Periodic Reporting for period 2 - Confident (Confident®, the digital simulation platform that revolutionizes cardiovascular interventions)
Reporting period: 2023-05-01 to 2023-10-31
Despite significant advances, cardiovascular diseases remain the first cause of death.
Mini-invasive interventions such as endovascular aortic repair (EVAR) and transcatheter mitral valve repair (TMVr) are promising but with several strong limitations:
- Lack of quantitative parameters to select treatment strategy.
- Poor technical success rates for some types of procedures.
- Still long interventions with significant radiation dose for patients.
- Suboptimal outcomes often leading to reinterventions.
- High rate of post-operative complications (up to 40%).
- Low-rate eligibility for patients suffuring from cardiovascular diseases
In addition, the time to market for a new device is too long, due to lack of usage of numerical simulations during the design phase and in silico clinical trials during the validation phase.
PrediSurge goal is to solve those problems and, consequently, make cardiovascular interventions safer and more efficient for patients, physicians and manufacturers.
To achieve this goal, PrediSurge aims to create a software (called PlanOp) using digital twin technologies and artificial intelligence, in order to deliver predictive simulations for cardiovascular interventions that will help predicting post-operative complications and developing better devices.
PlanOp patented AI algorithms create 3D digital twins of the patient’s anatomy of interest and of the corresponding implants, with real-life biomechanical behavior.
PlanOp enables:
- Patient-specific digital simulation of the procedure: physicians can visualize in 3D the behavior of the implanted device.
- Virtual testing and selection of different devices and implantation strategies, days before implantation.
- Prediction and prevention of postoperative complications using computation of quantitative and qualitative criteria.
- Better design of future devices
- Un In Silico clinical trials
Mini-invasive interventions such as endovascular aortic repair (EVAR) and transcatheter mitral valve repair (TMVr) are promising but with several strong limitations:
- Lack of quantitative parameters to select treatment strategy.
- Poor technical success rates for some types of procedures.
- Still long interventions with significant radiation dose for patients.
- Suboptimal outcomes often leading to reinterventions.
- High rate of post-operative complications (up to 40%).
- Low-rate eligibility for patients suffuring from cardiovascular diseases
In addition, the time to market for a new device is too long, due to lack of usage of numerical simulations during the design phase and in silico clinical trials during the validation phase.
PrediSurge goal is to solve those problems and, consequently, make cardiovascular interventions safer and more efficient for patients, physicians and manufacturers.
To achieve this goal, PrediSurge aims to create a software (called PlanOp) using digital twin technologies and artificial intelligence, in order to deliver predictive simulations for cardiovascular interventions that will help predicting post-operative complications and developing better devices.
PlanOp patented AI algorithms create 3D digital twins of the patient’s anatomy of interest and of the corresponding implants, with real-life biomechanical behavior.
PlanOp enables:
- Patient-specific digital simulation of the procedure: physicians can visualize in 3D the behavior of the implanted device.
- Virtual testing and selection of different devices and implantation strategies, days before implantation.
- Prediction and prevention of postoperative complications using computation of quantitative and qualitative criteria.
- Better design of future devices
- Un In Silico clinical trials
PlanOp is composed of three key elements: the core technology, the in-house developed features, and the platform to run the complete process:
Core technology:
PrediSurge is a spin-off company from the Center for Biomedical and Healthcare Engineering of Mines Saint-Etienne.
We obtained an exclusive license agreement to use and commercially exploit the patented innovative technology of patient-specific numerical simulation dedicated to endovascular interventions.
We continuously improve this core technology to improve its performance (speed and accuracy) and increase our technology independance.
Performance of PlanOp was demonstrated in more than 150 patients through 3 clinical studies with a 99% spatial accuracy in device positioning.
Features:
- Aortic: we focus on three main features: Sizing (implant selection), Complications (complications prediction) and Consumables (selection of procedure tools).
