about US

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^TM 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 JUVORA 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 China¹

PEEK-OPTIMA HA Enhanced is launched

• PEEK-OPTIMA HA Enhanced polymer is launched, demonstrating earlier bone ongrowth and greater new bone formation for interbody fusion²

International PEEK Meeting

• Invibio supports the First International Implantable PEEK meeting with almost 50 presentations and posters

1. Data on file at Invibio
2. 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^TM 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

• Spinal Stabilization System launched in China, made with PEEK-OPTIMA™ semi-rigid spinal rods

PEEK-OPTIMA^TM 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.

Invibio and Maxx Orthopedics collaborate on knee-replacement technology

• Invibio Knee Ltd, a subsidiary of Invibio partners with Maxx Orthopedics, Inc. to develop a PEEK-OPTIMA™ femoral knee¹ replacement

1. PEEK-OPTIMA femoral knee product is in the pre-market phase.

JUVORA™ dental disc receives US FDA 510(k) clearance for long-term implant borne prosthetics

• Using CAD/CAM workflows, the JUVORA implant prosthetic frameworks can be tailor-made to the patients’ specific needs.

PEEK-OPTIMA™ devices implanted milestone

• ~9 million devices made with PEEK-OPTIMA™ implanted worldwide¹

Invibio partners with UK Olympic sprinter, James Ellington, after a severe tibia fracture

• With an Intramedullary Nail made from PEEK-OPTIMA™ Ultra-Reinforced James Ellington is working towards competing professionally again

1. Data on file at Invibio

JUVORA™ CAD/CAM dental disc, with new Oyster White color, launched in US

• Provides dental professionals the choice of working with a whiter and brighter high-performance polymer solution that is FDA 510(k) cleared

PEEK-OPTIMA™ HA Enhanced expanded use in lower extremities

• First foot and ankle implant made from PEEK-OPTIMA™ HA Enhanced receives FDA 510(k) clearance¹

1. Image provided courtesy of Nvision Biomedical Technologies.