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FibroFix™ Cartilage, silk-based implant for cartilage repair and regeneration, introducing a new paradigm in osteoarthritis treatment.

Periodic Reporting for period 1 - FibroFix Cartilage (FibroFix™ Cartilage, silk-based implant for cartilage repair and regeneration, introducing a new paradigm in osteoarthritis treatment.)

Reporting period: 2020-07-01 to 2021-06-30

Cartilage deterioration and injuries often lead to osteoarthritis (OA) – a long-term chronic disease resulting in bones rubbing together and creating pain, stiffness and severe disability. Knee cartilage injuries are very common and almost half of them go on to develop OA, which is second only to heart disease as a cause of work disability. OA affects over 500million people globally (up to 10% of the global population).

Keyhole surgery to treat knee injury is the most common orthopaedic procedure. The majority involve removing damaged cartilage from either the shock absorbing meniscus or from the smooth, stiff articular cartilage that covers the ends of the thigh and shin bones. While initially relieving pain and restoring mobility, this can accelerate deterioration of the knee joint and frequently leads to the patient developing OA.

Orthox has developed and plans to bring to market FibroFixTM – an innovative implant developed to treat debilitating knee cartilage injuries including damage to the articular cartilage in the knee, degeneration and OA.

The objective of the project is to clinically validate FibroFixTM through pivotal clinical trials, build manufacturing capability, and post-project, commercialise the innovation.
During the first reporting period, Orthox has completed the preclinical verification, validation testing and has nearly completed preparation of the documentation for clinical submission. The company has also made considerable progress on the production scale up, validation and regulatory certification achieving compliance with ISO13485 manufacturing standard and GMP production.
To prevent total knee replacement, many patients who suffer injury to the meniscus or knee cartilage are advised to limit their activity or risk deterioration of the joint. Orthox offers an alternative: strong, resilient, natural implants capable of restoring knee function while allowing the body’s own cells to grow through, and integrate with, the device.

FibroFixTM technology has the capacity to functionally replace articular and meniscal cartilage, while supporting tissue regeneration. This is achieved without needing expensive cells or biologics. It is expected that this solution will allow patients to swiftly return to a fully active, pain-free lifestyle.
FibroFix™ Cartilage