Sizing: Features are now fully developed and available in production
Complications predictions: Predictive algorithm of the main EVAR complication (endoleak type 1A) is developed (under the name of Endoleak RIsk Index "ERI") and final validation is now completed for Medtronic Endurant and CE mark obtained (October 2023). The corresponding clinical study is EnduSim (1, 2 & 3). EnduSim 1 is completed and scientific publications in progress. Type 1B endoleak in iliac arteries and stent-graft iliac limb stenosis/occlusion algorithms are under development. In parallel, we work with new manufacturers (Terumo and Gore Medical) to adapt ERI to their stent grafts.
Consumables: This functionality are still under developement through two studies: Fendi and Simcath.
- Mitral valve:
The simulation models for mitral valve secondary regurgitation before and after clip implantation are developed. Clinical study is in progress with 20 patients included and 8 patients fully simulated successfully.
As of today two patients have been fully simulated and validated.
- Peripheral: Goal is to extend the aortic feature to peripheral system (iliac, carotid, coronary). This part is under investigation.
Platform:
The new architecture design (AWS, replacing IBM + local machines) is going to be deployed beginning of December allowing us to scale.
Core technology:
PrediSurge is a spin-off company from the Center for Biomedical and Healthcare Engineering of Mines Saint-Etienne.
We obtained an exclusive license agreement to use and commercially exploit the patented innovative technology of patient-specific numerical simulation dedicated to endovascular interventions.
We continuously improve this core technology to improve its performance (speed and accuracy) and increase our technology independance.
Performance of PlanOp was demonstrated in more than 150 patients through 3 clinical studies with a 99% spatial accuracy in device positioning.
Features:
- Aortic: we focus on three main features: Sizing (implant selection), Complications (complications prediction) and Consumables (selection of procedure tools).
Sizing: Features are now fully developed and available in production
Complications predictions: Predictive algorithm of the main EVAR complication (endoleak type 1A) is developed (under the name of Endoleak RIsk Index "ERI") and final validation is now completed for Medtronic Endurant and CE mark obtained (October 2023). The corresponding clinical study is EnduSim (1, 2 & 3). EnduSim 1 is completed and scientific publications in progress. Type 1B endoleak in iliac arteries and stent-graft iliac limb stenosis/occlusion algorithms are under development. In parallel, we work with new manufacturers (Terumo and Gore Medical) to adapt ERI to their stent grafts.
Consumables: This functionality are still under developement through two studies: Fendi and Simcath.
- Mitral valve:
The simulation models for mitral valve secondary regurgitation before and after clip implantation are developed. Clinical study is in progress with 20 patients included and 8 patients fully simulated successfully.
As of today two patients have been fully simulated and validated.
- Peripheral: Goal is to extend the aortic feature to peripheral system (iliac, carotid, coronary). This part is under investigation.
Platform:
The new architecture design (AWS, replacing IBM + local machines) is going to be deployed beginning of December allowing us to scale.
PlanOp is CE marked and our QMS has been successfully audited by TUV SUD.
The first version of PlanOp Aortic sizing is already deployed in 6 countries. It offers a complete simulation service for the design of custom-made devices. +80 users are registered including employees of 3 device manufacturers and more than 80 clinical centers. 300 patients have been treated using our technology.
CE mark and FDA approval is key for ERI deployment. That said, even if ERI is still under validation, Medtronic Europe is really interested and they have decided to launch a pilot phase using retrospective data (23 patients).
ERI si CE marked (Oct. vs target Sept. 23), Partnership with Medtronic Europe is in progress.
In parallel, we need to ensure our IP is protected and a patent for ERI has been filed on the 15th of March at OEB (EP23162028).
The first version of PlanOp Aortic sizing is already deployed in 6 countries. It offers a complete simulation service for the design of custom-made devices. +80 users are registered including employees of 3 device manufacturers and more than 80 clinical centers. 300 patients have been treated using our technology.
CE mark and FDA approval is key for ERI deployment. That said, even if ERI is still under validation, Medtronic Europe is really interested and they have decided to launch a pilot phase using retrospective data (23 patients).
ERI si CE marked (Oct. vs target Sept. 23), Partnership with Medtronic Europe is in progress.
In parallel, we need to ensure our IP is protected and a patent for ERI has been filed on the 15th of March at OEB (EP23162028).