WP1: A new personalised response detection to the biomaterials methodology using Mimotope Variance Analysis (MVA) has been developed and validated with clinical samples from peri-implantitis and diabetic ulcer. A patent is in preparation for the technology.
WP2: 3 immunocompetent on chip organ models were developed using patient macrophages and established under perfusion conditions. Monitoring of the barrier tissue integrity has been achieved by dedicated impedance sensors developed in WP4.
WP3: The process and microfluidic architecture of a fully automated cytotoxicity test was developed, together with microscope and deep learning based image analysis for real time detection of toxicity. An imaging based microfluidic genotoxicity test architecture was developed and is currently considered for patenting.
WP4: A multiparametric electrochemical sensor system was developed, validated and tested under cytotoxicity testing conditions (WP3), with a patent application submitted. An impedance sensor system allowing microscopy imaging was developed and deployed for barrier tissue models (WP2), as well as an automated ELISA on a chip system for the detection of cytokines from organ models and cytotoxicity tests (WP3, WP4) which led to another patent submission.
WP5: An antimicrobial hydrogel which can combat up to 8 consecutive infections was developed as a testing bed for the above technologies, and a patent submitted. A new methodology for mechanical testing of coatings was developed together with in-depth biomechanical characterisation of 3D printed and conventionally produced medical grade materials (silicone and titanium).
WP6: More than 10 different in silico models have been developed for different aspects of biomaterial related risks including microbiota, corrosion, epithelial layer formation/disruption, immune response, toxic effects of degradation products, migration of immune cells etc. These models have also been deployed as web-tools.
WP7: An integrated device, both functional and usability prototype, has been manufactured and demonstrated. The technology integration routes and further expansion possibilities of the instrument from the design perspective were established.
WP8: Oral microbiota analyses were done with patient samples with and without peri-implantitis. Samples were collected from patients with dental implants and diabetic ulcers, for a comprehensive analysis of the reaction to biomaterials at antibody, cell and local tissue level.
WP9: A horizon scanning tool for the early detection of biomaterial related risks (PANBioRA Risk Radar) was developed, validated and deployed. Multicriteria decision making methodologies were used to develop and deploy PANBioRA risk rating system for quantitative comparison and ranking of biomaterials with the techniques developed from WP1-6.
As part of the transversal activities, a value chain analysis and business case definition and exploitation routes were explored. The regulatory and policy framework of the PANBioRA technologies was studied, leading to a set of policy recommendations.
The project was highly successful in terms of dissemination and communication activities, exceeding its set targets. Partners published 44 academic peer reviewed articles in scientific papers, 30 conference proceedings, 3 books and 1 PhD thesis, attended 73 conferences and published 63 non-scientific and non-peer reviewed articles.
