The promoter, a French pre-commercial-stage medtech company is the designer and developer of an advanced cardio-vascular prosthetic device. The project supported by the Bank concerns the promoter's research and development (R&D) investments across several EU countries (e.g. France, Denmark, the Czech Republic), over the years 2018-2022. The EIB's funding will be mainly used to complete the prosthesis CE labelling, prepare its market-access and strengthen the company's manufacturing processes and capacities.
With its total artifical heart, the company aims to offer a permanent solution to patients with terminal heart failure who are facing a therapeutic stalemate due to the lack of human grafts. The EIB will contribute to the financing of the clinical validation and regulatory approval of the prosthesis, the development of the technologies and know-how in order to improve further the prosthesis and the patient's quality of life, the improvement of the Company's manufacturing process and its manufacturing capacities as well as the development of the marketing and sales teams in the market access phase.
The project mainly concerns investments in R&D that are expected to be carried out in existing facilities already authorised for the same purpose and would therefore not require an Environmental Impact Assessment (EIA) under Directive 2011/92/EU. Full environmental details have been verified during the appraisal and are aligned with best practices.
The promoter is a private company which does not operate in the utilities sector and which does not have the status of a contracting authority. Thus, it is not covered by EU Directives on procurement. However, the promoter's procurement procedures are expected to be in line with EIB guidelines for private sector projects. The Bank's services verified the details during the project due diligence.
Before financing approval by the Board of Directors, and before loan signature, projects are under appraisal and negotiation. The data provided on this page is therefore indicative and cannot be considered to represent official EIB policy (see also the Explanatory notes).
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