Dyneema Purity® fiberWorld strongest medical grade fiber used inmillions of patients today!

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• Active worldwide in performance materials & life sciences• Among global leader in approximately 75% of businesses• History of 100+ years. Highly ranked in Dow Jones Sustainability Index• Focus on growth by means of innovation

DSM Company profile

DSM key dataSales ~ Euro 8200 mlnEBIT ~ Euro 750 mlnWorkforce ~ 22000 (9% R&D)Material research > 300 people

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Examples of business areas

Anti-infectives

Food

Pharmaceutics

Electronics

Automotive

Constructions

Biomedical materials

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Dyneema Purity® fiber for medical use

Strong, thin and pliable sutures play animportant role in rotator cuff repair1:

Minimizes suture breakage during tightening

Reduces need for additional proceduresReduces patient discomfort

Switch to Dyneema Purity® fiber

High strength sutures made with Dyneema Purity®

have become the new ‘golden’ standard within 4years.

1Oper Tech Sports Med 12:210-214 (2004)

CASE: Rotator cuff repair

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CASE: ACL repair

Switch to Dyneema Purity® fiber

Various constructions of Dyneema Purity®

are used today to secure the soft tissuetransplant, providing strength andstiffness.

Fixation of ligament replacement in kneeEndoscopic, minimally invasive procedureReduces patient discomfort and costs

Strength and compliance essential

Dyneema Purity® fiber for medical use

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Orthopedic segmentsHigh strength sutures

ACL repair

Laminar wiring fusion (spine)

Non fusion (spine)

Scoliosis (spine)

ACL replacement

Cerclage cables (trauma)

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Cardiovascular segments

Stent grafts

Catheters

CV Sutures

Heart valves

Stimulation leads

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The basics

• Dyneema Purity® fiber is made from Ultra HighMolecular Weight Polyethylene (UHMWPE), witha very high purity, dedicated for medicalapplications

Normal Polyethylene, low orientation, lowmolecular weight, crystalinity < 60%

Dyneema Purity® fiber, very high molecularorientation and weigth, crystalinityapproximately 95%

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Extremelystrong

Soft as silk

High fatigueresistance

Low density

High abrasionresistance

Biocompatible;low irritation rate

High chemicalresistance

Low meltingpoint (~150°C)

Creeps underconstant load

Cut and tearresistance

Highpliability

Low coefficientof friction

Electricalinsulator

Hydrophobic

Lowelongation

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Benchmarking strength - IN/tex

Tenacity based on volume1

1

2

2

3

3

4

4

Nylon

Titanium Steel

Aramids

Carbon

BoronCeramic

1

1

2

2

3

3

4

4

Nylon

PET

Steel

Aramids

Carbon

Ceramic

Tena

city

bas

ed o

n w

eigh

t

N/tex

GPa

Dyneema Purity® fiber

PPePTFE

At similar weight,Dyneema Purity® fiberis about 15x strongerthan steel.

At similar volume,Dyneema Purity® fiberis about 4x strongerthan titanium

At similar volume,Dyneema Purity® fiberis about 3x strongerthan polyester

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Benchmarking strength - II

Benchmark with other fibermaterials commonly used inmedical devices shows theunique stress-strain behaviorof Dyneema Purity® fiber.

Dyneema Purity® fiberPolyester (PET) fiberNylonPolypropylene (PP)

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Benchmarking size

USP#2 suture madewith Dyneema Purity®

fiber

USP#5 Ethibond Excel™polyester suture

Two constructions with similar strength,23x magnification (SEM micrograph)

Profile reduction at same strength

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Benchmarking fatigue resistance

Analyzed in a tensile test set-up with a frequency of 2 Hz

Conclusion

Dyneema® fibers will not easilybreak or lose their strength whensubjected to cyclic or fluctuatingloads.

Test setup

Hydraulic machine0.3Hz cyclic loadsData filed at DSM

Tension fatigue testing at similar relative loading

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Conformity

• Polyethylene cables conform tobone surfaces. Metal cableshave a narrow contact surfaceand hence show high focalloads. Focal loads can causecables to cut through bone2.

