Since the start of the project, we have made progress in developing new technologies for bone regeneration. We have successfully shifted the production of our specialized cells (aMSCs) and our advanced bone graft materials from research setting to a professional manufacturing process that meets industry standards. This change is important for making our technologies more accessible to larger groups of patients. We have also conducted economic assessments to understand the potential market for these new clinical therapies. Early testing in animals has shown promising results, and we are working with an external organization to conduct safety tests that meet regulatory standards. These efforts will help us prepare important documents needed for clinical trials. Recently, we've been focusing on how our advanced therapy products are released, stored, and validated. We have looked to use PRP as an alternate to fibronectin and BMP-2 with Healiost; this has produced some mixed data compared to use of BMP-2. In vivo data seem to suggest that bone regeneration is more closely associated with BMP-2 presence, indicating that FN may be a more effective delivery method. We have established a reliable manufacturing process and received regulatory approval for clinical use, and we have completed a long-term stability study for our graft materials. Initial studies in animals suggest that our coatings are effective, and we are addressing some challenges related to the use of PRP. Overall, these insights will help us guide future research and improve the real-world applications of our innovations in bone regeneration.
We have hosted three Translation Days for invited clinicians to share progress on the project to date, gain feedback and build relationships for future research development and clinical trials. As a result of these sessions, in principle, we have identified a group of sufficient clinician interest across Europe to run a multi-centre trial of non-union repair in the future. As a consortium, we have highlighted and presented results of the project to date at local, national, and international conferences aimed at relevant scientific, clinical and other industrial stakeholders. We have also participated in public engagement events with demonstrations and activities to exhibit our HEALIKICK technologies to the wider public. Results produced from the project have also been shared in open access, peer reviewed journal publications.
