EMBARC: Engineered Microarchitectures for Bone Augmentation and Repair through Cellular Control

We are developing a novel 3D-printed bone graft substitute for restorative dentistry. It exploits the ability of cells in our body to feel and respond to the shape of their environment, interpreting it as instructions for how to behave, accelerating new, stable bone formation. By using cutting-edge additive manufacturing (AM) technologies capable of producing these shapes with exceptional precision, this research represents a new approach to healthcare material design for treating bone injuries using regenerative medicine. Bone is the second most transplanted tissue after blood, with over two million procedures performed globally each year. With changing demographics and an increase in population, this number is increasing, driving the need for improved synthetic substitutes as alternatives to autografts and allografts. Whilst our technology has the potential to be applied to a range of orthopaedic indications, we have decided to initially focus on dentistry based on feedback from clinicians on the clinical and market need. This market is also relatively low volume per treatment and would allow us to develop our manufacturing and quality control processes before expanding into other clinical areas. Bone grafting is a common procedure in dentistry, especially when there is insufficient natural bone to support an implant. Typically, synthetic or animal-derived substitutes are used due to practical barriers to using auto/allograft in a dental setting. It is essential that primary stability is achieved in the grafted area before inserting the implant, a period which often lasts for up to a year as the new bone slowly forms. This extended period with missing teeth causes patients both physical discomfort due to difficulties with chewing and speech, as well as emotional distress through increased self-consciousness and reduced self-esteem. Moreover, despite the extended wait period, up to 70% of dental implant failures occur in grafted regions due to low-density or poor-quality bone, leading to revisions and further suffering. This is a result of current synthetic bone grafts often lacking the biological cues needed to actively guide cell behaviour, resulting in poor integration and slow healing, contributing to the higher risk of implant failure and confirming the need for improved alternatives. We have already demonstrated that a particular design we discovered, DesignX, actively and innately promotes cell and tissue infiltration and supports bone-like tissue deposition in the laboratory. In a subcutaneous implant model, we have demonstrated that this is conserved, promoting tissue integration and vascularisation. Using the latest 3D printing technologies, we can fabricate this new type of material within commercially viable timeframes. We now face a single, critical, high-risk aim: demonstrating that when implanted into a real bone defect, these materials are effective at supporting bone formation. Our project objectives are to assess this by implanting our new synthetic graft material into a real bone defect and quantifying new bone formation through 3D Imaging (microCT scanning) and histology. Only by bridging this gap in this proposal will we be provided with the data needed to attract the funding and industry partners needed to translate this product to clinical use.