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, today announces that it has obtained non-dilutive financing of €13.2 million as part of the “France 2030” plan, and the extension of its cash runway through to mid-October 2023.
Non-dilutive financing of €13.2 million to increase and optimize production
The purpose of the financing of €13.2 million obtained by CARMAT as part of the “Industrialisation et Capacités Santé 2030” call for proposals is to support the increase in the annual production capacity of Aeson® artificial hearts to 1,000 a year within 5 years, and the reduction of the production cost of the prosthesis.
It consists of a €7.9 million grant and a €5.3 million repayable advance. The total financing will be received in four tranches over 2023-2026, in accordance with the project’s progress. The Company anticipates to receive a first tranche of €3.3 million no later than in the third quarter of 2023.
Subject to the success of the project, the repayable advance will be reimbursed over a period of 5 years starting on September 30, 2029.
Cash runway extended to mid-October 2023
Based exclusively on its current financial resources1, including the €3.3 million first tranche of the “Industrialisation et Capacités Santé 2030” financing, CARMAT can fund its activities, according to its updated Business Plan, until mid-October 2023 without the need for any further financing.
Moreover, the Company continues to work on additional financing options to extend its cash runway beyond that date.
Stéphane Piat, Chief Executive Officer of CARMAT, commented: “This significant funding further demonstrates the French State’s confidence in the strength of our project and the potential of our Aeson® artificial heart. Not only is it crucial to enable us to rapidly increase our production capacity, it will also help us – via its optimization – to considerably reduce our prosthesis’ production cost. In this way, we will be able to meet the substantial demand from the medical community, and thus enable a large number of patients to benefit from our therapy, while embarking on the road to profitable growth. We are also very proud to be able to contribute to the reindustrialization and the growth of employment in France”.
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).
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).
1 Including its available cash, the €3.3 million first tranche of the “Industrialisation et Capacités de Santé 2030” financing due to be received no later than in the third quarter of 2023 and €2.1 million in Research Tax Credit (relative to 2022), half of which should be received during the first half of 2023 and the balance by October 2023, but excluding the potential equity financing of up to €15 million obtained in December 2022 as part of the “EIC Accelerator” program, as the latter is not certain. Discussions between CARMAT and the EIC regarding this funding are continuing, with the outcome expected by the end of the first half of 2023; obtaining this €15 million would enable CARMAT to extend its cash runway, according to its updated Business Plan, to end-December 2023.