Fiche récapitulative
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 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.