Project Portugal 2030

Summary

Currently used AVGs (e.g. ePTFE) present some drawbacks such as size and compliance mismatch, damage by repeated punctures, long-term neointima proliferation, stenosis and thrombosis. Therefore, there is the need to develop at the R&D level and further clinical testing of bioengineered VA in patients with end-stage CKD (Vachharajani et al., 2021). The implementation of the previously described innovative approaches will allow to conveniently overcome such disadvantages, nurturing the LEAVE project ambition to develop a safe and effective HD access solution. LEAVE’s solution will not require the harvesting of an artery-vein segment in a second location with undesirable side effects, as in the case of AVF. Consequently, LEAVE sets the following multidimensional specific objectives: - Technological and Scientific: (i) produce an AV graft composed of an inner tubular fibrous layer and an outer silicon rubber layer, with morphological and mechanical properties similar to native vessels and capable of resisting to multiple needle punctures; (ii) functionalize the inner layer of the AV graft enabling the recruitment of autologous circulating ECFCs; (iii) validate the hemocompatibility of the biofunctional AV graft under simulated physiological conditions; (iv) validate the efficacy of the biofunctional AV graft in a preclinical animal model (i.e. pig). - Economical: (i) protect the generated intellectual property rights (IPR) in the form of patents, trademarks and future business plans; (ii) translate of innovative research to knowledge-intensive high-added-value innovative products; (iii) boost competitiveness and leadership in the AVG segment of the HD market. - Societal: (i) publication of research data in peer-reviewed journals under open access; (ii) communication of research data in international scientific conferences and/or medical fairs; (iii) promote networking between academia and clinics; (iv) improve the patient´s well-being, health and quality of life providing a long-term solution for HD access. By materializing the technological and scientific objectives, LEAVE’s project will address the initial developmental (i.e. preclinical) stage of a potential medical device, in accordance with the Regulation (EU) 2017/745. Their outputs will be essential to fulfill a technical dossier that will be further subject to conformity assessment by the regulatory entity (the Notified Body). The economic objectives are essential in purposing a novel technology for further exploitation in the medical devices space. The protection of the unique research findings is fundamental in the definition of an exploitable asset, which will attract the attention of HD companies and/or investors. Parallelly to previous objectives, the dissemination of research and technological outputs through different communication channels will significantly increase the LEAVE’s visibility aiming to reach the different stakeholders (researchers, physicians, potential investors, HD patients) of the value chain. Concluding, all previously defined objectives will tackle the developmental aspects of an innovative technology for HD access.