ADDITIVE MANUFACTURING PROJECT CLUSTER MEETING > Fundació CIM C/Llorens i Artigas, 12 Parc Tecnològic de Barcelona Barcelona, Spain 2 May 2016 Project HydroZONES Jürgen Groll, coordinator

> > The 2 major objectives of the consortium HydroZONES are: 1.To develop a hierarchically structured hydrogel based mechanically stable scaffold that recapitulates the zonal distribution of the native articular cartilage. 2.To develop and validate a predictive in vitro test system for future evaluation of products for cartilage regeneration in order to reduce the amount of necessary animal experiments in the future. biochemically layered hydrogel 20 layers pure hydrogel construct

Exploitable results (ERs) > ER 1 A bioreactor platform has been developed that will be used to offer services to clients that want to test (osteo)chondral therapies/devices/treatments. ER2 Complete management system for the quality and for regulatory affairs of the development and of manufacturing of tissue engineering devices / ATMPs in the European Union. ER3 3 hydrogel systems suited for dispense plotting were developed

> > > A bioreactor platform has been developed that will be used to offer services to clients that want to test (osteo)chondral therapies/devices/treatments. > Biomaterial companies, orthopaedic companies, medical device companies and academic research institutes > The platform can be used to evaluate and screen treatment/therapies prior to in vivo testing. Ideally, this will reduce the number of animal studies needed and will therefore reduce costs. Furthermore, more quantitative data can be obtained compared to in vivo animal testing, which creates more information about the effect of the tested product/treatment. Finally, it will reduce the time-to-marked of the tested material/device/treatment.

> > Technological Readiness Level > 7 Milestones in the TRL progression up to TRL9 End 2016: TRL 8 End 2017: TRL 9 Main technical challenges in this result Accurate high-resolution force and displacement measurements in order to quantify stiffness of implant materials and neo-tissue. Time to market (Mth/yr): 12/2016

> > IPRs Have you protected or will you protect this result before disclosing it? How? When? Under discussion with our exploitation manager Clayton Wilson. The brand will be registered, but part of the technology may be protected

> > > Complete management system for the quality and for regulatory affairs of the development and of manufacturing of tissue engineering devices / ATMPs in the European Union. > Developers and manufacturers of tissue engineering devices / ATMPs in the European Union. > Safeguarding of resources (finances and time) and optimum time of translation and of time to market by early and structured implementation of quality needs and regulatory requirements.

> > Technological Readiness Level > Ready for adaptation to individual needs of the organisation and for rapid installation, including training and evaluation of effectiveness. Milestones in the TRL progression up to TRL9 TRL8: Installation of the systems in an active company and certification of the QM- System by a Notified Body for Medical Devices of the European Union. Main technical challenges in this result Creation of a Regulatory Affairs Management System and design of its interfaces with a complete quality management system according to EN ISO (including the requirements of the Medical Device Directive 93/42/EEC) for the efficient development and manufacturing of tissue engineering devices / ATMPs in the European Union. Time to market (Mth/yr): TRL9 will be reached in November 2016, when first surveillance audit of the QM system will take place.

> > IPRs Have you protected or will you protect this result before disclosing it? How? When? No protection is planned besides general claim of copy rights.

> > > 3 hydrogel systems suited for dispense plotting were developed > Research institutions Biomedical companies > 3D plotting of biochemically tunable hydrogels with cells embedded

> > Technological Readiness Level > TLR 3/4 Milestones in the TRL progression up to TRL9 not defined Main technical challenges in this result in-vivo validation of printed cell loaded constructs Time to market (Mth/yr): unknown IPRs - Have you protected or will you protect this result before disclosing it? How? When? protection under consideration but unprobable

Expressions of Interest > generally: 3D printable cytocompatible materials, printing hard- and software xcl-table: RAPIDOS: Biomaterial suitable for AM ToMAX: High-throughput AMT system FDMFINISH: Fused Deposition Modeling techniques