FineHeart Receives ANSM1 Authorization to Deploy Its First-In-Human Clinical Study in France
Patients with advanced heart failure will be treated with FlowMaker®, an innovative, fully implantable device for restoring cardiac output.
BORDEAUX, France, June 03, 2025--(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 (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."
"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" says Arnaud Mascarell, CEO and co-founder of FineHeart.
1 ANSM: French National Agency for the Safety of Medicines and Health Products
About FineHeart - FineHeart
View source version on businesswire.com: https://www.businesswire.com/news/home/20250603183502/en/
Contacts
Europe Media RelationsAnnie-Florence Loyerafloyer@newcap.fr +33 (6) 88 20 35 59
FineHeart Communications James Palmerj.palmer@orpheonfinance.com +33 (0) 7 60 92 77 72
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
CNN
11 minutes ago
- CNN
See moment Trump criticized Musk in Oval Office
See moment Trump criticized Musk in Oval Office President Trump said he was 'very disappointed' with Elon Musk, as the tech billionaire and former adviser continues to blast Trump's massive tax and spending cuts package. The bill is estimated to add $2.4 trillion to the deficit over the next decade. Musk responded on X in real-time saying that he never saw the bill before it passed and said the elimination of America's electric vehicle tax incentives has nothing to do with his opposition to Trump's bill. 01:15 - Source: CNN Vertical Politics of the Day 16 videos See moment Trump criticized Musk in Oval Office President Trump said he was 'very disappointed' with Elon Musk, as the tech billionaire and former adviser continues to blast Trump's massive tax and spending cuts package. The bill is estimated to add $2.4 trillion to the deficit over the next decade. Musk responded on X in real-time saying that he never saw the bill before it passed and said the elimination of America's electric vehicle tax incentives has nothing to do with his opposition to Trump's bill. 01:15 - Source: CNN Curtis Yarvin is inspiring a new generation of MAGA CNN's Hadas Gold interviews anti-democracy author Curtis Yarvin about his argument for an all-powerful executive in the White House. 02:24 - Source: CNN DNC Trolls Trump with Taco Truck The Democratic National Committee parked a taco truck outside the RNC headquarters in Washington DC Tuesday, as a way to troll the president over an acronym created by a Financial Times commentator about the president's frequent walk backs and pauses to his tariff's. 00:52 - Source: CNN Musk calls Trump's bill 'disgusting abomination' Elon Musk lashed out at President Donald Trump's agenda bill — which the president is pressuring GOP senators to support — calling it a 'disgusting abomination.' CNN's Kaitlan Collins reports. 00:59 - Source: CNN ICE chief defends agents wearing masks during immigration raids Acting ICE Director Todd Lyons is defending federal immigration agents for wearing masks during raids across the US, citing safety concerns. The tactic has sparked backlash and raised questions about transparency and accountability. 00:58 - Source: CNN Dana Bash presses Trump's budget chief about cancer cuts CNN's Dana Bash presses Office of Management and Budget Director Russ Vought on the Trump administration's proposal to cut non-defense spending by more than 22% — including deep reductions to education, food assistance, and billions in cancer research funding. As Vought defends the cuts and criticizes the NIH, Bash challenges him on the real-world impact to life-saving medical research. 01:35 - Source: CNN Trump reacts to video of Macron's apparent shove from wife President Trump was asked by reporters about the viral video appearing to show French President Emmanuel Macron being pushed by his wife Brigitte as they disembarked from a plane in Vietnam. Macron, at the time, quickly dismissed the video. 00:34 - Source: CNN Trans high school athlete wins events amid controversy A transgender athlete, whose participation sparked a national controversy and a temporary rule change, took first place in two of her three events in the California High School Track and Field Championship. 01:09 - Source: CNN South Carolina voter says 'no' to moving center South Carolina has often bucked the electoral trend – voting for candidates who lost in Iowa or New Hampshire and thus helping pick which candidate will move on to the general election. CNN's Jeff Simon spoke to multiple voters at a Democrat dinner in Columbia, South Carolina about the party's leadership and future. 