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The project will support the promoter's research, development and innovation (RDI) activities, including product development and clinical trials.
The aim is to develop an innovative transcatheter tricuspid valve to treat tricuspid regurgitation.
The project is in line with the InvestEU objective of research, development, and innovation. The purpose of the loan is to provide direct, equity-type financing under the EIB's Venture Debt Instrument to support research, development, and innovation (RDI) activities of an innovative European MedTech company, which is developing a minimally invasive tricuspid valve replacement system designed to eliminate Tricuspid Regurgitation and improve patient outcomes
This project would ease financial constraints for a smaller innovative company which arise from information asymmetries pertaining to the company's lack of track record and of the market potential of their innovation. The financing of this project would mitigate the limited access to financial markets for the Company to adequately fund its scientific research due to the high risks involved and the general lack of collateral.
Additionally, The EIB has structured its financing to mirror a convertible loan, combining long-term debt with warrants to align returns with equity investors. By funding part of the investment plan, it supports the upcoming funding round and extends the borrower's cash runway.
The public health benefit is expected to be high as the Company is targeting an area of unmet need. Many patients do not have the option for a valve repair due the severity of the tricuspid value disease. Even of patients who are eligible for value repair, few patients achieve complete resolution of the problem. The Company's product allows full restoration of the valve's function and therefore provides better clinical outcomes with lower hospitalization rates.
The project would not have been carried out to the same extent by the EIB without the InvestEU support.
The specific RDI activities included in the project are expected to be performed in existing facilities without changing their already authorised scope. Therefore, the project activities would not require an Environmental Impact Assessment (EIA) under the Directive 2014/52/EU (amending the Directive 2011/52/EU). Full environmental details will be verified during appraisal.
The promoter is a private company not operating in the utilities sector and not having the status of a contracting authority. Thus, it is generally not covered by EU directives on procurement. However, the EIB will require that all project contracts are procured in accordance with the applicable EU procurement legislation. The Bank's services will verify details during the project due diligence.