Groundbreaking Innovation Receives TGA Approval in Australia

LEATHERHEAD,England,Dec. 3,2024 -- MatOrtho,the UK-based global innovator of hip and knee replacement devices,today announced that the ReCerf® Hip Resurfacing Arthroplasty has become the world's first all-ceramic hip resurfacing system to receive regulatory approval. Approval from the Therapeutic Goods Administration (TGA) in Australia marks a transformative moment for joint replacement technology and patient care.

"This is a monumental achievement not only for MatOrtho but for the field of orthopaedic surgery," said Oriol Millet-Lopez,Interim CEO at MatOrtho. "ReCerf represents the culmination of years of innovation and dedication to improving patient outcomes. TGA approval underscores the system's proven early performance and potential to redefine hip replacement globally."

Exceptional Clinical Outcomes

The ReCerf Hip Resurfacing System has been delivering exceptional outcomes for patients since September 2018. With over 1,200 patients having received the device,fewer have required further operation than usually anticipated with traditional hip replacement and preexisting hip resurfacing devices at this timepoint1. Both male and female patients,many who are relatively young and engage in high-level sports,are returning to their active lives without limitations1. In this year's Annual Report,the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) has reported ReCerf to have a revision rate of just 0.3% (95% confidence intervals 0.0% to 2.1%) at three years2.

A World-First Achievement with Global Implications

TGA approval for ReCerf marks the first regulatory authorisation of its kind globally,setting the stage for further advancements in hip resurfacing technology. MatOrtho continues to work with the Australia Prosthesis List Advisory Committee (PLAC) to have ReCerf included on the next prosthesis list. They are also actively engaged in regulatory approvals in other key markets,to bring the benefits of Ceramic-on-Ceramic Hip Resurfacing with ReCerf to many more patients with the appropriate indications.

Mike Tuke,Founder of MatOrtho (formerly Finsbury),added: "ReCerf's all-ceramic 'delta' composition avoids concerns over metal implants,offering a safe and effective alternative to patients who can maintain more of their native hip and potentially avoid needing a conventional stemmed total hip replacement at all. ReCerf is highly attractive to surgeons specialising in the demanding hip resurfacing operative technique. Both surgeons and patients can pursue this with confidence,knowing it comes from the company recognised as the home of modern hip resurfacing."

Looking Ahead

ReCerf is the result of over a decade of research and development by MatOrtho Ltd.,combining clinical insights with advanced materials. Its approval signifies a turning point in the industry to provide surgeons and their patients a commitment to the very best long-term patient-centred care.

For more information about the ReCerf Hip Resurfacing System and MatOrtho's commitment to orthopaedic innovation,please visit www.recerf.com.

Media Contact:

Name: Dr Michael Watson PhD MCIM

Title: Senior Product Manager

Company: MatOrtho

Contact Tel: 01372 224200

Email:ReCerf@MatOrtho.com

Website: www.MatOrtho.com

About MatOrtho:

MatOrtho is a global leader in orthopaedic innovation,dedicated to advancing hip and knee joint replacement technologies that improve patient outcomes and set new industry benchmarks. With a commitment to clinical excellence and patient care,MatOrtho continues to revolutionise the future of orthopaedic solutions worldwide.

References:

1. MatOrtho Limited. Data on file 01 December 2024.

2. Lewis PL et al. Hip,Knee and Shoulder Arthroplasty: 2024 Annual Report,Australian Orthopaedic Association National Joint Replacement Registry,AOA: Adelaide,South Australia. 2024.