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The project will finance research & development (R&D) to further develop a robotic medical technology using high-intensity focused ultrasound to treat various medical conditions such as prostate cancer and endometriosis.
The project focuses on the development of Focal One, an innovative device for prostate cancer treatment which leverages the High Intensity Focused Ultrasound technology (HIFU). The project also entails R&D, including clinical research, for specific new applications and treatments such as Endometriosis and Benign Prostate Hyperplasia (BPH).
The project is aligned with the InvestEU objective of promoting research, development and innovation. The purpose of the loan is to provide direct equity-type financing under InvestEU , benefiting from the EC guarantee, to finance research and development activities of an innovative medtech company EDAP. The project, if successful, is expected to have significant financial and broader social benefits, in terms of improved health and welfare. EDAPs expertise lies in applying high intensity focal ultrasound in a very precise way to cancer nodes in the prostate. Other applications are under clinical assessment. By supporting the promoter, the EIB enables the generation of European scientific knowledge and acumen, whilst preserving highly skilled employment opportunities. The financing of this project addresses the failure in financial markets for RDI-driven European SMEs suffering from systemic shortages of large, non-dilutive financing options for growth investments. Currently, the Company does not have access either to non-dilutive or to long-term debt funding sources from traditional or even alternative debt providers.
The financing structure is adjusted to the investment needs of the Company, with a long tenor and deferred interest, while most of the EIB remuneration will come in a form of warrants, minimising cash outflows. By contributing to extending the cash runway and therefore to de-risking the
development plan of the company, the EIB financing is expected to crowd-in third party investors and allow the company to accelerate its development. The project would not have been carried out (to the same extent) by the EIB without the InvestEU support.
The project would not require an Environmental Impact Assessment (EIA) under Directive 2014/52/EU amending the Directive 2011/92/EC as research, development and innovation activities will be carried out in facilities already authorised for the same purpose. Full environmental details will nevertheless be verified to align with EU best practices.
The EIB will require that all project contracts are procured in accordance with the applicable EU procurement legislation.