inSteps

The InSteps Stroke Platform offers groundbreaking in-silico solutions for stroke treatment. Our unique technology accelerates the development of thrombectomy devices and optimizes clinical trials, giving more patients access to life-saving treatments.

Unmet Medical Need in Stroke

Stroke remains a leading cause of death and disability in Europe, accounting for half a million deaths annually. Despite the introduction of increasingly effective treatments, up to two-thirds of stroke patients remain functionally dependent, underscoring the urgent need for faster and more effective therapeutic options.

Advances in Stroke Treatment Development

The research, development, and evaluation of new stroke treatments are progressing at an unprecedented pace. A key focus lies in the development and optimization of thrombectomy devices, which are designed to improve patient outcomes. The global neuro-thrombectomy market was valued at €500 million in 2020 and is expected to reach €900 million by 2028, reflecting the increasing demand for more advanced solutions.

Clinical Trials and the Future of In-Silico Methods

Clinical trials remain the gold standard for evaluating the efficacy of new stroke treatments. However, fewer than 10% of treatments tested through costly and lengthy trials achieve successful introduction into clinical practice. To address this, regulatory bodies such as the FDA and EMA anticipate that one in seven clinical trials will be supplemented or replaced by in-silico trial solutions.

Regulatory Support for In-Silico Platforms

Our in-silico platform offers key regulatory support by providing robust evidence through simulations such as "what-if" scenarios, risk assessments (e.g., vessel perforation risk, clot fracture), and confirmation of stent performance in rare or under-researched subpopulations. These tools significantly increase the likelihood of regulatory approval and speed up the time to market for novel devices.

Unique Clinical Data for Stroke Patients

Our platform includes four comprehensive modules based on real-world data from hundreds of stroke patients. These in-silico models have been rigorously validated through both in-vitro experiments and clinical data, with support from research funded by the European Union’s Horizon 2020 program (grant no. 777072) and the INSIST consortium.

The In-Silico Stroke Treatment Platform

InSteps offers a cutting-edge in-silico platform that enables the computer simulation of stroke and its treatment. This platform allows for extensive testing of various stent designs across different patient anatomies and clot compositions, all before proceeding to costly clinical trials. With these simulations, novel treatments can be thoroughly evaluated and tailored for diverse patient subpopulations, optimizing their implementation and effectiveness.

Learn more about the unique predictive capabilities of the in-silico stroke platform

The in-silico Platform for Acute Ischemic Stroke and thrombectomy treatments was developed in a consortium of premier Academic institues and is extensively validated and peer-reviewed. It represent a gold standard uniquely offered by InSteps for commercial application in device development and regulatory approval

Module 1
Virtual stroke population

A virtual patient is sampled from probability density functions of clinical and imaging characteristics observed in large patient cohorts and interrelationships between them.

Module 2
Finite element model

A finite element model of thrombectomy procedure simulating stent positioning, deployment, and retrieval of the clot

Module 3
Stroke disease model

Perfusion changes and corresponding infarct for a virtual stroke patient.

Module 4
In-silico trial platform

The platform generates virtual patients, simulates their treatment and tissue injury and predicts their clinical outcome of stroke treatment (thrombectomy) at population level.