Device Design optimization
Explore the performance of novel treatments and optimal device design and with our in-silico platform. We can assess the interaction of thrombi (with various compositions) with different stent designs and settings, in intracranial artery geometries derived from real-life patients. Novel treatments can extensively be evaluated for a large variety of virtual patients and different sub-populations before entering the very expensive (pre-)clinical trials. This allows for identifying the most promising device designs for subsequent animal experiments and pre-clinical trials.
• Thrombectomy design optimization
• Translation to clinical performance
Clinical Trial Design and Patient Selection
Our in-silico platform enables us to execute in-silico trials using extensive exploration of scenarios to better understand what impacts clinical outcome. In-silico trials inform on optimal patient stratification and identification of subpopulations with increased treatment success or alternatively those that are at higher risk of treatment failure or complications. In-silico predictions thus, can be leveraged to optimize clinical trial design. In addition, head-to-head comparisons of different treatment devices can also be performed.
• Clinical Trial Design
• Patient population selection
Regulatory Approval Support
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. In-silico platforms will never replace clinical trials completely, but our in-silico platform provides key 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. In-silico supportive evidence vastly increases probability of regulatory success and speed to market.
• Regulatory Approval