Platform validation in an expanded dataset with temporary studies (120 patients and 36 controls). The purpose of the research is to validate the robustness of the measures presented in the preclinical exploratory phase, where high correlations between fractal dimension and the pathological state were shown, having the possibility to use the biomarker of fractal dimension as a support tool for:
In-depth study of tools and licenses compatibles with a platform that provides the user enough information to classify its patients through the analytical results of our product.
Having the purpose of knowing the limits of our technology, a comprehensive scientific analysis of all the possible scenarios will be conducted, where an international multicentric database is needed. It will be necessary to validate the platform in sufficiently broad and variable groups of patients—acquisition protocol, scanner used, resolution and image quality, severity of the disease, etc.—, as well as representatives of the disease.
Once the development and validation are finished, we will proceed to legally regulate our platform as a medical product in order to obtain the European Conformity certificate (CE), as well as the American certificate of Food and Drug Administration (FDA).