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Orthox 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 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.
Further, Orthox received granted patents in the US, China, the UK, Germany and France derived from key patent application number WO/2018/224800, 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.
FibroFix targets injuries to the articular cartilage in the knee which covers the ends of the femur and tibia. 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 and/or microfracture.
The Company has also submitted a regulatory dossier to the Hungarian medical device regulatory authority 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 and 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.
CEO Nick Skaer said, “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.”
Source: Orthox
Orthox 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 will assess the safety and performance of Orthox's FibroFix™ Cartilage P (FibroFix™) implant and accessory surgical instrumentation in the knee joints of...
Orthox 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 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.
Further, Orthox received granted patents in the US, China, the UK, Germany and France derived from key patent application number WO/2018/224800, 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.
FibroFix targets injuries to the articular cartilage in the knee which covers the ends of the femur and tibia. 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 and/or microfracture.
The Company has also submitted a regulatory dossier to the Hungarian medical device regulatory authority 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 and 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.
CEO Nick Skaer said, “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.”
Source: Orthox
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