01:25 - Source: CNN Hegseth warns 'threat China poses is real' US Defense Secretary Pete Hegseth, speaking to Asia's premier defense forum in Singapore, delivered a dire warning to the world: China's designs on Taiwan pose a threat to global peace and stability that requires 'our allies and partners do their part on defense.' While Hegseth made clear that Washington does not seek conflict with China, he stressed the Trump administration would not let aggression from Beijing stand. 00:50 - Source: CNN GOP senator pressed on Medicaid in heated town hall GOP Sen. Joni Ernst faced concerns from town hall attendees over potential cuts to Medicaid and SNAP programs as a result of President Donald Trump's sweeping domestic policy bill, saying at one point, 'Well, we all are going to die,' and insisting that those who are eligible for Medicaid will continue to receive payments. 01:12 - Source: CNN Fareed Zakaria breaks down Trump's tariff battle CNN's Fareed Zakaria breaks down what's going on with President Donald Trump's battle with the Supreme Court over tariffs. 00:58 - Source: CNN President Trump's timeline for things seems to almost always be 'in two weeks' President Donald Trump told reporters it will take about 'two weeks' to determine whether Russian President Vladimir Putin is serious about ending the war in Ukraine. That two week timeline, CNN's Abby Phillip says, is a familiar one. 01:48 - Source: CNN President Trump is on a pardoning spree President Donald Trump used his pardon power to grant clemency to a wave of individuals who had been convicted of crimes that range from public corruption, guns and even maritime-related offenses, according to multiple officials. CNN's Kaitlan Collins reports. 00:53 - Source: CNN Trump responds to Wall Street term 'TACO': Trump Always Chickens Out President Donald Trump was asked about "TACO," an acronym that means "Trump Always Chickens Out," which is used by Wall Street workers for his on-and-off approach to tariffs. Calling it "the nastiest question," Trump defended his tariff policy by calling it "negotiation." 01:13 - Source: CNN Harvard students and faculty speak out against Trump Harvard students and faculty spoke to CNN ahead of commencement as Donald Trump said the university should cap foreign enrollment. The Trump administration has recently sought to cancel $100 million in contracts with the school. 02:03 - Source: CNN
Yahoo
an hour ago
- Yahoo
La Jolla Cosmetic Medical Spa Opens Third Location in Temecula on June 2nd
San Diego's Most Trusted Med Spa Expands to the Inland Empire with Award-Winning Aesthetic Services TEMECULA, Calif., June 5, 2025 /PRNewswire/ -- La Jolla Cosmetic Medical Spa (LJC), a leader in aesthetic care for over three decades, is proud to announce the opening of its third medical spa location in Temecula, California, which opened on Monday, June 2, 2025. This new location brings LJC's award-winning services to the heart of the Temecula Valley. Founded in 1988, the La Jolla Cosmetic brand has been a staple of San Diego's aesthetic community for 35+ years. With medical spa locations in La Jolla and Carlsbad, the practice has earned recognition as an 8-time winner of "Best of San Diego" and is currently named a Top 10 Allergan provider in the nation for injectables like BOTOX® and JUVÉDERM®. Now expanding into Riverside County, LJC continues its mission to make world-class aesthetic care more accessible across Southern California. "Opening in Temecula marks a major milestone in our mission to provide personalized, natural results and build long-term relationships with our patients across Southern California," said Lauren Amico Reed, PA-C, MMS, Co-founder of La Jolla Cosmetic Medical Spa. "We are thrilled to bring our team's expertise and renowned aesthetic care to this incredible community." The Temecula location will offer the full range of LJC's most popular non-surgical services, including: Injectables: BOTOX®, JUVÉDERM®, Sculptra®, and more Skin Rejuvenation: HALO® laser, BBL Hero®, threads, microneedling, and medical-grade facials Hair & Wellness Treatments: Regenerative treatments for hair thinning and sexual wellness injectables Patients can expect the same elevated experience that has made LJC a trusted name in aesthetics—from highly trained providers to personalized treatment plans, all