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[B] PrediSurge — Bruno Virieux (pharma_medtech_exec) [GYJ]

Feature #1253: [B] PrediSurge — Bruno Virieux (pharma_medtech_exec) [GYJ]

Added by Redmine Admin about 1 month ago. Updated about 1 month ago.

Status:
Design
Priority:
Normal
Assignee:
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Start date:
06/25/2026
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% Done:

0%

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Description

**Source:** GetYourJob (classified health-software, actively hiring developers)
**Founder:** Bruno Virieux — CEO (since December 2022). Founders: Jean-Noel Albertini (co-founder & CMO, vascular surgeon), David Perrin (co-founder & CTO), Stephane Avril, Alban Molle
**Background:** pharma_medtech_exec | verified: False — PrediSurge's founders are academic/clinical researchers, NOT pharma/medtech executives. The company is a 2017 spin-off of Mines Saint-Etienne (IMT). Founders: (1) Jean-Noel Albertini, co-founder & CMO/Chief Medical Officer, is a vascular surgeon and international key opinion leader on aortic endovascular repair, whose academic research initiated the company; (2) David Perrin, co-founder & CTO, is an engineer who defended his PhD in 2015 on patient-specific simulation of aortic endovascular repair; (3) Stephane Avril, co-founder, is a Full Professor of soft-tissue biomechanics at Mines Saint-Etienne / IMT (academic, not an executive); (4) Alban Molle, co-founder (limited public background). Separately, the CEO since December 2022, Bruno Virieux, is the only figure who fits a 'medtech exec' description: a graduate of Ecole Centrale de Lyon with 20+ years in the medical-technology sector. He is NOT a founder, and his background is medtech/machine-learning, not pharma. So the 'pharma_medtech_exec' label is wrong for the founders (surgeon + engineers + professor), and even for the CEO 'pharma' is inaccurate (medtech, not pharma).
**Stage / fundraise:** Series A, ~28 employees, founded 2017, commercializing CE-marked products (iSizing launched 2025) / Closed a EUR 6.5M Series A in 2023 (EUR 4M equity), led by Liftt with EIC Fund, Saint Victor Capital, UI Investissement - Metropoles Innovations, and Credit Agricole LHL Capital Innovation; preceded by a EUR 1.5M round in 2020 and a EUR 2.5M EIC Accelerator grant (announced April 2023).
**Regulatory trigger:** Class IIa Software as a Medical Device under EU MDR. PlanOp Aortic V2 and PlanOp/iSizing V1 are Class IIa, CE-marked (notified body 0123). Company holds an EU MDR Quality Management System certificate (2023) and ISO 27001. Class IIa SaMD requires notified-body conformity assessment, IEC 62304 lifecycle, and full technical documentation - exactly the regime OmDev's compliance pipeline (SOUP register + requirements-to-code-to-test traceability) supports.
**Email:** (confidence medium) — Not a published personal address. The published generic address is . RocketReach reports the company email pattern as (used by 100% of sampled addresses), so is a pattern-based inference, not a confirmed published email.
**LinkedIn:** https://www.linkedin.com/company/predisurge/ (company page; CEO personal profile not verified) **Website:** https://www.predisurge.com
**Score:** 8 -> Tier B
**Hook:** PrediSurge is a well-funded (EUR 6.5M Series A) Class IIa SaMD scale-up that is hiring developers while industrializing PlanOp and pushing into new cardiac/structural segments. OmDev's senior team + dedicated CTO + built-in compliance engine (SOUP register signed each build, full requirements-to-code-to-test traceability for the IEC 62304/MDR file) lets them add regulated-software capacity at a fixed monthly price ~3x cheaper than expanding the in-house team - turning each developer hire into a managed pod that feeds their existing QA/RA function instead of a slow, costly headcount ramp.

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## Founder & background
CEO Bruno Virieux (since Dec 2022) is a Machine Learning specialist with 20+ years in medical technology - a pharma/medtech exec profile, not finance/insurance ([about-us](https://www.predisurge.com/about-us/)). The company is a Mines Saint-Etienne spin-off founded in 2017 by a clinical/academic team: vascular surgeon & KOL Jean-Noel Albertini (CMO), engineer-PhD David Perrin (CTO), Stephane Avril and Alban Molle ([Mines Saint-Etienne](https://www.mines-stetienne.fr/en/actualites/predisurge-at-the-forefront-of-medical-technologies-for-endovascular-surgery)).
No finance/insurance founder found - this is an academic-deeptech rather than a non-technical-founder profile, which slightly weakens the ICP fit.

