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FineHeart

FineHeart

Bordeaux, France· Est.
fineheart.fr
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Private Company

Total funding raised: $45M

Overview

FineHeart, founded in 2010, is a French private medtech company pioneering a novel implantable heart pump, the ICOMS Flowmaker®, for patients with advanced heart failure. The company has achieved significant milestones, including securing substantial financing (€83M total, with a €35M Series C first close), being named the lead partner of a major European IPCEI project (Tech4Cure), and receiving regulatory authorization in Slovenia to commence its First-In-Human clinical study. Positioned as a potential European leader in Active Implantable Medical Devices (AIMDs), FineHeart is advancing a potentially disruptive technology through clinical development with strong institutional and European Union support.

CardiovascularHeart Failure

Technology Platform

ICOMS (Intra Cardiac Output Management System) platform for implantable heart pumps designed to augment native cardiac output per cycle.

Funding History

2
Total raised:$45M
Series B$35M
Series A$10M

Opportunities

The large and growing unmet need in advanced heart failure presents a multi-billion dollar market.
Leadership of the EU IPCEI project provides significant non-dilutive funding, strategic positioning, and potential supply chain advantages.
A successful device with a better safety profile could expand treatable patient populations beyond current LVAD candidates.

Risk Factors

High clinical development risk associated with a novel, complex active implantable device.
Stringent and evolving regulatory pathways in the EU (MDR) and US (FDA).
Intense competition from established LVAD manufacturers and other heart failure device innovators.
Execution risk in scaling manufacturing and building a commercial organization.

Competitive Landscape

FineHeart competes in the mechanical circulatory support (MCS) market, dominated by Abbott's HeartMate 3 LVAD. It also faces competition from other miniaturized and less invasive pump technologies in development, as well as from alternative heart failure therapies like cardiac contractility modulation (CCM) devices and baroreceptor activation therapy. Its differentiation hinges on its intra-cardiac design aiming for physiological flow and reduced complication rates.

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