Revolutionising the world of hemodialysis with a novel, hybrid, silk fibroin/polyurethane vascular access

ended

Vascular access is the bottleneck to long-term hemodialysis for about 2.2 million people worldwide who need this life-saving/life-sustaining therapy in case of renal failure, e.g. as a consequence of diabetes and/or hypertension. The current alternatives of vascular access suffer in fact from several limitations, e.g. the need for frequent and costly re-interventions, reduced patency, infective complications. To meet this urgent, global, clinical need, BEL proposes SAG (Silkothane® Arteriovenous Graft), an innovative, hybrid, semidegradable, nanostructured vascular access, manufactured by electrospinning using Silkothane®, a silk fibroin/polyurethane blend developed and trademarked by BEL under the auspices of a MSCA action. Enabling early cannulation and easy placement, as well as remodeling, patency, and integration on the long term, SAG will revolutionize the scenario of hemodialysis vascular accesses worldwide by: reducing the frequency of complications and re-interventions (thus health costs); granting broader access to hemodialysis; improving the patients’ quality of life, enabling them to live longer as functioning members of the society. SAG has reached TRL 6. Phase 1 would allow BEL to verify the soundness of SAG’s venture (with a Business Plan and an IP Management Plan), and to de-risk the technological viability of the industrialization (delivering Essential Requirements, Risk Analysis, Validation Master Plan, Industrialization Plan), in view of future clinical studies, certification and commercialization. SAG represents for BEL an important opportunity to diversify its product portfolio, enter the market of Advanced Materials, experience growth in productivity and competitiveness and create new jobs. As the commercial potential of SAG is estimated to be around 28 million € in 2025 and 54M€ in 2030, in 2025 the SME would experience an increment in turnover of about 470%, and a 36% increase (from 28 FTEs to 38 FTEs) in highly skilled human resources.