126.

8. Weiler, A., R. F. Hoffmann, et al. (1998). «Hamstring tendon fixation using inter-ference screws: a biomechanical study in calf tibial bone.» Arthroscopy: The Journal of Arthroscopic and Related Surgery 14(1): 29-37.

9. Black, J., (1988). «Does corrosion matter?» The Journal of Bone and Joint Surgery, 70-B(4): 517-520.

10. Bauer, J., Turgay, E., et al. (2010)., «Torsional stability of interference screws derived from bovine bone - a biomechanical study.» BMC Musculoskeletal Disorders 11: 82

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., Clini-cal, radiological and histological evaluation of biphasic calcium phosphate bio-ceramic 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 fixa-tion with locked adjustable screws for open wedge tibial osteotomy, Revue de chirurgie orthopédique (2004)

* Data on files, Biomatlante

1. A.O. Ransford et al., “Synthetic porous ceramic compared with autograft in sco-liosis surgery. A prospective, randomized study of 341 patients.” J Bone Joint Surg Br, 1998. 80(1): 13-8.

2. F. Gouin, J. Delecrin, N. Passuti, S. Touchais, P. Poirier, J. Bainvel “Biphasic macroporous calcium phosphate ceramic bone substitute for filling bone de-fects: A report of 23 cases.” Revue de Chirurgie Orthopedique: 81; 59–65 (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); 669–674 (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; 379–396 (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 101-141

* Data on files, Biomatlante

• 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.

Notes

MBCP™ Technology

Osteotwin™

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.

Biomatlante

Commitment We are committed to our industry – we feel we have a bond with physicians and patients alike.

Our Values

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!

PassionWe love what we do. Innovative bone regeneration solutions are truly our passion.

BIOMATLANTE5 rue Édouard Belin

Z.A. Les Quatre Nations44360 Vigneux-de-Bretagne

France

+33 (0)2 28 02 00 09contact@biomatlante.com

www.biomatlante.com

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