Services

Device design optimization

Explore the performance of novel treatments and optimize device design with our in-silico platform. We assess how thrombi with different compositions interact with various stent designs in intracranial artery geometries derived from real-life patients. This allows for a thorough evaluation of treatments across a wide range of virtual patients and subpopulations before entering expensive (pre-)clinical trials. By doing so, we identify 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 allows for the execution of in-silico trials, exploring numerous scenarios to better understand the factors impacting clinical outcomes. These trials guide optimal patient stratification, helping identify subpopulations with higher chances of treatment success, or alternatively, those at greater risk of failure or complications. In-silico predictions can be leveraged to optimize clinical trial designs. Additionally, 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 expect that one in seven clinical trials will be replaced by in-silico trials for regulatory approval of novel devices. While in-silico platforms will never completely replace clinical trials, our platform offers key supportive regulatory evidence through what-if scenarios, risk assessments (e.g., vessel perforation, clot fracture), and confirmation of stent performance in rare events or lesser-studied subpopulations. This evidence significantly increases the chances of regulatory success and accelerates time to market.

• Regulatory approval
• Risk/benefit assessments