ACCELERATING STROKE TREATMENT INNOVATION THROUGH AN AI-ENABLED IN-SILICO NEW APPROACH METHODOLOGY (NAM)

Información del proyecto

InSteps

Identificador del acuerdo de subvención: 101328131

DOI

10.3030/101328131

Fecha de la firma de la CE 3 Julio 2026

Fecha de inicio 1 Septiembre 2026

Fecha de finalización 31 Mayo 2027

Financiado con arreglo a

• The European Innovation Council (EIC)

Coste total

Sin datos

Aportación de la UE

€ 300 000,00

Coordinado por

INSTEPS BV
Netherlands

Objetivo

Stroke remains the primary cause of adult disability and the second leading cause of death in the European Union, imposing a global economic burden of over €890 billion. The current design and development of thrombectomy devices is primarily driven by trial-and-error methodologies utilizing models with suboptimal translational capability to the actual clinical environment. Traditional preclinical validation relies on animal models and oversimplified bench tests that fail to predict human outcomes. 90% of neurovascular treatments that show promise in preclinical stages fail to achieve their primary endpoints in human clinical trials. Moreover, developing medical devices is an inefficient process, costing up to €100 million per device and development cycles lasting up to eight years.
inSteps B.V. addresses this crisis through the world’s first high-fidelity In-Silico Thrombectomy Digital Twin Platform. By merging state-of-the-art Finite Element Method (FEM) simulations with Generative AI, the platform creates a revolutionary virtual trial environment powered by a unique database of 4,500 real-world patients. This allows for the synthesis of diverse virtual cohorts to simulate the intricate mechanical interactions between medical devices, vascular anatomy, and human-derived clots with unprecedented precision. By providing a fail-fast mechanism, this data-driven approach allows developers to rapidly iterate and discard suboptimal prototypes before significant capital is committed. This ensures only the most promising technologies advance and de-risks clinical trials, increasing the probability of success and a streamlined path to regulatory approval.
This paradigm shift transforms the R&D landscape, slashing design iteration cycles from six weeks to just five days and reducing development expenditures from €5 million to less than €500,000 per project. inSteps directly supports the EU Biotech Act and the EMA’s 3Rs strategy to replace, reduce, and refine animal testing.

Ámbito científico (EuroSciVoc)

• ciencias naturales › informática y ciencias de la información › base de datos

Palabras clave

• In-silico Thrombectomy Digital Twin Finite Element Method Virtual Patient Cohort Ischemic Stroke Vascular Anatomy Modeling Thrombus-Device Interaction Generative AI Neural Network Synthetic Data

Programa(s)

• HORIZON.3.1 - The European Innovation Council (EIC) PROGRAMA PRINCIPAL
  
• HORIZON.3.1.3 - Additional EIC activities
  

Tema(s)

• HORIZON-EIC-2026-AIC-02 - Translating Disruptive New Approach Methodologies (NAMs) into Practice
  

Régimen de financiación

HORIZON-EIC - HORIZON EIC Grants

Convocatoria de propuestas

HORIZON-EIC-2026-AIC

Coordinador

INSTEPS BV

• Aportación neta de la UEn: € 300 000,00
• Dirección: ROETERSSTRAAT 35 ; 1018WB Amsterdam ; Países Bajos
• Pyme Sí:
  Tipo de actividad
  Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Tipo de actividad: Private for-profit entities (excluding Higher or Secondary Education Establishments)
• Coste total: Sin datos