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

• 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

• Brazilian Health Surveillance Agency (ANVISA) approves the first implantable medical device that uses PEEK-OPTIMA polymer  

Frost & Sullivan Product Innovation of the Year Award

• 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

• 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

• PEEK-OPTIMA Reinforced compound introduced to offer enhanced strength, wear properties and imaging capability for load bearing applications

Invibio Global Technical Center Opens

• 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

• Invibio opens new, dedicated manufacturing facilities to extend production capabilities at its UK Global Technology Center

JUVORA™, Ltd. is formed

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

PEEK-OPTIMA™ devices implanted milestone

• Four million devices made with PEEK-OPTIMA implanted worldwide¹

Invibio launches new brand identity

• New corporate and divisional brands are launched by Invibio

1. Data on file at Invibio

Regulatory milestones

• 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

International PEEK Meeting

• 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

• 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.

PEEK-OPTIMA HA Enhanced adoption momentum continues

• First human implantation of Cervical Interbody Fusion (IBF) device

• First US FDA 510(k) clearance for Lumbar IBF device

Number of PEEK-OPTIMA devices implanted continues to grow

• 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.