The facility and its equipment meet the highest standards for the production of medical devices
Its opening will enable the Company to reach a production capacity of 500 hearts per year as early as 2024, in line with its objectives
PARIS, December 04, 2023--(BUSINESS WIRE)--Regulatory News:
CARMAT (FR0010907956, ALCAR), designer and developer of the world's most advanced total artificial heart, aimed at providing a therapeutic alternative for patients suffering from advanced biventricular heart failure (the "Company" or "CARMAT"), today announced the opening of its second production facility ("BDA2") in Bois-d'Arcy, in the immediate vicinity of the Company's first production facility ("BDA1").
The works have now been completed, and the entire facility has been reviewed by the notified body DEKRA, which in mid-November 2023 approved it for the production of the Aeson® total artificial heart.
This 1,500 m2 building, which meets the highest medical device production standards, will enable CARMAT to significantly increase its capacity in terms of:
assembly of the electronic parts of the Aeson® heart,
microbiological testing of the product and the manufacturing process,
receiving and checking incoming components,
storage and shipping.
Combined with the extension of the clean room which is currently being completed in the "BDA1" facility, the opening of the "BDA2" facility will enable the Company to reach an annual production capacity of 500 hearts by early 2024, as planned.
Stéphane Piat, Chief Executive Officer of CARMAT, comments: "The opening of our new production facility is a major achievement, and I would like to thank all the teams who have worked relentlessly to ensure that it is delivered on schedule before the end of 2023. Today, with the historical "BDA1" facility and this new "BDA2" facility, we have a high-performance manufacturing tool that is certified to produce up to 500 hearts per year from 2024. In line with our strategic plan, we will further develop our industrial set-up over the next few years, to reach an annual production capacity of 1,000 Aeson® hearts by 2027."
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).
ISIN code: FR0010907956
This press release and the information contained herein do not constitute an offer to sell or subscribe to, or a solicitation of an offer to buy or subscribe to, shares in CARMAT (the "Company") in any country. This press release may contain forward‐looking statements that relate to the Company’s objectives and prospects. Such forward‐looking statements are based solely on the current expectations and assumptions of the Company’s management and involve risk and uncertainties including, without limitation, the Company’s ability to successfully implement its strategy, the rate of development of CARMAT’s production and sales, the pace and results of ongoing and future clinical trials, new products or technological developments introduced by competitors, changes in regulations and risks associated with growth management. The Company’s objectives as mentioned in this press release may not be achieved for any of these reasons or due to other risks and uncertainties.
The significant and specific risks pertaining to the Company are those described in the Universal Registration Document ("Document d’Enregistrement Universel") filed with the Autorité des Marchés Financiers (AMF, the French stock market authorities) under number D. 23-0323. Readers and investors’ attention is, however, drawn to the fact that other risks, unknown or not deemed to be significant or specific, may or could exist.
Aeson® is an active implantable medical device commercially available in the European Union and other countries that recognize 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 in patients suffering from end-stage biventricular heart failure (INTERMACS classes 1-4) who are not amenable to maximal medical therapy or a left ventricular assist device (LVAD) and are likely to undergo a heart transplant within 180 days of the device being implanted. 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 read carefully to understand the characteristics of Aeson® and information necessary for patient selection and the proper use of Aeson® (contraindications, precautions, side effects). In the United States, Aeson® is currently exclusively available within the framework of an Early Feasibility Study authorized by the Food & Drug Administration (FDA).
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