FineHeart, founded in 2010 in Pessac near Bordeaux, makes FlowMaker, an implantable pump that sits in the heart, synchronises with its natural contractions and is powered wirelessly. The company says it needs no external driveline, unlike current heart assist devices, and its EIC project said 95% of patients with severe heart failure are "left without any solution", according to CORDIS.

The European Innovation Council granted €2,500,000 towards a €9.9 million project from October 2022 to March 2025, which aimed to "conduct the clinical trials to enter the EU market in 2026, then the US market". The final report says the first implantation in a human was completed, more than 50 clinical-grade devices were made and the technology moved from readiness level 5 to 8. The first implants took place at IKEM in Prague in 2024, according to FineHeart's announcement. In 2025 it won approval for studies in France and Slovenia, and in January 2026 it announced €83 million in funding. It has not yet applied for EU market approval.

€2.50MEIC grant, 25% of a €9.9M project
2024First human implants, Prague
€83MFunding announced, January 2026
2026EU market entry targeted, trials still running

Company file

Legal entity
FineHeart SA, SIREN 519 375 356, Pessac
Founded
2010
CEO and co-founder
Arnaud Mascarell
CSO and co-founder
Stéphane Garrigue
Product
FlowMaker (ICOMS) intracardiac pump
IP
26 patent families, 55 granted patents
EIC project
FLOWMAKER, 1 Oct 2022 to 31 Mar 2025

Where FineHeart Stands Now

France's medicines agency ANSM authorised a multi-centre first-in-human study in June 2025, led by Pascal Leprince at Pitié-Salpêtrière, and Slovenia's JAZMP followed in July. In July 2025 FineHeart was named lead partner of IPCEI Tech4Cure, an Important Project of Common European Interest for implantable medical devices, jointly notified by six member states. The January 2026 funding included a €35 million first closing of a Series C and was described as a key lever for activating IPCEI public funding. At the end of 2024, before this money, FineHeart's equity was negative at minus €5.88 million, according to Pappers.

"This crucial achievement allows us to realize FineHeart's vision."

Arnaud Mascarell, CEO and co-founder, FineHeart, November 2024, on the first implants

The Technology: A Pump Inside the Heart

According to the company, FlowMaker was implanted in Prague on a beating heart, without stopping it, and unlike other devices it needs no bypass to the aorta; its compact size and low energy use allow wireless power. The trial in France is designed to assess safety, implant feasibility and preliminary performance. No patient numbers or outcomes from the first implants have been published.

What the EIC Project Promised, and What CORDIS Shows

The project promised the clinical trials needed to enter the EU market in 2026. It delivered the first human implants, manufacturing of clinical devices and regulatory approvals for multi-centre studies, and FineHeart plans to expand production space from 1,200 to 3,500 square metres. The trials that would support an EU application were only authorised after the project ended, which makes 2026 market entry out of reach on the public record. CORDIS still lists the project as signed.

  1. First-in-human implantsDeliveredPrague, 2024.
  2. Clinical manufacturingDelivered50+ devices.
  3. Multi-centre trialsAuthorisedFrance, Slovenia, 2025.
  4. EU market in 2026Not on trackNo CE application announced.

The Money

FineHeart lost €6.19 million in 2022, €8.21 million in 2023 and €7.65 million in 2024, and its equity fell from €10.7 million to minus €5.88 million over those years. The EIC grant covered a quarter of the project. The 2026 financing changes that picture, but FineHeart has not named its investors or broken down the €83 million.

What Cannot Be Checked

Questions for the EIC

How many patients have received FlowMaker and how they have fared, who invested in the Series C, how much of the €83 million is public money, and whether the EIC Fund invested are not public.

Why Europe Should Care

The EIC project spoke of "EU sovereignty in severe heart failure treatment", and FineHeart now leads a six-country IPCEI for implantable devices. It has taken its pump into patients; whether it works over time is what the trials now starting will show.

What the project promised

Clinical trials to enter the EU market in 2026 with a fully implantable, wireless heart pump.

What the record shows

First implants in Prague, trial approvals in two countries, €83 million announced and no EU approval yet.

The Verdict

In patients, not yet on the market

FineHeart got further than most EIC medtechs: its device is in patients and it has raised serious money. The 2026 market entry it promised the EIC is not supported by any published trial result.

FineHeart and the EIC have not been asked for comment for this article. It is based entirely on public records and published statements, linked throughout.