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 announced the publication of the Company's Universal registration document ("URD") for the year ended December 31, 2023.
The document, filed with the French stock-market authority (Autorité des Marchés Financiers) on April 30, 2023, is available to the public free of charge upon request, as per current legal regulations; and on the Company's website under the section Investors Documentation, as well as on that of the AMF (www.amf-france.org).
It notably includes the 2023 annual financial report, the report on corporate governance, the required information in relation to the share repurchase program, as well as the statutory auditor' reports and information on the fees paid to the statutory auditor in 2023. The URD is available in French only, but for the convenience of English-speaking readers, CARMAT provides a free translation into English of its 2023 financial statements1, which is available in the English section of its website.
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.
Name: CARMAT
ISIN code: FR0010907956
Ticker: ALCAR
Disclaimer
This press release and the information contained herein do not constitute an offer to sell or subscribe, nor a solicitation of an order to buy or subscribe to CARMAT shares in any country. This press release may contain forward-looking statements by the company regarding its objectives and prospects. 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 such as the company's ability to implement its strategy, the pace of development of CARMAT's 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 objectives mentioned in this press release may not be achieved due to these elements or other risk factors and uncertainties.
Significant and specific risks of the company are those described in its universal registration document filed with the French Financial Markets Authority (Autorité des marchés financiers the "AMF") under number D.23-0374. Readers' attention is particularly drawn to the fact that the company's current cash runway is limited to mid-May 2024. Readers and investors are also advised that other risks, unknown or not considered significant and specific, may or could exist.
Aeson is an active implantable medical device commercially available in the European Union and other countries recognizing CE marking. The Aeson total artificial heart is intended to replace the ventricles of the native heart and is indicated as a bridge to transplant for patients suffering from 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 undergo 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 manual, patient manual, and alarm booklet) should be carefully read to understand the features of Aeson and the information necessary for patient selection and proper use (contraindications, precautions, side effects). In the United States, Aeson is currently exclusively available as part of an Early Feasibility Study approved by the Food Drug Administration (FDA).
1 Corresponding to Section 3.2 of the URD.
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Contacts:
CARMAT
Stéphane Piat
Chief Executive Officer
Pascale d'Arbonneau
Chief Financial Officer
Tel.: +33 1 39 45 64 50
contact@carmatsas.com
Alize RP
Press Relations
Caroline Carmagnol
Tel.: +33 6 64 18 99 59
carmat@alizerp.com
NewCap
Financial Communication
& Investor Relations
Dusan Oresansky
Jérémy Digel
Tel.: +33 1 44 71 94 92
carmat@newcap.eu
