REG - Victrex PLC - US FDA approval: Total Knee Study

VictrexAnnouncement

17/09/2024 14:00

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RNS Number : 5569E  Victrex PLC  17 September 2024

 

17 September 2024

Victrex plc

US FDA Approval for Total Knee Arthroplasty Study in the US

Victrex plc is an innovative world leader in high performance polymer
solutions, delivering sustainable products which support CO2 reduction and
enable environmental and societal benefit in multiple end-markets.

The Group today announces that, in partnership with Maxx Orthopedics Inc, the
U.S. Food and Drug Administration (FDA) has granted Investigational Device
Exemption (IDE) approval for Freedom® Total Knee System with Invibio
PEEK-OPTIMA™ Femoral Component, as a staged study. The study, projected to
be 120 patients at clinical sites in the US, will compare using the
PEEK-OPTIMA™ Femoral Knee Component to a controlled registry of the same
system using traditional metal femoral components.

 

The US study will build on the existing clinical trial for PEEK Knee at sites
in Belgium, India and Italy, which has been progressing strongly since the
first implant in 2021, with no clinical intervention. A regulatory submission
in India is also expected imminently, supporting the potential for a
commercial PEEK Knee in the market in 2025.

 

Jakob Sigurdsson, Chief Executive of Victrex, said: "PEEK Knee has the
potential to be a game-changer for total knee replacement. Being able to
further assess its benefits through rigorous clinical evaluation in the US
will build on the strong progress so far through clinical trial sites in
Europe and India. We look forward to the study's progression and remain
optimistic about the transformative impact this pioneering device could have
on the future of joint replacement.

 

"In relation to the regulatory submission in India, following a tenacious
focus on innovation, development and investment to scale this significant
opportunity, we now look forward to the potential for a PEEK Knee being in the
market during 2025 and commercial revenues. We also continue to see growing
interest in PEEK Knee from across the medical device industry, beyond our
existing collaborations."

 

Victrex plc:

 Andrew Hanson, Director of Investor Relations, Corporate Communications &      +44 (0) 7809 595831
 ESG
 Jakob Sigurdsson, Chief Executive                                              +44 (0) 1253 897700
 Ian Melling, Chief Financial Officer                                           +44 (0) 1253 897700

 

About Victrex:

Victrex is an innovative world leader in high performance polymer solutions,
focused on the strategic markets of Automotive, Aerospace, Energy &
Industrial, Electronics and Medical. Every day, millions of people rely on
products or applications which contain our sustainable materials, from
smartphones, aeroplanes and cars to oil & gas operations and medical
devices. With over 40 years' experience, we are moving beyond the polymer into
semi-finished and finished products which shape future performance for our
customers and our markets, enable environmental and societal benefit for our
customers and drive value for our shareholders. Find out more at
www.victrexplc.com (http://www.victrexplc.com)

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