A world class portfolio of Biomedical Materials

Solutions for Medical Implants

MEDICAL IMPLANTS Go back millennia

Oldest Implant? Neolithic cemetery near Gebel Ramlah, Egypt 5500 years ago Implant material: Red Sea shell

Neolithic cemetery near Gebel Ramlah, Egypt

5500 years ago

Implant material: Red Sea shell

First suture? Pharaonic Egypt: Medicine practices described in Smith Papyrus First suture: linen thread with copper needle

Pharaonic Egypt: Medicine practices described in Smith Papyrus

First suture: linen thread with copper needle

20th century: Revolution in Implants Multitude of implants made from metals, natural products and synthetic polymers

Multitude of implants made from metals, natural products and synthetic polymers

Orthopedics Orthopedics has been a major focus area for implants Requiring strong and durable materials

Orthopedics has been a major focus area for implants

Requiring strong and durable materials

Orthopedics Orthopedics becomes more important With an aging community, more active lifestyles, and obesity All lead to more frequent and more complex orthopedic surgeries

Orthopedics becomes more important

With an aging community, more active lifestyles, and obesity

All lead to more frequent and more complex orthopedic surgeries

Orthopedics Orthopedics is a lot like “Mechanical Engineering” Correcting structural elements when they are broken

Orthopedics is a lot like “Mechanical Engineering”

Correcting structural elements when they are broken

Orthopedic Devices Bridging the gap between tissues Orthopedic surgical procedures require advanced implants Implants that close the gaps between separated tissues Orthopedics

Orthopedic surgical procedures require advanced implants

Implants that close the gaps between separated tissues

Orthopedic Devices Bridging the gap between tissues Elastomeric / Shock Absorption material Wear Resistance / Surface Bearing Material Rigid Construction Material Strong Fiber for Suspension 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Elastomeric / Shock Absorption material Wear Resistance / Surface Bearing Material Rigid Construction Material Strong Fiber for Suspension 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Strong Fiber for Suspension 4 Material Segments

World's strongest fiber™ Ligaments: 50 – 105 MPa Hair: 190 MPa Bone: 120 – 150 MPa … is soft as silk Spider Silk: 1400 MPa Dyneema Purity ® : 3000 MPa

The gold standard in rotator cuff repair Pictures provided by

Orthopedic Devices Bridging the gap between tissues Strong Fiber for Suspension 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Wear Resistance / Surface Bearing Material 4 Material Segments

Surface Bearing - UHMwPE DSM is a major manufacturer of UHMwPE- Polyethylene, with a unique product / process technology Batch process which enables unique molecular architectures Process technology developed for high quality and high purity products deformation resistant wear & fatigue resistant high purity

DSM is a major manufacturer of UHMwPE-

Polyethylene, with a unique product / process

technology

Batch process which enables unique molecular architectures

Process technology developed for high quality and high purity products

UHMwPE Activities - Overview Developing our next generation optimized UHMwPE Easy cross-linkable material Offering various processing/application technologies for custom development Proprietary HALS stabilization technology First generation UHMwPE Homopolymer MG003 available currently being tested by major orthopedic companies.

Developing our next generation optimized UHMwPE

Easy cross-linkable material

Offering various processing/application technologies for custom development

Proprietary HALS stabilization technology

First generation UHMwPE Homopolymer MG003 available

currently being tested by major orthopedic companies.

Orthopedic Devices Bridging the gap between tissues Wear Resistance / Surface Bearing Material 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Elastomeric / Shock Absorption material 4 Material Segments

Elastomeric Materials Leader in Polyurethanes Extensively tested, long-term implantable biomedical polyurethanes Unmatched biocompatibility for chronic implants Unique combination of outstanding strength and flexibility Comprehensive FDA Master Files Specialty polymer design and process development (SAME ® ) Biomedical Polyurethanes Durable Biostable Biocompatible Abrasion Resistant

Extensively tested, long-term implantable biomedical polyurethanes

Unmatched biocompatibility for chronic implants

Unique combination of outstanding strength and flexibility

Comprehensive FDA Master Files

Specialty polymer design and process development (SAME ® )

Durable

Biostable

Biocompatible

Abrasion Resistant

DSM Biomedical Polyurethanes Some of the most extensively tested polymers for chronic implants Bionate ® polycarbonate-urethane Excellent mechanical strength; good oxidative stability; abrasion resistant PurSil ® silicone-polyether-urethane Aromatic or aliphatic versions Outstanding elasticity; non-adhesive silicone surface; thromboresistant; hydrolytically stable CarboSil ® silicone-polycarbonate-urethane Excellent flexibility; hydrophobic; thromboresistant; good oxidative stability Elasthane™ polyether-urethane Excellent Strength; low extractables; high molecular weight; hydrolytically stable BioSpan ® segmented polyurethane Excellent flexibility; hydrolytically stable For dipping, spinning, casting or spraying applications

