17 Feb Press Release: SimInSitu consortium announcement

Posted at 04:59h in Uncategorized by

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

 

Do you need more info?

If you need more info about SimInSitu, do not hesitate to contact us or write us an email to sales@4realsim.com