Public Funding for Sirakoss Limited

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SIRAKOSS developed and manufacture a novel calcium phosphate-based bone graft substitute for use in spinal and trauma surgery and the first product was recently CE-marked. This material has shown excellent performance in pre-clinical models of these surgeries but the nature of this material has a disadvantage in that it cannot be processed using high temperatures (\>1000°C) that traditional calcium phosphate materials can be. This means it cannot be sintered to form a macroporous ceramic, so can't utilise 3D printing approaches to manufacture complex/custom implant designs, and it cannot be coated onto medical devices using industry standard approaches. We have identified a process to modify our existing technology to produce a new composition that initial studies have shown is thermally stable at the high temperatures required to manufacture such ceramics and coatings. This project aims to characterise fully this new composition, test its ability to be formed into a macroporous ceramic, and screen these samples in a pre-clinical study to evaluate the bone healing response. This proof of concept would allow SIRAKOSS to be able to develop new products in the future that utilise this new formulation, which could include customised implants utilised 3D printing and bioactive coatings in spinal cages and other orthopaedic medical devices.

The major outcome of this project will be the development by SIRAKOSS Ltd of a bone graft substitute product that will replace the need for surgeons to harvest bone from a patient to act as a graft to repair diseased or damaged bone. Currently surgeons who are repairing fractured bones after traumatic injury, or filling a bone defect after removal of diseased bone, or fusing vertebrae in the spine to alleviate back pain have limited options for obtaining a bone graft to aid effective and fast bone repair in these surgeries. The clinical ‘standard’ has been to harvest bone from the patient’s own body (an autograft) but this needs a second operation, results in significant pain at the harvest site, has a limited supply, and may not be possible in some patients. The reasons that a patient’s own bone is the clinical ‘standard’ is that it offers a unique combination of bone forming properties that supports bone to repair. A number of synthetic materials have been produced as bone graft substitutes but these do not provide the range of bone forming properties that autograft does. INNOVATE UK Biomedical Catalyst funding of 70% of a total project cost of approximately £1,300,000 gives SIRAKOSS the opportunity to develop, approximately 2 years ahead of current timescales, a new synthetic bone graft substitute that combines SIRAKOSS’ patented technology with collagen to form an implant that the surgeon can use straight from a sterile package, offering the properties of autograft but without the disadvantages to the patient that the use of autograft brings.

SIRAKOSS Ltd have developed a novel bone graft substitute (BGS) that will revolutionise the treatment of bone defects and fusions. Developed to offer the surgeon an alternative to having to graft the patient’s own bone, which involves a second surgical procedure associated with graft site pain and increased healthcare costs, the SIRAKOSS synthetic implants are capable of regenerating bone in fractures and bone defects. Bone is the second most commonly transplanted tissue, next to blood, with over 2 million bone graft procedures performed worldwide every year. Biomedical Catalyst funding of £900,000 will allow SIRAKOSS to finalise development of their novel bone graft substitute and complete pre-clinical testing to support regulatory approval for clinical use in Europe.