• Polyethylene cables flattenwhen placed under tension.This property may make the usemore desirable for soft,osteoporotic or cartilaginousbone (i.e. in elderly or youngchildren)2.

2From SPINE, Volume 22, Nr. 6, pp. 596-604, 1997:

Dyneema® filament stretchedover the edge of a razorblade (SEM)

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Abrasion resistance - IAbrasion resistance of sutureTest set-up:

Test details:– Dyneema Purity® UG vs. polyester;– USP#2 sutures with core-sheath construction;– Hard steel pins with 0.9mm;– Sutures tensioned at 2% of their MBL (max. breaking

load);– Frequency: 114 cycles/min.

0

10000

20000

30000

40000

50000

60000

70000

UG Polyester

# C

ycle

s-to

-bre

ak

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Coefficient of friction

Coefficient of friction - ASTM D3108 yarn on metalStandard Test Method for Coefficient of FrictionYarn to Solid Material, load 22.2 mN/tex

00,050,100,150,200,250,300,35

DyneemaPurity® SGX fiber

Aramid Polyester Polyamide PTFE

Coe

ffici

ent o

f fric

tion

dry

wet

• Low coefficient of friction contributes to ‘soft touch’, silky feeling.• Because of its low coefficient of friction, products made with Dyneema Purity®

fibers slide more easily through tissue.

Data filed at DSM

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Stopping power• Dyneema Purity® fiber has a very low elongation:

– Elongation at break typically is around 3-4% whereas elongation of PETtypically is around 15-20%.

– Dyneema Purity® fiber is used in medical applications for its stopping powerneeded to prevent dimensions or structures go beyond a pre-specified range.

– Modulus of Dyneema Purity® fiber is 130N/tex or 126GPa

• Low elongation can be used to improve tactilefeedback for surgeon or patient.

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ISO10993

x: applicable biological tests

o: optional biological testsMaster File on Dyneema Purity®fibers available at FDA

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Chemical resistance

Ultra High Molecular Weight Polyethylene

95% crystalline

No chemical groups

Hydrophobic (Surface tension 27 mN/m)

Very resistant against chemicals

90-100 %500020100Distilled water

Others

500020100Trichloromethane

500020100Acetone

90-100 %500020100Ethanol

Organic solvents

50002010NaOH

90-100 %168600.25Ca(OH)2

Bases

90-100 %500020100CH3COOH

Organic acids

168600.24H2SO4

50002010HNO3

90-100 %50002010HCl

Inorganic acids

Exp. time[hr]

Temp.[ºC]

Conc. [%]

Tensilestrengthretention

ConditionsChemical

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Sterilization

Preferred sterilization method for Dyneema Purity® fiber is EtO:

EtO and steam sterilization hardly affects the mechanical strength.Steam should be avoided because Dyneema Purity® fiber is sensitive to too high temperatures.

Gamma- and e-beam sterilization significantly reduce the mechanical strength due to chain scission.Sterilization-induced oxidation might be partly prevented by sterilizing in N2.

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Today, more than 10.000.000 patients have medicaldevices with Dyneema Purity® fiber in their body.

How can Dyneema Purity® fiberenable you in your next generationdevice design?

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Thank you!

www.dyneemapurity.comDyneema® and Dyneema Purity® are registered trademarks of Royal DSM N.V.

All information supplied by or on behalf of DSM Dyneema LLC and/or DSM Dyneema BV (“DSM”) in relation to its products, thecharacteristics and properties of its products and their possible application, whether in the nature of data, recommendations orotherwise, is supported by research and/or experience and believed reliable, but DSM gives no warranties of any kind, expressed orimplied, including, but not limited to, those of correctness, completeness, merchantability or fitness for a particular purpose and DSMassumes no liability whatsoever in respect of application, processing, use of, or reliance on, the aforementioned information or products,or any consequence thereof, including but not limited to any infringement of the rights owned or controlled by a third party regardingintellectual, industrial or other property. Any information provided by DSM does not release the user from the obligation to verify suchinformation and to perform its own testing and analysis to determine the suitability of the products for the intended process, use orspecific application. The user accepts all liability in respect of or resulting from the application, processing, use of, or reliance on, theaforementioned information or products or any consequences thereof.