Bionate ® polycarbonate-urethane

Excellent mechanical strength; good oxidative stability; abrasion resistant

PurSil ® silicone-polyether-urethane

Aromatic or aliphatic versions

Outstanding elasticity; non-adhesive silicone surface; thromboresistant; hydrolytically stable

CarboSil ® silicone-polycarbonate-urethane

Excellent flexibility; hydrophobic; thromboresistant; good oxidative stability

Elasthane™ polyether-urethane

Excellent Strength; low extractables; high molecular weight; hydrolytically stable

BioSpan ® segmented polyurethane

Excellent flexibility; hydrolytically stable

For dipping, spinning, casting or spraying applications

DSM TPE Medical New Material development in Elastomer Portfolio Unique, patented block - copolymer platform Combining hard polyester with soft polycarbonate Hard block (crystalline) – gives strength Soft segment (amorphous) – gives flexibility Improved Creep performance Co-moldable with DSM Rigid Platform Molecular equivalent of chain-link fence

Unique, patented block - copolymer platform

Combining hard polyester with soft polycarbonate

Hard block (crystalline) – gives strength

Soft segment (amorphous) – gives flexibility

Improved Creep performance

Co-moldable with DSM Rigid Platform

Orthopedic Devices Bridging the gap between tissues Elastomeric / Shock Absorption material 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Rigid Construction Material 4 Material Segments

DSM Rigid Concept New material development SYNERGY: DSM Rigid and DSM TPE are co-moldable and will form strong bonds Optimize all functionalities by combination of 4 building blocks Fibers Potential Reinforcement to tune the strength and stiffness to exactly the values necessary TPE Medical Toughening agent – will remove brittleness, introduced by adding particulates Osteoconductivity Inducer Potential adding of particulates to enhance bone adhesion DSM Rigid Our polyester base material, providing the material backbone

DSM Rigid New material development DSM Rigid platform compared to PEEK offers: Sufficient strength – properties even closer to bone Higher toughness Improved processability, better flow @ lower temperatures Hard–soft combination potential in combination with TPE Medical Two material platforms adhere extremely well to each other Potential for osteoconductivity enhancement without loss of mechanical properties Usually brittleness increases, not so with the DSM Rigid platform

DSM Rigid platform compared to PEEK offers:

Sufficient strength – properties even closer to bone

Higher toughness

Improved processability, better flow @ lower temperatures

Hard–soft combination potential in combination with TPE Medical

Two material platforms adhere extremely well to each other

Potential for osteoconductivity enhancement without loss of mechanical properties

Usually brittleness increases, not so with the DSM Rigid platform

TPE – Rigid : A perfect union TPE and Rigid Platforms use similar chemical backbones  perfectly blendable  perfect adhesion Implant concept for hard/soft material combinations: IP Filed TPE Rigid TPE Can be customized for individual designs

TPE and Rigid Platforms use similar chemical backbones

 perfectly blendable

 perfect adhesion

Implant concept for hard/soft material combinations:

IP Filed

Orthopedic Devices Bridging the gap between tissues Rigid Construction Material 4 Material Segments

Orthopedic Devices Bridging the gap between tissues Elastomeric / Shock Absorption material Wear Resistance / Surface Bearing Material Rigid Construction Material Strong Fiber for Suspension 4 Material Segments

A world class portfolio of Biomedical Materials

Solutions for Medical Implants From the Leader in Biomedical Polymer Solutions

DSM Biomedical A world class Biomedical Portfolio Drug Delivery Resorbable Polymer Platform for local delivery Biomedical Materials Ophthalmic Materials UHMwPE UHMwPE Fibers Polyurethanes TPE Medical Rigid Polymer Solutions Design Support Prototyping Component Fabrication Device Assembly Medical Coatings Lubricious Anti-Microbial Anti-Fouling Bionate ® BioSpan ® CarboSil ® Elasthane ™ PurSil ® Drug Delivery ™

Drug Delivery

Resorbable Polymer Platform for local delivery

Biomedical Materials

Ophthalmic Materials

UHMwPE

UHMwPE Fibers

Polyurethanes

TPE Medical

Rigid Polymer

Solutions

Design Support

Prototyping

Component Fabrication

Device Assembly

Medical Coatings

Lubricious

Anti-Microbial

Anti-Fouling

Contact us P.O. Box 18 6160 MD Geleen The Netherlands +31 46 4760278 [email_address] www.dsmbiomedical.com Disclaimer The description by DSM Biomedical of the characteristics and properties of its products and services as contained in this presentation are supported by research and believed to be reliable. They are for general information purposes only and may not be relied upon in individual situations. All materials offered by DSM Biomedical are supplied under contract containing detailed product specifications, and the user shall be exclusively responsible to assess the suitability and fitness for purpose of the product as specified by the user for any individual application or use . materials that belong to the body