Aortic aneurysms can be repaired by placing a stent graft inside the artery, a procedure called EVAR; PrediSurge's risk tool targets type 1A endoleaks, leaks at the top of the graft. PrediSurge, a 2017 spin-off of the engineering school Mines Saint-Étienne, builds patient-specific digital twins of the aorta from CT scans and simulates how a chosen graft will sit, so surgeons can pick a size and model before operating.
The European Innovation Council granted €2,500,000 towards Confident, a €9.09 million project that ran from November 2022 to October 2024. According to the CORDIS report, its Endoleak Risk Index received CE marking in October 2023, the technology was used for 300 patients, and it had more than 80 users across 6 countries. In November 2023 PrediSurge closed a €6.5 million Series A led by the Italian fund LIFTT, with the European Investment Bank and the European Commission among the investors. US approval, the report's next step, has not been announced.
Company file
- Legal entity
- PrediSurge, SIREN 829 714 203, Saint-Étienne
- Founded
- 3 May 2017, spin-off of Mines Saint-Étienne
- Products
- iSizing, Endoleak Risk Index, FEVAR simulation, Virtual Lab
- Certification
- CE Class IIa medical software; ISO 13485 and 27001
- Industry partners
- Medtronic, Terumo, Stryker, GE HealthCare, per company
- Investors
- LIFTT, EIB, European Commission, Saint Victor Capital, UI Investissement, Crédit Agricole LHL Capital Innovation
- EIC project
- Confident, 1 Nov 2022 to 31 Oct 2024, closed
Where PrediSurge Stands Today
PrediSurge's website now claims more than 2,300 patients simulated, more than 390 clinical centres, 14 patents and 30 scientific publications, and lists Medtronic, Terumo, Stryker and GE HealthCare as partners. It sells automated aortic sizing (iSizing), the Endoleak Risk Index and simulations for fenestrated grafts, and a Virtual Lab for device makers. The French register records a capital increase in August 2026, from €45,721 to €76,611, the first since the Series A; no new round has been announced.
The Technology: Simulating the Graft Before the Operation
The software builds a mechanical model of the patient's aorta and of the chosen graft and simulates the deployment. The CORDIS report claims "99% spatial accuracy in device positioning" across more than 150 patients in three clinical studies. The Endoleak Risk Index, validated for Medtronic's Endurant graft, estimates the risk of a type 1A leak for different graft sizes; adaptation for Terumo and Gore grafts began during the project. A mitral valve model was also in a 20-patient clinical study, with 2 cases validated by project end.
What the EIC Project Promised, and What CORDIS Shows
Confident promised "the digital simulation platform that revolutionizes cardiovascular interventions". The report shows a CE-marked aortic product, a quality system audited by TÜV SÜD, a patent filing for the risk index, and a planned pilot with Medtronic Europe on retrospective data from 23 patients. The mitral valve work was still early, and FDA approval was listed as future work.
- CE-marked aortic toolsDeliveredERI marked October 2023.
- Clinical useDelivered300 patients by 2024.
- Mitral valve simulationEarly2 of 20 cases validated.
- US approvalNot announcedListed as next step.
What Has Happened Since the Award
A study published in PubMed Central reported early clinical experience with the Endoleak Risk Index in planning aortic repairs, supporting its use for individual decisions and training. PrediSurge had raised a first round of €1.5 million in 2020, before the Series A.
The Money
PrediSurge keeps its revenue confidential. The net results recorded by Pappers were losses of €2.53 million in 2023, €0.74 million in 2024 and €1.98 million in 2025, with staff in the 20 to 49 band. The EIC grant covered 28% of the project; the company paid the rest, about €6.6 million.
What cannot be checked
PrediSurge's revenue, how many centres pay for the software rather than use free tools, how much the EU invested in the Series A, and what the 2026 capital increase raised are not public.
Why Europe Should Care
Simulation-based planning is a field where a small French company works with the world's largest device makers. The EIC paid for part of a project that put a certified product on the market in Europe; the company has not announced US approval for its risk tool.
What the project promised
A digital simulation platform that revolutionises cardiovascular interventions.
What the record shows
CE-marked aortic tools, 300 patients by 2024 and 390 centres claimed in 2026, a €6.5M Series A, no FDA approval announced and revenue kept private.
The Verdict
Certified in Europe, still proving itself
Confident delivered a CE-marked product in clinical use and helped PrediSurge raise money from EU and private investors. Revenue, US approval and the mitral valve work, which would show whether this is a business and not only a tool, are not yet in the public record.
PrediSurge has not been asked for comment for this article. It is based entirely on company statements, French company data, scientific literature and EU project data, linked throughout.
