PARIS–(BUSINESS WIRE)–Regulatory News:
CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), designer and developer of Aeson®, the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from advanced biventricular heart failure, provides a business update, and communicates its financial targets for the first time.
Sales forecast of €10 to €13 million in 2023
CARMAT resumed commercial implants of its Aeson® artificial heart in November 2022. The Company continues to train additional hospitals very actively, and targets 30 operational centers in Europe by the end of 2023, primarily in Germany and Italy.
In France, Aeson® will be made available to patients via the EFICAS study, which was initiated last December, in 6 hospitals: Lille Regional University Hospital, Pitié Salpêtrière University Hospital and Georges Pompidou European Hospital in Paris, Rennes University Hospital, Strasbourg University Hospital and Lyon University Hospital (Hospices Civils de Lyon). The Company aims to complete the study in 2025.
The production ramp-up will be gradual and should allow more than 100 artificial hearts to be produced in 2023.
Based on this, the Company forecasts sales of €10 million to €13 million in 2023.
Break-even anticipated in 2027
Moreover, in order to support a strong demand for Aeson® in Europe, and its commercial launch in the United States, anticipated in 2026, CARMAT has planned an ambitious industrial plan which should enable the Company to achieve a manufacturing capacity of 500 prostheses in 2024 and 1,000 prostheses by 2027.
Based on this, the Company anticipates to be in position to achieve break even within 5 years, i.e. in 2027.
Stéphane Piat, Chief Executive Officer of CARMAT, commented: “The last few months have been full of valuable learnings and have allowed us to fine-tune our market access and our industrial strategies. Given the progress made in various areas (commercial, manufacturing, quality, clinical, etc.), we are now in a position – for the first time – to communicate financial targets, and in particular revenue guidance of 10 to 13 million euros for 2023. Strong interest in, and demand for Aeson® make us particularly confident about the development of our sales. Our entire team is more determined than ever to make Aeson® the new benchmark treatment in advanced biventricular heart failure, to successfully ramp up our production, and so embark on the journey to profitable growth”.
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 more than 200 highly specialized people. CARMAT is listed on the Euronext Growth market in Paris (Ticker: ALCAR / ISIN code: FR0010907956).
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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. 22-0332. 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).