CARMAT Announces the First Commercial Implants of Its Aeson® Artificial Heart Outside the European Union
PARIS--(BUSINESS WIRE)--Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the world's most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure (the ' Company ' or ' CARMAT '), today announces the first implants of its Aeson® artificial heart in a commercial set-up, outside the European Union (EU).
Two implants of Aeson® artificial heart were performed during the week commencing May 26, 2025 in Israel.
The first one was carried out at Hadassah Ein Kerem Hospital in Jerusalem by a team led by Pr Offer Amir, Pr Rabea Asleh and Dr Amit Korach, respectively director of the Heart Institute, director of heart failure unit and director of the cardiac surgery department at Hadassah Medical Center.
The second one was carried out at Sheba Medical Center in Ramat Gan (Tel Aviv), by a team led by Dr Jeff Morgan, Dr Leonid Sternik, Dr Alex Fardman and Dr Eyal Nachum, respectively head of mechanical support unit, director of cardiac surgery department, heart failure cardiologist and cardiac transplant surgeon.
Those are the first Aeson® implants made in a commercial set-up outside the European Union.
These implants bring to 5 the total number of countries 1 where commercial implants have been performed so far. They confirm the trust placed in the device by healthcare professionals, and the growing interest in the therapy.
About CARMAT
CARMAT is a French MedTech that designs, manufactures and markets the Aeson ® artificial heart. The Company's ambition is to make Aeson ® the first alternative to a heart transplant, and thus provide a therapeutic solution to people suffering from end-stage biventricular heart failure, who are facing a well-known shortfall in available human grafts. The world's first physiological artificial heart that is highly hemocompatible, pulsatile and self-regulated, Aeson ® could save, every year, the lives of thousands of patients waiting for a heart transplant. The device offers patients quality of life and mobility thanks to its ergonomic and portable external power supply system that is continuously connected to the implanted prosthesis. Aeson ® is commercially available as a bridge to transplant in the European Union and other countries that recognize CE marking. Aeson ® is also currently being assessed within the framework of an Early Feasibility Study (EFS) in the United States. Founded in 2008, CARMAT is based in the Paris region, with its head offices located in Vélizy-Villacoublay and its production site in Bois-d'Arcy. The Company can rely on the talent and expertise of a multidisciplinary team of circa 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).
For more information, please go to www.carmatsa.com and follow us on LinkedIn.
Disclaimer
This press release and the information it contains do not constitute an offer to sell or subscribe, nor a solicitation of an offer to buy or subscribe, for CARMAT shares in any country.
This press release may contain forward-looking statements regarding the Company's objectives and outlook. These forward-looking statements are based on the current estimates and anticipations of the Company's management and are subject to risk factors and uncertainties, including those described in its Universal Registration Document filed with the French Financial Markets Authority (Autorité des marchés financiers) (the 'AMF') under number D.25-0345 (the ' 2024 Universal Registration Document '), available free of charge on the websites of CARMAT (www.carmatsa.com/en/) and the AMF (www.amf-france.org).
Readers' attention is particularly drawn to the fact that the Company's current cash runway is limited to mid-June 2025 (excluding the flexible equity financing line entered into with IRIS, which was announced on March 27, 2025). The Company is also subject to other risks and uncertainties, such as its ability to implement its strategy, the pace of development of its production and sales, the pace and results of ongoing or planned clinical trials, technological evolution and competitive environment, regulatory changes, industrial risks, and all risks associated with the Company's growth management. The Company's forward-looking statements mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties, whether unknown or not considered material and specific by the Company as of today.
Aeson® is an active implantable medical device commercially available in the European Union and other countries recognising the CE mark. The Aeson® total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant in patients with end-stage biventricular heart failure (Intermacs classes 1-4) who cannot benefit from maximal medical therapy or a left ventricular assist device (LVAD) and who are likely to benefit from a heart transplant within 180 days of implantation. The decision to implant and the surgical procedure must be carried out by healthcare professionals trained by the manufacturer. The documentation (clinician's manual, patient's manual and alarm booklet) must be read carefully to learn about the characteristics of Aeson® and the information required for patient selection and proper use (contraindications, precautions, side effects) of Aeson®. In the United States, Aeson® is currently only available as part of a feasibility clinical trial approved by the Food & Drug Administration (FDA).
