Invibio Innovation Timeline

PEEK-OPTIMA™ is launched
- PEEK-OPTIMA Natural is launched as the world’s first implantable PEEK polymer

Invibio is formed
- Invibio Biomaterial Solutions formed as a wholly owned subsidiary of Victrex plc to focus exclusively on the medical device market

Invibio achieves ISO Compliance
- Invibio achieves ISO 13485 compliance (cGMP) for the manufacture of PEEK-OPTIMA™ polymer

The first PEEK-OPTIMA™ Approval by the SFDA
- The State Food and Drug Administration (SFDA) approves the first implantable medical device manufactured from PEEK-OPTIMA polymer in China

MHLW approves the first Medical Device using PEEK-OPTIMA™
- The first orthopaedic implant in Japan using Invibio PEEK-OPTIMA receives regulatory approval from the Japanese Ministry of Health, Labour and Welfare (MHLW)

Introduction of PEEK-OPTIMA™ for Trauma
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PEEK-OPTIMA Ultra Reinforced polymer introduced for Trauma, an alternative to metal for use in load bearing medical device applications
First ANVISA approval of a PEEK-OPTIMA device
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Brazilian Health Surveillance Agency (ANVISA) approves the first implantable medical device that uses PEEK-OPTIMA polymer
Frost & Sullivan Product Innovation of the Year Award
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Invibio receives prestigious 2005 Product Innovation of the Year Award for polymeric materials in the medical implant market from Frost & Sullivan

New PEEK-OPTIMA™ Image Contrast Product
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Introduction of PEEK-OPTIMA Image Contrast polymer that allows optimal device and healing site visualization with X-ray, CT and MRI imaging modalities
Launch of PEEK-OPTIMA Reinforced
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PEEK-OPTIMA Reinforced compound introduced to offer enhanced strength, wear properties and imaging capability for load bearing applications
Invibio Global Technical Center Opens
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Invibio opens a dedicated Global Technical Center in the UK. The center houses processing facilities, testing laboratories and a Class 10,000 clean room, ensuring contaminate-free manufacturing capabilities for research and development grades as well as prototype materials and application components

Spine Technology Award
- Invibio receives Spine Technology Award in biomaterial category in recognition of its
PEEK-OPTIMA™ Natural polymer
New Tribology PEEK-OPTIMA Grade
- Invibio introduces PEEK-OPTIMA Wear Performance polymer, with properties specifically tailored for articulating and bearing applications against hard counterfaces

Medical Design Excellence Award (MDEA)
- Invibio is honored by MDEA in recognition to being a vital supplier to the winning Cranial LOOP from NEOS Surgery SL
New Manufacturing Facilities Open
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Invibio opens new, dedicated manufacturing facilities to extend production capabilities at its UK Global Technology Center

JUVORA™, Ltd. is formed
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JUVORA, Ltd. is formed, championing the use of non-metal alternatives in dental prosthetics

PEEK-OPTIMA™ devices implanted milestone
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Four million devices made with PEEK-OPTIMA implanted worldwide1

Invibio launches new brand identity
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New corporate and divisional brands are launched by Invibio
1. Data on file at Invibio

Regulatory milestones
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Invibio reaches a regulatory milestone with the number of cleared devices using PEEK-OPTIMA™ polymers, over 500 in the US and more than 80 in China
PEEK-OPTIMA HA Enhanced is launched
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PEEK-OPTIMA HA Enhanced polymer is launched, demonstrating earlier bone ongrowth and greater new bone formation for interbody fusion1

International PEEK Meeting
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Invibio supports the First International Implantable PEEK meeting with almost 50 presentations and posters
1. Study evaluated the in vivo response to PEEK-OPTIMA Natural, PEEK-OPTIMA HA Enhanced and allograft in a cervical spine fusion model in sheep. Data on file at Invibio. This has not been correlated with human clinical experience.

PEEK-OPTIMA™ HA Enhanced Regulatory Milestones
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PEEK-OPTIMA HA Enhanced receives the first US FDA 510(k) clearance for a cervical Interbody Fusion Device and the first CE mark approval for a cervical and lumbar interbody fusion device

PEEK-OPTIMA Ultra Reinforced is introduced
- PEEK-OPTIMA Ultra Reinforced is introduced as a high-performance, polymer –based, trauma device technology for internal fracture fixation
1. This product is not cleared for implantation or distribution.
Spinal Stabilization System launched in China
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Spinal Stabilization System launched in China, made with PEEK-OPTIMA™ semi-rigid spinal rods

PEEK-OPTIMA HA Enhanced adoption momentum continues
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First human implantation of Cervical Interbody Fusion (IBF) device
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First US FDA 510(k) clearance for Lumbar IBF device

Number of PEEK-OPTIMA devices implanted continues to grow
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Five million devices made with PEEK-OPTIMA implanted worldwide1
1. Data on file at Invibio
2. This product is not cleared for implantation or distribution.