## Funding & momentum
Closed a EUR 6.5M Series A in 2023 (EUR 4M equity), led by Liftt with the EIC Fund, Saint Victor Capital, UI Investissement and Credit Agricole LHL Capital Innovation ([Journal des Entreprises](https://www.lejournaldesentreprises.com/auvergne-rhone-alpes/breve/predisurge-leve-65-millions-deuros-pour-developper-son-jumeau-numerique-cardiovasculaire-2072285); [UI Investissement](https://fr.linkedin.com/posts/ui-investissement_predisurge-achieves-65-million-in-series-activity-7122571315286269952-RxVd)).
Earlier: EUR 1.5M (2020) plus a EUR 2.5M EIC Accelerator grant ([Usine Nouvelle](https://www.usinenouvelle.com/article/communique-loire-un-financement-de-2-5-millions-d-euros-de-la-commission-europeenne-pour-l-entreprise-predisurge.N2212852)). ~28 employees - a funded scale-up, not a pre-seed garage.

## Product & regulatory
Patient-specific digital-twin / predictive simulation for vascular, endovascular and structural-heart surgery ([tech.eu](https://tech.eu/2024/02/06/meet-the-french-company-pioneering-digital-twins-for-cardiovascular-procedures/)). Product line: PlanOp Virtual Lab, iSizing (automated CE-marked EVAR sizing, 2025), MPR View & Share, Endoleak Risk Index.
Regulatory: Class IIa SaMD under EU MDR; PlanOp Aortic V2 / iSizing are CE-marked (NB 0123), with an EU MDR QMS certificate (2023) and ISO 27001 ([PlanOp x Medtech](https://www.predisurge.com/planop-x-medtech/); [about-us](https://www.predisurge.com/about-us/)). Class IIa demands IEC 62304 lifecycle + notified-body assessment.

## Pain & buying signals
They are actively hiring developers (GetYourJob health/software + dev-hiring signal; Tech roles on [Welcome to the Jungle](https://www.welcometothejungle.com/en/companies/predisurge/jobs)). Caveat: they already run a real in-house team - CTO David Perrin, Head of R&D Florian Cotte (PhD), Head of Production, and a dedicated QA & Regulatory Affairs Manager since 2019 ([about-us](https://www.predisurge.com/about-us/)). So the gap is dev-throughput on a regulated multi-product roadmap (industrializing PlanOp, expanding into cardiac/structural), not an absent team. No evidence of agency dependence or an imminent audit deadline.

**Why OmDev fits:** A funded Class IIa SaMD company scaling its regulated codebase is OmDev's sweet spot for capacity. A managed senior pod + dedicated CTO at a fixed price ~3x cheaper than in-house headcount lets PrediSurge accelerate the PlanOp/cardiac roadmap, and OmDev's compliance engine (SOUP register signed each build + requirements-to-code-to-test traceability) plugs directly into their existing QA/RA function and MDR/IEC 62304 file. Tier B (not A): mature in-house dev + QARA and a tech/medtech-exec (not finance/insurance) founder lower ICP fit, while strong funding and a clear regulated-build need keep it a worthwhile target.

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**Sources:** https://www.predisurge.com/about-us/ · https://tech.eu/2024/02/06/meet-the-french-company-pioneering-digital-twins-for-cardiovascular-procedures/ · https://www.lejournaldesentreprises.com/auvergne-rhone-alpes/breve/predisurge-leve-65-millions-deuros-pour-developper-son-jumeau-numerique-cardiovasculaire-2072285 · https://fr.linkedin.com/posts/ui-investissement_predisurge-achieves-65-million-in-series-activity-7122571315286269952-RxVd · https://www.usinenouvelle.com/article/communique-loire-un-financement-de-2-5-millions-d-euros-de-la-commission-europeenne-pour-l-entreprise-predisurge.N2212852 · https://www.predisurge.com/planop-x-medtech/ · https://www.welcometothejungle.com/en/companies/predisurge/jobs · https://www.mines-stetienne.fr/en/actualites/predisurge-at-the-forefront-of-medical-technologies-for-endovascular-surgery · https://rocketreach.co/predisurge-email-format_b40a11f3ffae2489 · https://www.linkedin.com/company/predisurge/

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