Orthox Limited, a clinical stage company developing medical implants to repair damaged knee articular cartilage and other orthopaedic injuries, can start its FFLEX (FibroFix cartilage repair experience) study.
The company has received a Letter of No Objection from the UK’s MHRA, enabling the start of the study.
The study, which is also 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 has received granted patents in the US, China, the UK, Germany, and France derived from key patent application “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 self-anchoring capability of Orthox’s FibroFix Cartilage implant enabling stable implantation and fixation to the underlying bone.
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), said: “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 that 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.
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 more than 1.3 million total knee replacements in the US and EU in 2011.
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 programs for FibroFix in the US, China and Europe. It said the extension of intellectual property coverage into the late 2030s provided by the recent patent grants in these major markets will be essential in providing a solid platform for commercialization.