IRIS-VISTA: From Proof-of-Concept to Market Readiness in Predictive Neurovascular Medicine

Objetivo

IRIS-VISTA (Intelligent Rupture-risk Imaging System – Validation & Investor-Ready Simulation Tool for Aneurysms) aims to transform cerebrovascular care by delivering accurate, personalized assessments of rupture risk in unruptured intracranial aneurysms (UIAs). Current clinical practice relies mainly on aneurysm size, leaving many high-risk patients undetected and others unnecessarily treated. IRIS-VISTA addresses this gap by integrating multimodal imaging, computational fluid dynamics (CFD), and explainable artificial intelligence (XAI) within a secure cloud-based platform to provide reliable and clinically interpretable rupture-risk predictions.

Within the EIC Pre-Accelerator, the project will advance the system from TRL 4–5 to TRL 6 through three core objectives: (1) clinical validation using anonymized datasets from partner hospitals to ensure accuracy, reproducibility, and workflow integration; (2) investor readiness through the development of a regulatory roadmap, financial model, and scalable business strategy; and (3) market preparation via engagement with hospitals, insurers, and MedTech stakeholders to refine the value proposition and define early pilot opportunities. These activities directly support the EIC Pre-Accelerator Work Programme by combining technology validation, business acceleration, and early market engagement to prepare a high-potential innovation for scale and investment.

By project completion, IRIS-VISTA will deliver a clinically tested, regulatory-aligned, and investor-ready Minimum Viable Product (MVP). This foundation will enable CE-marking preparation, international expansion, and transition to the EIC Accelerator. The platform advances predictive and precision medicine by improving rupture-risk stratification, reducing unnecessary interventions, and enhancing patient outcomes, while ensuring long-term commercial sustainability and strong societal impact.