in a welcoming, luxurious setting. With this new location, the brand strengthens its vision of blending clinical excellence with deep community connection. Appointments for the Temecula location can be booked at or by calling (858) 228-4542. To celebrate the launch, LJC is offering an exclusive pre-sale special: 40 units of BOTOX® for $299 for a limited time. Additionally, the official grand opening celebration will be held on Saturday, July 19, from 12 p.m. to 3 p.m. Guests can enjoy: Exciting giveaways Exclusive swag bags for the first arrivals Live treatment demos Light bites and refreshments Fun activities and a chance to tour the new space RSVP: La Jolla Cosmetic Medical Spa – Temecula Grand Opening Event! About La Jolla Cosmetic Medical SpaLa Jolla Cosmetic Medical Spa (LJC) has been helping patients look and feel their best since 2013. Known for delivering natural-looking results through expert providers, advanced technology, and personalized care, LJC sets the standard for aesthetic excellence. With medical spa locations in La Jolla, Carlsbad, and now Temecula, LJC continues to set the standard for aesthetic care in Southern California. View original content to download multimedia: SOURCE La Jolla Cosmetic Medical Spa Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
Global Antidote Market to Cross the USD 4 Billion Mark by 2032
The antidote market is witnessing substantial growth, largely propelled by the growing incidence of poisoning, drug overdoses, and snake or animal bites. This rising demand is supported by greater public health awareness, government efforts to combat drug overdoses, and continuous progress in product innovation. Moreover, strategic product launches and technological advancements by key industry players in the treatment of toxicities are further accelerating the market's upward momentum. New York, USA, June 05, 2025 (GLOBE NEWSWIRE) -- Global Antidote Market to Cross the USD 4 Billion Mark by 2032 | DelveInsight The antidote market is witnessing substantial growth, largely propelled by the growing incidence of poisoning, drug overdoses, and snake or animal bites. This rising demand is supported by greater public health awareness, government efforts to combat drug overdoses, and continuous progress in product innovation. Moreover, strategic product launches and technological advancements by key industry players in the treatment of toxicities are further accelerating the market's upward momentum. DelveInsight's Antidote Market Insights report provides the current and forecast market analysis, individual leading antidote companies' market shares, challenges, antidote market drivers, barriers, trends, and key market antidote companies in the market. Key Takeaways from the Antidote Market Report As per DelveInsight estimates, North America is anticipated to dominate the global antidote market during the forecast period. In the antidote type segment of the antidote market, the biological antidotes category accounted for the largest market share in 2024. Notable antidote companies such as Pfizer Inc., SERB Pharmaceuticals, McKesson Corporation, Amneal Pharmaceuticals LLC, EMERGENT, Novartis AG, Troikaa, Hope Pharmaceuticals, Rare Disease Therapeutics, Inc., BTG International Inc., Viatris Inc., Glentham® Life Sciences Limited, Kaleo, Inc., SGPharma Pvt. Ltd., American Regent, Inc., FFF Enterprises, Inc., Amphastar Pharmaceuticals, Inc., Purdue Pharma L.P., Indivior PLC, Harm Reduction Therapeutics, Inc., and several others are currently operating in the antidote market. In August 2024, Purdue Pharma L.P. received FDA approval for the New Drug Application (NDA) of Zurnai™ (nalmefene injection) auto-injector. In March 2024, Indivior PLC announced the results of a pharmacodynamic study showcasing that OPVEE® effectively and rapidly reverses opioid-induced respiratory depression, the primary cause of death in opioid overdoses. This breakthrough demonstrates the potential of OPVEE® as a critical intervention in emergency overdose situations, offering a swift response to prevent life-threatening complications associated with opioid toxicity. To read more about the latest highlights related to the antidote market, get a snapshot of the key highlights entailed in the Global Antidote Market Report Antidote Overview Antidote refers to a substance that counteracts the harmful effects of a poison or toxin. When an individual is exposed to a toxic substance, whether through ingestion, inhalation, injection, or