Press Release: SimInSitu consortium announcement

4RealSim is honoured and excited to work together with University of Palermo, Katholieke Universiteit Leuven, Ecole des Mines de Saint-Étienne, Xeltis, Capvidia, Leartiker, Graz University of Technology, and ISMETT in a newly formed European Consortium – SimInSitu – after receiving a grant from the EU for the H2020-SC1-DTH-06-2020 call (grant No 101017523).

Advanced Computer Modelling & Simulation technologies have the potential to accelerate the development- and clinical evaluation process of medical devices and to reduce time & cost to market if adequate credibility and reliability can be demonstrated.

SimInSitu is aiming to develop the first in-silico Development & Clinical Trial Platform capable to predict the short- and long-term response of in-situ tissue engineered heart valves (TEHV) in humans. This will enable the virtual clinical evaluation and optimization of the performance and safety of TEHV by a multidisciplinary approach combining advanced patient-specific computational models, tissue & growth remodelling algorithms, and dedicated device models.

SimInSitu will also assess and document the platform’s credibility and reliability by following a hierarchical development and validation approach within a design-control-like environment. Extensive model verifications, validation, and uncertainty propagation evaluations at various complexity levels will make use of a multitude of bench test-, in-vitro- and in-vivo-data to generate the necessary evidence.

SimInSitu will engage with regulators, international initiatives, industry leaders, and other consortia to contribute to the further development of a needed in-silico regulatory framework.
Thanks to the consortium’s complementary and experience and the expertise of its external advisors, the SimInSitu project can leverage on a comprehensive cross-technological, biomedical, clinical, and regulatory knowledge.

SimInSitu consortium members


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