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Fiber Based Scaffolds for Medical Applications Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Fiber Based Scaffolds for Medical Applications

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

2

Content

The Freudenberg Group

Scaffolene Technology

Customized Solutions

Summary

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

3

The Freudenberg Group: Key Figures

Family company

160 years old

16 Business Groups

34.000 Employees

Operating in 59 countries

5,481 million EUR in 2010

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

4

Content

The Freudenberg Group

Scaffolene Technology

Customized Solutions

Summary

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

5

Scaffolene Technology: Cutting Edge Technology

Aim: Production of bioresorbable 3-D scaffolds for

medical applications

How do we differentiate from existing technologies?

We have developed unique technology due to the gentle

processing of raw materials and biopolymers

We produce at low temperature, without harmful solvents

and polymeric degradation

The result is a reliable procedure fully dedicated to the

production of bioresorbable nonwoven

What is the advantage of the new technology?

The innovative technology enables to convert highly

sensitive or atypical polymers into bioresorbable 3D

scaffolds

This technology allows to incorporate other sensitive

bioactive materials (e.g. peptides, proteins, antibiotics,

growth factors etc.) into the bioresorbable nonwoven

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Scaffolene Technology: Technical Data & Quality

What are the key facts of our technology?

Platform technology: More than 80% of all medical approved

bioresorbable polymers can be spun

Product variety: Customized solutions since product features

can be adapted to desired specification

Finishing processes: Allmost all of the nonwoven standard

finishing technologies can be applied

Industrial production: Reliable proprietary process, computer

controlled, no cross contamination, clean room environment

Customized solutions: Joint product developments according

to specific customer needs

… and relevant quality standards: The production is in

accordance with all the relevant quality standards as DIN EN

ISO 14644, DIN EN ISO 13485 and DIN EN ISO 10993

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Scaffolene Technology: Matrix Polymers and Additives

Which polymers can be transformed:

Natural Polymers: Gelatin, Gelatin /

Collagen, Dextran, Chitosan, Hyaluronic

acid

Synthetic Polymers: PVP, PEG, PEO,

PCL, PLA

… and which additives can be incorporated:

Ion chelators

Proteins like Enzymes or Growth factors

ECM proteins and other metabolic substrates

Antibiotics or other APIs

Dispersed nanoparticles

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Scaffolene Technology: Product features

Which generic features can we provide?

Can be easily adapted to match every

shape (cutting, multilayer)

Bioresorbable

Suturable

… and which variable features?

3D structure of scaffold can be adjusted to

particular need and specification

Adjustable fibre diameters

Fluid absorption (hydrophilic / hydrophobic)

can be modified

Tensile strength can be varied by different

raw materials

Multilayer is possible

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Scaffolene Technology: Unique product features

Resorption of Nonwovens

Adjustable stability (from several hours to months)

Several processes for cross-linking established

Biocompatibility confirmed

Adjustable hydrophilicity and water-up-take

Elastic but tear resistant in wet state

Release of Actives

Incorporation of sensitive actives into the fibers

Wide variety of actives processable

Adjustable and controlled release

0

10

20

30

40

50

60

70

80

90

100

0 50 100 150 200 250 300 350

sam

ple

mas

s /%

time /h

Gelatin (Cross-linking A)

Gelatin (Cross-linking B)

Gelatin (Cross-linking C)

Gelatin (Cross-linking D)

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Content

The Freudenberg Group

Scaffolene Technology

Customized Solutions

Summary

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Customized Solutions for Medical Applications

Biosurgery

Hemostyptica, adhesion prophylaxis, surgical mesh, …

Advanced / Active Woundcare

Wound heailing, soft tissue regeneration, burn wounds, …

Regenerative Medicine

Regenerative tissue matrices, …

Local Drug Delivery

Antibiotics, contraceptives, cytostatics, growth fators, …

AND FURTHERMORE FOR YOUR PRODUCT IDEAS!!

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

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Content

The Freudenberg Group

Scaffolene Technology

Customized Solutions

Summary

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

13

High innovative power

Using unique technology, innovative products can be developed

in line with customers’ specific requirements

with fast realization times

Satisfied users

Physicians’ and users’ wishes for real innovation are met by

using alternative polymers with modified matrix properties, and

the integration of functions in nonwovens and the controlled release of active ingredients

Reliable production

Industrial-scale production processes are used with guaranteed medical quality

under clean-room conditions

in accordance with all relevant QM standards (e.g. ISO 13485)

Proven service

For more than 160 years, the Freudenberg name has stood for

sustainable high-tech solutions at reasonable prices

satisfied B to B customers

Summary

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

Danke für Ihre Aufmerksamkeit!

Dirk Grafahrend, Freudenberg New Technologies KG 6th October, Medevice – Biomaterials Europe

We are looking forward to welcome you at booth number 100!