skin contact, an antidote can help neutralize the toxin, reverse its effects, or support the body's natural elimination processes. Antidotes work through various mechanisms: some bind directly to the toxin, others block its biological effects, and some enhance the body's own detoxification systems. Common examples include activated charcoal for many oral poisons, naloxone for opioid overdoses, and atropine for certain nerve agent or pesticide exposures. The development and timely administration of antidotes are crucial in emergency medicine and toxicology. While some antidotes are broadly effective against a wide range of toxins, others are highly specific, targeting a single compound or class of poisons. Due to the diversity of toxic agents and the complexity of their effects on human biology, ongoing research in pharmacology and biochemistry continues to play a critical role in discovering new antidotes. In mass exposure events or cases of rare poisoning, the availability and distribution of appropriate antidotes can be a matter of life and death, underscoring their significance in public health preparedness and clinical Market Insights North America held a substantial share of the antidote market in 2024, fueled by several critical factors. The growing number of poisoning and drug overdose incidents across the region has significantly increased the need for effective antidote solutions. In particular, the opioid epidemic in the United States has driven demand for treatments like naloxone, which can reverse opioid overdoses. Public health campaigns and government-led efforts to curb and manage drug overdoses have further enhanced access to antidotes. Moreover, the market is witnessing a boost from ongoing pharmaceutical innovation and the introduction of new, targeted treatments. In response to this concerning trend, regional authorities have launched various initiatives to address drug overdoses and poisoning. For example, the U.S. Food and Drug Administration (FDA) implemented the Overdose Prevention Framework, which aims to reduce unnecessary opioid prescriptions, encourage harm-reduction strategies through education and innovation, and support the development of evidence-based therapies for substance use disorders and overdoses. Canada is also actively combating the overdose crisis. The Canadian government is investing in prevention programs, expanding access to treatment and harm-reduction services, and leveraging data-driven approaches to guide policy-making. These comprehensive efforts are fostering an environment conducive to the growth of the antidote market across North America. Additionally, pharmaceutical companies in the region are intensifying research and development efforts to bring advanced overdose treatments to market. For instance, in August 2024, Purdue Pharma L.P. received FDA approval for its New Drug Application (NDA) for Zurnai™ (nalmefene injection) auto-injector. This product is designed for emergency use in opioid overdoses caused by both natural and synthetic opioids in adults and adolescents aged 12 and above. The approval of Zurnai™ has expanded the arsenal of available opioid overdose antidotes, offering a fast-acting, user-friendly option to help tackle the ongoing opioid crisis. To know more about why North America is leading the market growth in the antidote market, get a snapshot of the Antidote Market Outlook Antidote Market Dynamics The antidote market is a crucial segment of the global pharmaceutical and toxicology landscape, driven by the increasing incidence of poisoning cases from pharmaceuticals, snake bites, chemical exposure, and overdoses. With growing awareness about drug misuse and rising environmental hazards, the demand for antidotes has surged in both developed and developing countries. Additionally, the rise in hospital admissions due to opioid overdoses, especially in North America and parts of Europe, has directly increased the need for effective and rapid-response antidotes like naloxone. One of the primary market dynamics shaping the antidote sector is the regulatory landscape. Antidotes, often falling under emergency-use drugs, receive fast-track approvals in certain jurisdictions due to their life-saving potential. Governments and healthcare bodies have also begun stockpiling critical antidotes as part of national preparedness programs, especially in regions vulnerable to snake bites or chemical attacks. Furthermore, innovations in