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.
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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.”