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Upturn
an hour ago
- Business Upturn
OCUFA Challenges Ontario Government's Narrative on Postsecondary Funding Crisis, Welcomes Review with Call for Meaningful Faculty Consultation
TORONTO, ON, June 21, 2025 (GLOBE NEWSWIRE) — The Ontario Confederation of University Faculty Associations (OCUFA) today responded to the announcement by Minister of Colleges, Universities, Research Excellence and Security (MCURES) Nolan Quinn of $55.8 million to expand teaching training seats across Ontario. While OCUFA welcomes any new investment in the postsecondary sector, the organization asserts that the Ontario government is not taking meaningful action to address the deep-seated financial crisis facing Ontario's world-class public universities. Minister Quinn highlighted that the investment would train up to 2,600 new teachers by 2027, prioritizing accelerated programs, French and technological education, and seats in northern, rural, Indigenous, and remote regions. However, when asked on the broader financial challenges confronting the sector, Minister Quinn attributed these issues to 'unilateral decisions' by the federal government regarding international student study permits. 'The financial struggles plaguing Ontario's postsecondary education sector are not a sudden development, nor are they solely a result of federal changes to international student permit caps', stated OCUFA President Nigmendra Narain. 'For decades, Ontario's universities have endured chronic underfunding, consistently ranking dead last in Canada in per-student funding. We are disappointed to see the Ontario Government downplay its own responsibility in supporting this vital sector.' OCUFA is deeply concerned that Ontario's universities are currently grappling with program closures, enrollment pauses, increasing precarity among faculty, and significant challenges in funding the province's most promising talent. The undergraduate programs that produce the students who enter teacher's college are not only underfunded, but are now facing cuts, limiting the academic preparation of teachers. While the $55.8 million for teaching pathways is a positive step, OCUFA emphasizes that these recent commitments only scratch the surface of the sector's needs. To simply reach Canada's national per-student funding average, Ontario requires an immediate investment of at least $2.78 billion, possibly more depending on the impact of declining international student enrolment. Without substantial and ongoing funding commitments, Ontario's position as a world leader in postsecondary education, research, and scholarship will continue to be at jeopardy. OCUFA welcomes the Minister's announcement that his ministry will be reviewing how funding is delivered across the postsecondary sector. 'We sincerely hope for meaningful consultation during this process and that the Ontario Government will ensure the voices of university faculty and academic librarians across the province are not only heard but respected,' said OCUFA Executive Director Jenny Ahn, echoing recommendations made at OCUFA's Funding Our Future: Keeping Universities Public conference in 2023. Founded in 1964, OCUFA represents more than 18,000 professors and academic librarians in 30 faculty associations across Ontario. It is committed to enhancing the quality of higher education in Ontario and recognizing the outstanding contributions of its members towards creating a world-class university system. For more information, please visit the OCUFA website at Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash
Bloomberg
10 hours ago
- Bloomberg
EU Frets Over US Demands in Trade Talks It Sees as Unbalanced
The US is demanding the European Union make what the bloc's officials see as unbalanced, unilateral concessions as part of ongoing trade talks, setting up a tough decision over whether to move ahead with countermeasures if the terms of any deal don't improve. The best-case scenario remains an agreement on principles that would allow the negotiations to continue beyond an early July deadline, according to people familiar with the matter.
Yahoo
11 hours ago
- Yahoo
Niger to nationalise uranium mine operated by French state-affiliated firm
Niger plans to nationalise a uranium mine operated by French nuclear firm Orano as it continues to pivot away from former colonial ruler, France. The company, which is 90 percent owned by the French state, said on Friday that Niger's military rulers' planned nationalisation of the Somair mine was part of a 'systematic policy of stripping mining assets', threatening to take legal action over the move. The military government – which came to power in a 2023 coup, pledging to review mining concessions – had said a day prior that it intended to take control of the Somair mine, accusing Orano of taking a disproportionate share of uranium produced at the site. Orano holds a 63 percent stake in Somair, while Niger's state-owned Sopamin owns the remainder, but the government said that Orano had taken 86.3 percent of production between the mine's launch in 1971 and 2024. 'Faced with the irresponsible, illegal, and unfair behaviour by Orano, a company owned by the French state, a state openly hostile toward Niger since July 26, 2023 … the government of Niger has decided, in full sovereignty, to nationalise Somair,' the authorities said on military leaders have turned their back on France since taking power, seeking closer ties with Russia instead. In 2024, Niger removed Orano's operational control of its three main mines in the country: Somair, Cominak and Imouraren, which has one of the largest uranium deposits in the world. On Friday, Orano said it intended 'to claim compensation for all of its damages and assert its rights over the stock corresponding to Somair's production to date'. Orano, which has been operating in Niger for 50 years, is involved in several arbitration processes with the country. Last month, it sued the Nigerien authorities after the disappearance of its director and the raiding of its local offices. Niger's decision to nationalise Somair comes amid a wave of mine nationalisations across West Africa, notably in Mali and Burkina Faso, both of which are governed by military governments.