biotechnology have allowed the development of more targeted and efficient antidotes, including monoclonal antibodies and small molecule inhibitors tailored for specific toxins or venoms. However, the market faces significant challenges. Many antidotes are expensive to develop and maintain, especially when the target population is small or geographically limited. For example, antivenoms for rare snake species may not be commercially viable due to high R&D costs and limited demand. This has led to a reliance on public-private partnerships and NGO involvement to ensure production and distribution in low-income areas. Moreover, the shelf-life and storage requirements of many antidotes add to supply chain complexity, often limiting their availability in remote or underdeveloped regions. Looking ahead, the antidote market is expected to benefit from increased global focus on public health preparedness and bioterrorism defense. The COVID-19 pandemic underscored the importance of rapid medical response capabilities, prompting governments to revisit their emergency drug inventories. Additionally, as pharmaceutical companies invest in advanced drug delivery systems and synthetic biology, novel antidotes with longer shelf lives and broader efficacy profiles are likely to emerge. The integration of digital health tools and AI in toxicology response systems could also streamline the identification and administration of antidotes, improving patient outcomes and operational efficiency in emergency care. Get a sneak peek at the antidote market dynamics @ Antidote Market Trends Report Metrics Details Coverage Global Study Period 2022–2032 Antidote Market CAGR ~7% Antidote Market Size by 2032 USD 4 Billion Key Antidote Companies Pfizer Inc., SERB Pharmaceuticals, McKesson Corporation, Amneal Pharmaceuticals LLC, EMERGENT, Novartis AG, Troikaa, Hope Pharmaceuticals, Rare Disease Therapeutics, Inc., BTG International Inc., Viatris Inc., Glentham® Life Sciences Limited, Kaleo, Inc., SGPharma Pvt. Ltd., American Regent, Inc., FFF Enterprises, Inc., Amphastar Pharmaceuticals, Inc., Purdue Pharma L.P., Indivior PLC, Harm Reduction Therapeutics, Inc., among others Antidote Market Assessment Antidote Market Segmentation Antidote Market Segmentation By Type: Chemical Antidotes and Biological Antidotes Antidote Market Segmentation By Route of Administration: Oral and Parenteral Antidote Market Segmentation By Distribution Channel: Hospital and Retail Pharmacies Antidote Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the antidote market are set to emerge as the trendsetter explore @ Antidote Companies Table of Contents 1 Antidote Market Report Introduction 2 Antidote Market Executive Summary 3 Competitive Landscape 4 Regulatory Analysis 5 Antidote Market Key Factors Analysis 6 Antidote Market Porter's Five Forces Analysis 7 Antidote Market Layout 8 Antidote Market Company and Product Profiles 9 KOL Views 10 Project Approach 11 About DelveInsight 12 Disclaimer & Contact Us Interested in knowing the antidote market by 2032? Click to get a snapshot of the Antidote Market Analysis Related Reports Heavy Metal Poisoning Market Heavy Metal Poisoning Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key heavy metal poisoning companies, including EmeraMed, Magellan Diagnostics, Bezoloven Inc., among others. Substance Use Disorder Market Substance Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SUD companies including BioXcel Therapeutics, NFL Biosciences, STALICLA, Embera NeuroTherapeutics, PleoPharma, Kinnov Therapeutics, Imbrium Therapeutics, Atai Life Sciences, Beckley Psytech, among others. Opioid Use Disorder Market Opioid Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key OUD companies including Indivior PLC, Alkermes, Orexo AB, Titan Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., Mallinckrodt Pharmaceuticals, BioDelivery Sciences International Inc., Viatris Inc., Pfizer, Inc., Hikma Pharmaceuticals PLC, Camurus, among others. Cocaine Use Disorder Market Cocaine Use Disorder Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CUD companies including STALICLA, Embera NeuroTherapeutics, among others. Cocaine Intoxication Market Cocaine Intoxication Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cocaine intoxication companies including Tonix Pharmaceutical, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. CONTACT: Contact Us Shruti Thakur info@ +14699457679Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
