CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to provide a therapeutic alternative for people suffering from end-stage biventricular heart failure, and the European Investment Bank (EIB), which is the bank of the European Union (EU), today announce the signing of a €30 million loan agreement supported by the European Fund for Strategic Investments (EFSI), the central pillar of the Investment Plan for Europe – more commonly known as the Juncker Plan.

This loan will support the strategic transformation of CARMAT into an industrial and commercial company via the completion of clinical trials and an increase in its production capacity. The agreement was signed by Ambroise Fayolle, Vice-President of the EIB, and Stéphane Piat, CEO of CARMAT, during a visit of the new automated manufacturing site in Bois-d’Arcy, near Paris.

The aim of this type of non-dilutive financing, granted by the EIB with the European guarantee within the framework of the Juncker plan, is to support research and innovation projects developed by companies with substantial growth potential. The CARMAT project meets these criteria as, assuming clinical trials are successful, its bioprosthesis could become a credible alternative to a heart transplant for tens of thousands of patients facing the well-known shortfall in available organs.

After having provided the proof of concept of its device in a feasibility study, CARMAT is currently evaluating its bioprosthesis within the framework of an international PIVOTAL study that foresees the inclusion of approximately 20 patients, the second part of this study having begun during the second half of 2018. In Europe, the study is conducted in various countries within cardiac centers of excellence and helps, with this unique medical device, to enhance surgeons’ know-how in caring for patients suffering from heart failure. This project will also have a positive impact on skilled employment. Indeed, CARMAT, which currently employs 180 permanent staff, is planning to double this number by 2025, principally in R&D.

This financing will support the clinical evaluation of the CARMAT bioprosthetic heart through to the granting of CE marking, which is expected in 2019, as well as industrial developments and preparations for the commercial phase.

This European financing will support the marketing process of the world’s most advanced total artificial heart while helping increase the production capacities of CARMAT. By accompanying the transformation of this highly-innovative Med Tech into an industrial and commercial company, we are providing CARMAT with the means to develop and potentially become a global champion in the field of artificial hearts,” says Ambroise Fayolle, Vice-President of the EIB, and addsMed Techs are a key vehicle for innovation that requires substantial investments during the clinical development phase. This is why we provide them with bespoke financing adapted to their specific requirements and their clinical phases. That is the added value of the Juncker plan!

Pierre Moscovici, Head of Economic and Financial Affairs for the European Commission adds:I am delighted about this new loan to French company CARMAT within the Juncker Plan. Artificial hearts developed by this company raise immense hope. This is concrete evidence that the Juncker Plan fosters innovation in health for the benefit of European citizens and gives French innovation excellence the opportunity to shine.”

Stéphane Piat, CEO of CARMAT, concludes:We are very pleased about this financing agreement with the EIB, and I would like to thank all of the stakeholders who contributed to its realization. This operation allows us to diversify our sources of financing and will contribute to the gradual transformation of CARMAT into a European industrial and commercial company. We now have the necessary resources to complete the CE marking process, and remain confident in our ability to offer an innovative therapy to patients suffering from end-stage heart failure.”