Further milestone for JUVORA dental disc: US FDA clears PEEK polymer CAD/CAM dental device for long-term implant borne prosthetics

Thornton Cleveleys (UK), March 22, 2017 - A major innovation in dental prosthetics for comfort, durability and precision, the JUVORA™ dental disc, has received the US Food and Drug Administration 510(k) clearance for expanded indications. Indications for use in the United States now include the manufacture of full and partial removable dentures and implant overdentures, as well as copings, substructures (cemented or uncemented), and frameworks for permanent and transitional anterior or posterior crowns and bridgework. JUVORA implant prosthetic frameworks can be tailor-made to patients´ specific needs, using CAD/CAM workflows, and result in reduced treatment times and better treatment outcomes.

Following its successful CE mark approval in Europe and introduction onto the European dental market in 2012, the JUVORA dental disc received initial FDA 510(k) clearance for purchase and use throughout the US in 2014. With this latest clearance, the FDA has cleared a CAD/CAM device made of PEEK polymer for the manufacture of long-term implant-borne prosthetic frameworks, compatible for use with fixed rehabilitation systems including the ALL-ON-4 treatment concept and, the STRAUMANN3 PRO ARCH system.

This proven alternative to metal prosthetic devices is made from PEEK-OPTIMA™ high performance polymer. The biomaterial with more than 15 years of proven clinical efficacy is sourced exclusively from Juvora´s parent company Invibio Ltd. It offers a superior combination of strength, natural bone-like flex and toughness, with more than five million PEEK-OPTIMA-based devices now implanted worldwide.

Significant improvement for dental prosthetic patients

In addition to receiving endorsements from a growing number of dental labs and dental practitioners, the feedback from patients has been extremely positive. An overwhelming 99% of patients rated JUVORA prosthetics high for comfort and 97% rated them high for overall satisfaction.
'Patients have told us their JUVORA prosthetics feel like having their natural teeth back. This is not to mention a reduction in weight, and superior comfort through tailored fit because the prosthetic has been made with precision through CAD/CAM workflows', noted Lynne Todd, Head of Invibio Dental and Juvora.
What sets the JUVORA dental disc apart are the outstanding properties of PEEK-OPTIMA™ Natural, the world's first implantable PEEK polymer which is widely recognized within the spinal interbody fusion market and frequently used. The unique feature-set of the biomaterial, and accordingly the JUVORA dental disc, includes a bone-like modulus which gives the JUVORA implant prosthetic framework the potential to react in a more natural way to the stresses and forces it encounters.

A new era in the precision design of advanced dental prostheses

'Dentists in the US are now able to offer dental prosthetics that are not only more comfortable than those made from metal, but also more accurately and efficiently designed. JUVORA dental prosthetics can be a compelling alternative to metal for long term fixed as well as removable implant prosthetic applications, such as frameworks and other superstructures - both for the dentist and for their patients,' summarised Todd.

Further information about JUVORA can be obtained online at juvoradental.com and at www.youtube.com/user/JUVORADental
Further information about the medical uses of PEEK polymer can also be obtained online at www.medicalpeek.org

References
1. B. Siewert (2017), PEEK in Dental Prosthetics (PEEK in der zahnärztlichen Prothetik Warum? Wann? Wie?), Podium Presentation, SSO Dental Meeting, 11 February 2017
2. The 'ALL-ON-4' treatment concept is a trademark and property of Nobel Biocare Services AG
3. The 'STRAUMANN' name is a trademark of Straumann Holding AG.
4. Patient feedback from 92 cases July 2013 - March 2015
5. Bone Regeneration Based on Tissue Engineering Conceptions -A 21st Century Perspective Jan Henkel, Maria A. Woodruff, Devakara R. Epari, Roland Steck, VaidaGlatt, Ian C. Dickinson, Peter F. M. Choong, Michael A. Schuetz & Dietmar W. Hutmacher, Bone Research (2013) 1, 216-248

About Juvora
Juvora is an Invibio company that is leading the way with the next generation in dental prosthetics, the JUVORA dental disc. A modern and comfortable solution that can be used as a metal alternative for long-term implant borne, fixed and removable prosthetic frameworks made with precision through CAD/CAM workflows. The JUVORA dental disc is made from PEEK-OPTIMA high performance polymer, sourced exclusively for the dental market by Invibio Biomaterial Solutions, part of Victrex plc, an innovative world leader in high performance PEEK-based polymer solutions.

About Invibio
Invibio Ltd, a Victrex plc company, is a global leader in providing high performance biomaterial solutions to medical device manufacturers. The company provides PEEK-OPTIMA™ polymers, advanced technical research and support and manufacturing of components for spine, trauma and orthopaedic medical segments for the development of long implantable medical devices. Today, Invibio's PEEK-OPTIMA™ polymers are used in more than five million implanted devices worldwide.

JUVORA™, INVIBIO™, PEEK-OPTIMA™, INVIBIO BIOMATERIAL SOLUTIONS™ are trademarks of Victrex plc or its group companies. All rights reserved.

About Victrex
Based in the UK, Victrex is an innovative, leading global provider of high-performance polymer solutions for the aerospace, automotive, electronics, energy and medical industries. Every day, millions of people use products and applications containing our polymers - from smart phones, aircraft and cars all the way to medical devices via oil and gas installations. With over 35 years' experience, we provide cutting-edge technological solutions that shape future performance for our customers and markets, and drive value for our shareholders. Further information is available online at www.victrex.com

VICTREX™, APTIV™, VICOTE™, VICTREX PIPES™, VICTREX HT™, VICTREX ST™, VICTREX WG™, PEEK-ESD™ and the Triangle (Device), are trademarks of Victrex plc or its group companies.

Copyright © 2017 Juvora Ltd, an Invibio Company

Contacts
Invibio Biomaterial Solutions
Nick Tsiakas, JUVORA Marketing Communications Manager
[e-mail], Phone [phone]

Victrex media contact
Beate Sauer, PR & Marketing Communications Manager
[e-mail], Phone +49 61 92 / 96 49 19

Group media or Investor Relations enquiries
Andrew Hanson, Head of Investor Relations & Communications
[e-mail], Phone [phone]