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Associated Press

FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France

BORDEAUX, France--(BUSINESS WIRE)--Jun 3, 2025-- 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 the French National Agency for the Safety of Medicines and Health Products (ANSM) to initiate its First-In-Human (FIH) clinical trial in France. 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. It follows the first successful implantations carried out in 2024 at IKEM ( Institute for Clinical and Experimental Medicine ) in Prague, whose initial results have been presented at several international scientific congresses. Conducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker®. 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. Pr Pascal Leprince, Head of the Thoracic and Cardiovascular Surgery Department at Hôpital Universitaire Pitié-Salpêtrière (AP-HP) Sorbonne Université and principal investigator of the clinical trial in France, commented: " The launch of this trial in France represents a highly promising step forward for patients with advanced heart failure. Thanks to its pulsatile operation, synchronized with the heart's electrical activity, the FlowMaker® could transform the treatment of these patients, offering them a less invasive and potentially more durable solution than current devices. We look forward to starting this clinical study and confirming these benefits.'1ANSM: French National Agency for the Safety of Medicines and Health Products About FineHeart -FineHeart View source version on CONTACT: Europe Media Relations Annie-Florence Loyer [email protected] +33 (6) 88 20 35 59FineHeart Communications James Palmer [email protected] +33 (0) 7 60 92 77 72 KEYWORD: EUROPE CZECH REPUBLIC FRANCE INDUSTRY KEYWORD: MEDICAL DEVICES OTHER HEALTH HEALTH CLINICAL TRIALS CARDIOLOGY SOURCE: FineHeart S.A. Copyright Business Wire 2025. PUB: 06/03/2025 07:01 AM/DISC: 06/03/2025 07:01 AM