Orthox Announces MHRA Authorisation for Clinical Trial of Knee Cartilage Repair FibroFix™ Product Platform

Key patent on implantable tissue repair devices granted in major economies

OXFORD, England, July 13, 2022 /PRNewswire/ -- Orthox Limited, a clinical stage company developing medical implants to repair damaged knee articular cartilage and other orthopaedic injuries, announces it has received a Letter of No Objection from the UK's MHRA, enabling the start of the company's "FFLEX Study" (derived from the "FibroFix™ cartiLage repair Experience"). This study, supported by funding from the National Institute for Health and Care Research (NIHR), Wellcome Trust and the European Innovation Council (EIC) Accelerator, will assess the safety and performance of Orthox's FibroFix™ Cartilage P (FibroFix™) implant and accessory surgical instrumentation in the knee joints of patients suffering with cartilage injuries. Patient recruitment is expected to open in July at the lead clinical site, Southmead Hospital, North Bristol NHS Trust, UK before eventually being expanded across Europe.

The company also announces that it has received granted patents in the US, China, the UK, Germany, and France derived from key patent application number WO/2018/224800 ⁽¹⁾ titled "Implantable Tissue Repair Devices And Methods For Manufacturing The Same". The patent family, which also includes an Australian patent granted in 2021, offers protection for the unique self-anchoring capability of Orthox's FibroFix™ Cartilage implant enabling stable implantation and fixation to the underlying bone.

Commenting on the approval, and patent grant, Nick Skaer, co-founder, and CEO of Orthox said: "This MHRA approval is another significant milestone for our award winning FibroFix product platform. FibroFix is unique in emulating the functional properties of cartilage while also, in laboratory tests, facilitating rapid tissue regeneration. It could make a real difference to patients suffering the debilitating effects of serious knee cartilage injuries. With our approach there is significant bone sparing and strong tissue integration of the implant, which will result in much faster patient recovery from surgery. The multiple grants of our patent in key global economic territories further validates the novelty of our technology and extends our intellectual property coverage across countries in which a significant number of patients could be treated with our FibroFix implants every year."

The Study Chief Investigator, Michael Whitehouse, Professor of Trauma & Orthopaedics at the University of Bristol and NIHR Bristol Biomedical Research Centre (Bristol BRC), commented: "This technology represents the culmination of a huge amount of development of the implant and the associated instruments to allow a reliable and reproducible operation. It potentially fills a gap in current available treatments. It would allow the treatment of immediate pain and limited function for patients with focal cartilage problems. Typically, operations for these problems are technique dependent or require prolonged periods of limited weightbearing or restricted activity. The instruments developed for this implant and the implant itself provide very strong fixation during the course of the operation and allow an early return to normal activity. Successful treatment of focal cartilage lesions may help to reduce the risk of more widespread joint damage in the future."

FibroFix™ is targeted at treating injuries to the articular cartilage in the knee which covers the ends of the femur (thigh bone) and tibia (shin bone). It protects the surface of these bones and allows the joint to operate smoothly. Around 900,000 patients a year in the US suffer from traumatic, often sports-related, injuries to articular cartilage in the knee ⁽²⁾. These injuries are inadequately served by current procedures, typically debridement (trimming away the damaged tissue), and/or microfracture (punching holes in the subchondral bone, to allow bleeding and formation of scar and fibrous tissue). Knee cartilage damage can lead to osteoarthritis, which resulted in over 1.3 million total knee replacements in the US and EU in 2011 ^{(3) (4)}.

The Company has also submitted a regulatory dossier to the Hungarian medical device regulatory authority, OGYÉI, and is planning clinical trials sites in Budapest and additional leading European Hospitals. Orthox has also initiated regulatory programmes for FibroFix™ in the US, China and Europe and the extension of intellectual property coverage into the late 2030's provided by the recent patent grants in these major markets will be essential in providing a solid platform for commercialisation.

References:

(1) - WO2018/224800
https://worldwide.espacenet.com/patent/search/family/059349792/publication/WO2018224800A1?q=WO2018%2F224800

(2) - Cartilage Defects: Incidence, Diagnosis, and Natural History. Oper. Tech. Sports Med. 26, 156–161 (2018):
https://www.sciencedirect.com/science/article/abs/pii/S106018721830042X?via%3Dihub

(3) - International Orthopaedics (SICOT) (2011) 35:1783–1789 Kurtz et al.:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224613/

(4) - Agency for Healthcare Research and Quality, in the U.S., over 754,000 knee replacements were performed in 2017: 
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3224613/

Media contacts:

Orthox
Nick Skaer, PhD.
CEO, Orthox Ltd.
n.skaer@orthox.co.uk

Scius Communications (for international media)
Katja Stout
katja@sciuscommunications.com

About Orthox

Orthox is a clinical stage company developing medical devices to repair damaged cartilage and other orthopaedic injuries. Orthox's FibroFix™ technology, originating from Oxford University, is a revolutionary tissue scaffold based on fibroin, a tissue regenerative protein extracted from silk fibres. FibroFix™ implants remove only the damaged tissue, employing bone-sparing, minimally invasive surgical techniques which enable rapid patient rehabilitation. By combining superb strength and low friction with tissue regeneration FibroFix™ offers the potential for better long-term outcomes, nurturing the body's innate capacity to heal itself. FibroFix™ products have the potential to address an annual market in the knee joint alone estimated at over $2 billion.

The company was spun out of Oxford University and is led by experienced medtech entrepreneurs. The company has raised over £21m, including awards from leading biomedical funding programmes including Wellcome (£2.65m in Translation Awards), the NIHR i4i Programme (£1.9m in Late-Stage Product Development Awards), the UK's Innovation Agency (a £1.7m Biomedical Catalyst Fund Award) and Horizon 2020's EIC Accelerator (a €2.5m grant). Orthox employs 20 people at its site in Oxfordshire.

See our website here: http://www.orthox.com/

About the National Institute for Health and Care Research

The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
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NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

About NIHR Bristol Biomedical Research Centre

NIHR Bristol Biomedical Research Centre's (BRC) innovative biomedical research takes science from the laboratory bench or computer and develops it into new drugs, treatments or health advice. Its world-leading scientists work on many aspects of health, from the role played by individual genes and proteins to analysing large collections of data on hundreds of thousands of people. Bristol BRC is unique among the NIHR's 20 BRCs across England, thanks to its expertise in ground-breaking population health research.

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Wellcome supports science to solve the urgent health challenges facing everyone. It supports discovery research into life, health and wellbeing, and is taking on three worldwide health challenges: mental health, global heating and infectious diseases.