Over 4 million people annually in the UK are affected by pain and immobility caused by a deficient meniscus in the knee, costing the equivalent of 1% GNP. This includes those suffering from age-related osteoarthritis as well as meniscal damage from accidents or sports injuries. Treatment options have been limited by challenges in developing load-bearing materials with suitable surface characteristics and fixation methods to form an anatomical replacement meniscus. In the absence of replacement devices, the standard of care for an irreparable meniscus (85% of all meniscal tears) is partial or complete removal (meniscectomy), with 2 million/year such procedures worldwide. The consequence is reduced quality of life for patients and a treatment gap for both early-stage irreparable meniscal injury and later stage degenerative disease that often necessitates knee replacement. Orthonika now seeks to leverage a novel deposition processes to augment the TMR peripheral surfaces with porous, polymeric scaffolds optimised for meniscocapsular in-growth, enabling first-of-its-kind strong, physiological fixation over its entirety, mimicking native menisci and maximising clinical performance. The resulting device is intended to emulate successful, established Meniscal Allograft Transplant (MAT) techniques, in a synthetic, off-the-shelf form.

Public description Over 4 million people annually in the UK are affected by pain and immobility caused by a deficient meniscus in the knee, costing the equivalent of 1% GNP. This includes those suffering from age-related osteoarthritis as well as meniscal damage from accidents or sports injuries. Treatment options have been limited by challenges in developing load-bearing materials with suitable surface characteristics and fixation methods to form a replacement meniscus. In the absence of replacement devices, the standard of care for an irreparable meniscus (85% of all meniscal tears) is partial or complete removal (meniscectomy), with 2 million/year such procedures worldwide. The consequence is reduced patient quality of life and a treatment gap for both early-stage irreparable meniscal injury and later stage degenerative disease, that often necessitate knee replacement. In response Orthonika, an SME spin-out from Imperial College London, has developed a medical device for surgical implantation as a total meniscus replacement. Unique materials and a patented design are incorporated into an implant that is fixed directly to the bone via a reliable and established method. Building on previous work, Orthonika must now address technical challenges in translating the pre-clinical ovine model to humans, in preparation for first-in-human clinical studies post-project.

Over 4m people annually in the UK are affected by pain and immobility caused by a deficient meniscus, costing the equivalent of 1% GNP (NHS Business Plan 2017). The problem goes beyond age-related degenerative diseases and includes accidents/sports injuries in patients of any age. Technological challenges in developing load-bearing materials with suitable surface characteristics for such soft-tissue orthopaedic applications restrict options for treatment. In the absence of replacement devices, the standard of care for an irreparable meniscus is partial or complete removal (meniscectomy), with 2million/year such procedures world-wide (Li 2020). In response Orthonika, an SME spin-out from Imperial College London, has developed novel, reinforced load bearing PVA-PEG hydrogel materials for use in meniscus replacement. These unique materials are incorporated into an implant fixed directly to the bone via a reliable and established method. Hydrogels have long been thought of as highly promising materials for soft tissue replacements, potentially opening up new markets for orthopaedic implants. Their adoption has been hampered by poor mechanical properties and low fracture toughness. Laboratory tests have shown that Orthonika's PVA-PEG materials have exceptional mechanical and tribological properties that closely mimic those of natural tissue and are superior to the standard crosslinked PVA hydrogels currently in use for other applications. Building on previous work, Orthonika must now address technical challenges in product development to demonstrate GMP manufacturability for clinical-scale production and subsequent validation in ovine studies, targeting readiness for first-in-human clinical studies post-project. The project enables Orthonika to: * Manufacture at clinical-scale, bridging to development for commercial manufacturing post-clinical validation and * Validate the TMR implant in ovine studies and therefore accelerate translation to human. This represents significant progression towards commercialisation/clinical uptake: * New surgical options for patients (alternatives to meniscectomy/TKR) * Enhanced healthcare capabilities (alignment with key performance indicators such as wait times and patient recovery) * Servicing a £1bn+ global market * Potential adaptation to target other load-bearing orthopaedic applications (cartilage, intervertebral discs).

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.

Orthonika was established to develop an orthopaedic implant for total meniscus replacement in the human knee. This is a demanding biological environment requiring sophisticated coatings. The company has combined an innovative manufacturing process with engineering and clinical input to fabricate a textile-reinforced hydrogel substrate for a synthetic meniscus replacement. Its products are designed to replace injured or worn meniscus - a common problem in an ageing and active population often causing pain, instability and restricted movement in the knee. Replacing the meniscus aims to restore function and delay the onset of osteoarthritis and subsequent surgery. Patients currently undergo menisectomy (removal) rather than replacement, as allografts (transplants) are rarely available. Our replacement product is made from a novel composite material that more accurately mimics the natural structure of meniscal tissue to provide a durable implant that can be implanted and fixed securely; it has the potential to be a first in class product.

Given the critical role the menisci play in the knee joint in terms of load transmission and joint stability, Meniscus injury is the most frequent orthopaedic surgical intervention with meniscus -related operations accounting for up to 50% of all knee surgeries. Despite this prevalence, for severely damaged menisci today’s standard of care is still partial or total meniscectomy with extremely limited treatment options. Removal of the meniscus is a surgical procedure that is now well understood to be a major risk factor for osteoarthritis (OA) a chronic and debilitating condition that effects more than 4 million people in the UK , with an estimated 50% of partial meniscectomy patients being diagnosed with OA as a result. Orthonika, with support through the BMC programme, aim to address this healthcare challenge with the development of the first synthetic total replacement meniscus that accurately mimics the natural structure of meniscal tissue replicating the ‘structure-function’ of the natural meniscus to provide a durable implant that can be implanted with minimal invasion and fixed securely to the bone to withstand the rigour of physical activity - an option not currently available to patients with severe meniscus injury. The solution fulfils a clinical care gap between current palliative care practices and total knee replacement, restoring function and preventing the onset of OA.