FineHeart S.A., a clinical-stage medical technology company specializing in the development of innovative solutions for cardiology, announces that it has received authorization from JAZMP, the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, to begin its First-In-Human (FIH) clinical study.

This prospective, non-randomized study is designed to assess the safety, implant feasibility and preliminary clinical performance of the FlowMaker® device in patients with advanced heart failure.

FlowMaker® is a new-generation, fully implantable left ventricular assist device designed to work in synergy with the heart's natural contraction. Less invasive than current devices, this technology aims to preserve native cardiac function while significantly improving patients' quality of life.

Professor Ivan Kneževič, MD.PhD, cardio surgeon and director of the Transplantation Centre of the University Medical Centre in Ljubljana, will lead the study. "It is a real privilege to take part in this first FIH study. FlowMaker represents a major technological advance in the treatment of patients with advanced heart failure" he said.

Arnaud Mascarell, CEO and co-founder of FineHeart, comments: "Following approvals in the Czech Republic and France, the Slovenian authorization represents another strong endorsement of our preliminary clinical results and our technology by European health authorities. It reflects the growing confidence within the cardiology community in our disruptive approach. This latest green light reinforces our clinical strategy across Europe—a critical step toward securing CE marking. Our goal remains clear: to deliver an innovative, less invasive solution for patients with advanced heart failure, where current treatment options remain limited."

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