Unmet medical need in Stroke
Stroke is the major cause of death and disability in Europe, causing half a million deaths annually. Despite the recent introduction of increasingly effective treatments, up to two-thirds of patients end up being functionally dependent.
The research, development, and evaluation of new stroke treatments is currently moving at an extremely high pace. Research into better treatment is focused on the development and improvement of thrombectomy devices. The global neuro-thrombectomy market was estimated at €500 million in 2020 and is expected to grow to €900 million by 2028.
Clinical trials are the gold standard for evaluating these new stroke treatments. However, less than 10% of these treatments, evaluated in costly and lengthy clinical trials, have a successful introduction in clinical practice.
Optimizing your thrombectomy device ,trial designs, patient selection and regulatory success
Regulatory tailwind for in-silico methods
The FDA and EMA are expecting that 1 of the 7 clinical trials will be replaced with an in-silico trial solution for regulatory approval of novel devices. Our in-silico platform provides supportive regulatory evidence through what-if scenarios, risk assessments (e.g. vessel perforation risk, clot fracture) and confirmation of stent performance in infrequent events or lesser studied subpopulations.
Unique Clinical Data in Stroke Patients
Our portfolio includes four modules based on real world data of 100s of stroke patients. Our in-silico models have been validated with in-vitro experiments and clinical data. These models are built based upon research funded by the European Union’ s Horizon 2020 program (grant no. 777072), along with the INSIST consortium (www.insist-h2020.eu).
Unique Clinical Trial data on Acute Ischemic Stroke & Thrombectomy
Prof. Henk Marquering, Amsterdam UMC
In-Silico Stroke Treatment Platform
InSteps provides a unique in-silico platform that allows the computer simulation of stroke and its treatment. InSteps allows to test various stent designs in various patient anatomies and clot types before entering into the very expensive clinical trials. With these in-silico models, novel treatments can extensively be evaluated and better implemented for different sub-populations.
Optimizing your thrombectomy device,trial designs, patient selection and regulatory success
A virtual patient is sampled from probability density functions of clinical and imaging characteristics observed in large patient cohorts and interrelationships between them.
Perfusion changes and corresponding infarct for a virtual stroke patient.
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
A finite element model of thrombectomy procedure simulating stent positioning, deployment, and retrieval of the clot
The platform generates virtual patients, simulates their treatment and tissue injury and predicts their clinical outcome of stroke treatment (thrombectomy) at population level.