UK-based medical device developer Orthox has received a Letter of No Objection from the UK’s MHRA to start its FFLEX (FibroFix cartiLage repair Experience) study.
The study is aimed to evaluate the efficacy and safety of Orthox’s FibroFix Cartilage P (FibroFix) implant and accessory surgical instrumentation in the knee joints of patients with cartilage injuries.
It is funded by the National Institute for Health and Care Research (NIHR), the Wellcome Trust, and the European Innovation Council (EIC) Accelerator.
FibroFix is intended to treat the articular cartilage in the knee, which protects the ends of the femur (thigh bone) and tibia (shin bone).
It keeps the surfaces of these bones safe and makes it possible for the joint to function smoothly.
Orthox co-founder and CEO Nick Skaer 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.”
Patient recruitment is anticipated to begin in July at the primary clinical site, Southmead Hospital, North Bristol NHS Trust, UK, prior to being extended throughout Europe.
The company is also preparing clinical trial locations in Budapest and other major European hospitals, and it has filed a regulatory dossier to OGYÉI, Hungary’s medical device regulatory agency.
Orthox has also started regulatory programmes for FibroFix in the US, China, and Europe.
