TECHEU VD TENSIVE (BIOTECH ACT)

The project concerns the promoter's research and development activities and CAPEX expenditures to advance regenerative implants for reconstructive surgery and for tissue marking following lumpectomy or mastectomy in breast cancer patients.

The project focuses on the development, clinical validation, and regulatory approval of REGENERA/SOFTAG, an innovative bioresorbable implant and precision tissue marker designed to support tissue regeneration following lumpectomy (i.e., partial breast removal after breast cancer). In parallel, the associated R&D investments also encompass clinical research into a novel post-mastectomy indication (i.e., full breast removal after breast cancer), leveraging advanced biomaterial 3D printing technology to enable the development of next-generation reconstructive implants.

The operation contributes to 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 the research, development and innovation (RDI) activities of a medical technology company developing innovative bioresorbable materials for soft tissue regeneration.

The financing of this project addresses a failure in financial markets for RDI, stemming from limited access to appropriate long-term funding due to factors such as information asymmetries, high development risk and the absence of collateral typical of early-stage medtech companies. By generating substantial knowledge externalities in a field with significant unmet medical need, the project is expected to deliver socio-economic benefits, strengthen Europe's position in medtech research and contribute to the creation and retention of highly skilled jobs.

Thanks to the support of InvestEU, the EIB is able to provide long-term venture debt financing to a highly innovative company that currently lacks access to commercial debt. By extending the company's cash runway and de-risking the execution of its development plan, the EIB financing is expected to attract additional private investment and support continued growth. The project could not be financed (to the same extent) by the EIB without 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 requires that all project contracts are procured in accordance with the applicable EU procurement legislation.