{"id":61363,"date":"2025-06-03T13:03:33","date_gmt":"2025-06-03T11:03:33","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/"},"modified":"2025-06-03T13:03:33","modified_gmt":"2025-06-03T11:03:33","slug":"fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/","title":{"rendered":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France"},"content":{"rendered":"
\n

\nPatients with advanced heart failure will be treated with FlowMaker\u00ae, an innovative, fully implantable device for restoring cardiac output.<\/i><\/b><\/p>\n

BORDEAUX, France–(BUSINESS WIRE)–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 <\/i>(FIH) clinical trial in France.<\/p>\n

<\/a>
<\/a><\/p>\n

\nThis prospective, non-randomized study is designed to assess the safety, implant feasibility and preliminary clinical performance of the FlowMaker\u00ae 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<\/i>) in Prague, whose initial results have been presented at several international scientific congresses.<\/p>\n

\nConducted in several French centers specializing in cardiac surgery, this study represents a decisive step in the clinical development of FlowMaker\u00ae.<\/p>\n

\nFlowMaker\u00ae 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.<\/p>\n

\nPr Pascal Leprince<\/b>, Head of the Thoracic and Cardiovascular Surgery Department at H\u00f4pital Universitaire Piti\u00e9-Salp\u00eatri\u00e8re (AP-HP) Sorbonne Universit\u00e9 and principal investigator of the clinical trial in France, <\/b>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\u00ae 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<\/i>.”<\/p>\n

\n“ANSM approval marks a key strategic step for FineHeart. It validates the quality and solidity of our preclinical work and confirms the relevance of our initial clinical results. This green light paves the way for the acceleration of our clinical roadmap, with the ambition of responding to a major unmet medical need. It also sends a strong signal to the entire MedTech ecosystem, and to all our partners and investors, whom we thank for their confidence<\/i>” says Arnaud Mascarell, CEO and co-founder of FineHeart.<\/b><\/p>\n

\n1 <\/sup><\/i>ANSM: F<\/i>rench National Agency for the Safety of Medicines and Health Products<\/i><\/b><\/p>\n

\nAbout FineHeart – <\/b>FineHeart<\/a><\/p>\n

Contacts<\/b> <\/p>\n

\nEurope<\/b>
Media Relations
\n
Annie-Florence Loyer
\n
afloyer@newcap.fr<\/a>
+33 (6) 88 20 35 59<\/p>\n

\nFineHeart Communications<\/b>
James Palmer
\n
j.palmer@orpheonfinance.com<\/a>
+33 (0) 7 60 92 77 72<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

Patients with advanced heart failure will be treated with FlowMaker\u00ae, an innovative, fully implantable device for restoring cardiac output. BORDEAUX, France–(BUSINESS WIRE)–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 … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-61363","6":"format-standard","7":"category-industry"},"yoast_head":"\nFineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Patients with advanced heart failure will be treated with FlowMaker\u00ae, an innovative, fully implantable device for restoring cardiac output. BORDEAUX, France–(BUSINESS WIRE)–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 ... [Read more...]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/\" \/>\n<meta property=\"og:site_name\" content=\"Pharma Trend\" \/>\n<meta property=\"article:published_time\" content=\"2025-06-03T11:03:33+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg\" \/>\n<meta name=\"author\" content=\"Business Wire\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Business Wire\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/\"},\"author\":{\"name\":\"Business Wire\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\"},\"headline\":\"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France\",\"datePublished\":\"2025-06-03T11:03:33+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/\"},\"wordCount\":414,\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250603183502\\\/en\\\/2487160\\\/22\\\/Logo_FineHeart_D%C3%A9f.jpg\",\"articleSection\":[\"Industry\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/\",\"name\":\"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250603183502\\\/en\\\/2487160\\\/22\\\/Logo_FineHeart_D%C3%A9f.jpg\",\"datePublished\":\"2025-06-03T11:03:33+00:00\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#primaryimage\",\"url\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250603183502\\\/en\\\/2487160\\\/22\\\/Logo_FineHeart_D%C3%A9f.jpg\",\"contentUrl\":\"https:\\\/\\\/mms.businesswire.com\\\/media\\\/20250603183502\\\/en\\\/2487160\\\/22\\\/Logo_FineHeart_D%C3%A9f.jpg\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Startseite\",\"item\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#website\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"name\":\"Pharma Trend\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#organization\",\"name\":\"Pharma Trend\",\"url\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"\",\"contentUrl\":\"\",\"caption\":\"Pharma Trend\"},\"image\":{\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/logo\\\/image\\\/\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/pharma-trend.com\\\/en\\\/#\\\/schema\\\/person\\\/02d41342c7a74fa7f0032bb35ef0bb24\",\"name\":\"Business Wire\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/","og_locale":"en_US","og_type":"article","og_title":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend","og_description":"Patients with advanced heart failure will be treated with FlowMaker\u00ae, an innovative, fully implantable device for restoring cardiac output. BORDEAUX, France–(BUSINESS WIRE)–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 ... [Read more...]","og_url":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/","og_site_name":"Pharma Trend","article_published_time":"2025-06-03T11:03:33+00:00","og_image":[{"url":"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg","type":"","width":"","height":""}],"author":"Business Wire","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Business Wire","Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#article","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/"},"author":{"name":"Business Wire","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24"},"headline":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France","datePublished":"2025-06-03T11:03:33+00:00","mainEntityOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/"},"wordCount":414,"publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg","articleSection":["Industry"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/","url":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/","name":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France - Pharma Trend","isPartOf":{"@id":"https:\/\/pharma-trend.com\/en\/#website"},"primaryImageOfPage":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#primaryimage"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#primaryimage"},"thumbnailUrl":"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg","datePublished":"2025-06-03T11:03:33+00:00","breadcrumb":{"@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#primaryimage","url":"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg","contentUrl":"https:\/\/mms.businesswire.com\/media\/20250603183502\/en\/2487160\/22\/Logo_FineHeart_D%C3%A9f.jpg"},{"@type":"BreadcrumbList","@id":"https:\/\/pharma-trend.com\/en\/fineheart-receives-ansm1-authorization-to-deploy-its-first-in-human-clinical-study-in-france\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Startseite","item":"https:\/\/pharma-trend.com\/en\/"},{"@type":"ListItem","position":2,"name":"FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France"}]},{"@type":"WebSite","@id":"https:\/\/pharma-trend.com\/en\/#website","url":"https:\/\/pharma-trend.com\/en\/","name":"Pharma Trend","description":"","publisher":{"@id":"https:\/\/pharma-trend.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/pharma-trend.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/pharma-trend.com\/en\/#organization","name":"Pharma Trend","url":"https:\/\/pharma-trend.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/","url":"","contentUrl":"","caption":"Pharma Trend"},"image":{"@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/logo\/image\/"}},{"@type":"Person","@id":"https:\/\/pharma-trend.com\/en\/#\/schema\/person\/02d41342c7a74fa7f0032bb35ef0bb24","name":"Business Wire"}]}},"_links":{"self":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/61363","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/comments?post=61363"}],"version-history":[{"count":0,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/posts\/61363\/revisions"}],"wp:attachment":[{"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/media?parent=61363"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/categories?post=61363"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/pharma-trend.com\/en\/wp-json\/wp\/v2\/tags?post=61363"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}