Novel manufacturing process and material development for an innovative load bearing hydrogel for use in orthopedic implants

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Orthonika, an SME spin-out from Imperial College London, has developed novel load-bearing polymer materials for use in orthopaedic implants and is now planning to transfer manufacturing from the bench into a production environment. These exciting materials have the potential to address key healthcare challenges associated with soft tissue injuries such as the need for a total meniscus replacement (TMR) in the knee.Hydrogels have long been thought of as highly promising materials for soft tissue replacements, potentially opening up new markets for orthopaedic implants. Their adoption, however, has been hampered by poor mechanical properties and low fracture toughness. Orthonika's novel hydrogel has impressive mechanical properties and a fracture toughness that is superior to the standard crosslinked PVA hydrogels currently in use for orthopaedic applications, and even to the articular cartilage itself.The TMR seeks to address a high unmet clinical need - despite the high prevalence of meniscus injury, treatment options are limited and today's standard of care for a severely damaged meniscus is partial or complete removal. Unfortunately, this procedure is known to create additional problems and lack of a meniscus is a major risk factor for osteoarthritis, a chronic and debilitating joint condition associated with abnormal wear of articular cartilage, affecting more than 4 million people in the UK. An estimated 50% of partial meniscectomy patients are diagnosed with osteoarthritis as a result.Orthonika's product replicates the structure and function of the natural meniscus, providing a durable device that can be implanted with minimal invasion and fixed securely to the bone to withstand the rigor of physical activity - an option not currently available to patients with severe meniscus injury. This solution fulfils a clinical care gap between palliative care practices and total knee replacement, restoring knee function and preventing the onset of osteoarthritis.A number of technological challenges will be addressed in scaling-up a complex free radical polymerisation process in an oxygen void environment whilst incorporating a pre-formed anatomically shaped ultra-high molecular weight polyethylene fibre-reinforcement. Orthonika is sub-contracting elements of this work to UK-based Contamac, an experienced and award-winning supplier of polymers for contact and intraocular lenses for over 30 years. Together we will plan and develop a robust manufacturing process and quality management system to establish whether material and implant can meet our rigorous target specifications.If successful in manufacturing our novel hydrogel at scale, we can address other orthopaedic device opportunities.