Periodic Reporting for period 1 - PRIOBONE (A 3D-printable biomimetic bone regeneration material)
Période du rapport: 2024-01-01 au 2025-06-30
Accidents, degenerative diseases or tumour treatments can lead to bone defects. If these defects reach a critical size, they do not heal spontaneously during the patient's lifetime and cause substantial individual, societal and economic burden. Current treatment options are hampered by associated complications, poor functional or aesthetic outcomes, a limited availability of tissue for bone grafts, and high financial costs. Worldwide, more than 4 million surgeries per year require bone grafts or substitute materials. Consequently, there is a significant clinical and economic need for novel treatments for critical-size bone defects. For this purpose, the project PRIOBONE has brought forward a new material with a composition that mimics natural bone. It is well tolerated by cells, promotes bone growth, possesses excellent mechanical properties and is 3D-printable. Therefore, the material has the potential to surpass conventional treatments and alternative solutions on the market. In this way, the new material could enable the production of implants that are optimized for patient needs. This includes, for example, the ability to print the material in a foldable form so that it can be inserted minimally invasively into defect sites, where it then unfolds again. Furthermore, the use of established components and our approach, which is based exclusively on non-living materials, are expected to enable a faster track to clinical application and regulatory approval than developments that contain biological components such as cells or previously unknown components.
In the project PRIOBONE, this new material was validated for bone regeneration and commercialization avenues were explored. We expect that PRIOBONE will provide a cost-efficient, individualizable alternative to current treatments with the potential to significantly lower the economic, individual and social burden of critical-size bone defects.
In the project PRIOBONE, this new material was validated for bone regeneration and commercialization avenues were explored. We expect that PRIOBONE will provide a cost-efficient, individualizable alternative to current treatments with the potential to significantly lower the economic, individual and social burden of critical-size bone defects.
To bring the PRIOBONE material closer to clinical application and commercialization, we validated its potential for bone regeneration, resulting in a material toolbox with 3D printable bone-mimetic materials with well-defined properties that meet the needs formulated by clinicians from orthopedics, trauma surgery and dentistry. Our research activities included a comprehensive biological and physico-chemical characterization of the material, and optimization of the material to different delivery pathways (e.g. open surgery versus minimally invasive surgery). Furthermore, technical aspects important for clinical translation and commercialization were studied. The material was adapted to required standards and the scalability of the production process was analyzed. This led to the presentation of several product types based on the developed and optimized material. A comprehensive market analysis, IP research and interactions with companies and clinical partners yielded the development of a strategy for further sustainable progress of the project.
The new material allows extrusion 3D printing of bone-mimetic nanocomposite hydrogels in porous designs with unprecedented shape-fidelity. Its potential for bone regeneration - and consequently for improving the treatment of critical size bone defects - were underlined by experimental validation and an in-depth market analysis.. The results of the material development led to a patent application and a publication in the journal Biofabrication (doi: 10.1088/1758-5090/adbb90). However, further research is required to translate the PRIOBONE material into a medical product suitable for routine clinical use.