inSteps BV

About inSteps BV

Stroke is the second most common cause of death in the EU, affecting over 1.1 million people each year. Mechanical thrombectomy is the standard of care for severe strokes caused by large vessel blockages, yet fewer than 10% of new neurovascular treatments successfully reach the clinical environment. Device development remains slow, expensive, and heavily dependent on animal models with limited predictive accuracy. inSteps changes this. We have built an AI-enabled computer simulation platform specifically for thrombectomy device development. Our platform combines high-fidelity Finite Element Modelling of device-anatomy and device-thrombus interactions with generative AI to produce thousands of synthetic patient anatomies, trained on one of the world's largest stroke patient databases. Importantly, these synthetic populations are controllable, allowing manufacturers to focus on specific subpopulations. This allows device manufacturers to virtually evaluate new designs across clinically realistic patient populations before physical prototyping begins. Our AI-emulation layer brings simulation times from days to minutes, making high-throughput virtual prototyping, clinical trial optimization, and regulatory evidence generation a practical reality. We serve thrombectomy device manufacturers as a B2B partner across the full device lifecycle: from rapid virtual prototyping and design optimization to clinical trial design support and regulatory submissions aligned with FDA and EMA guidance on computational modelling evidence. inSteps is a spin-out from the Amsterdam University Medical Center, founded in 2023 and built on years of academic research. Our team of AI and biomedical engineering experts brings together deep expertise in Finite Element Modeling, generative AI and clinical stroke research. All capabilities are fully in-house.