Periodic Reporting for period 1 - DIALYBRID (Revolutionising the world of hemodialysis with a novel, hybrid, silk fibroin/polyurethane vascular access)
Okres sprawozdawczy: 2018-12-01 do 2019-05-31
SAG (Silkothane® Arteriovenous Graft) is a novel, hybrid semi-degradable, nanostructured vascular access, manufactured by electrospinning using Silkothane®, a silk fibroin/polyurethane blend developed by Bioengineering Laboratories (BEL). SAG aims at revolutionizing the vascular access market providing early-cannulation possibilities as synthetic grafts, together with the remodeling capabilities of native fistulae. With DIALYBRID, BEL aimed at verifying the soundness of SAG’s business venture and at de-risking the technological viability of its industrialization, in view of future clinical studies, certification and commercialization.
A Risk Analysis, conducted according to ISO 14971, enabled the identification of hazards related to SAG’s manufacturing and use, the classification of events (causes) possibly leading to them, and the association of a degree of harm severity for the patient. Risk control measures were defined in order to lower the probability of occurrence of these events, in a way that each and all of the risks become acceptable in light of the benefit brought by SAG to the patient.
The elaboration of a Biological Evaluation Plan according to ISO 10993-1 highlighted the need of the product chemical characterization (ISO 10993-18) as a prerequisite information needed to support biological safety assessments. SAG’s characterization will need to be deepened in terms of extractables and leachables, process residues and degradation products.
An Industrialization Plan was elaborated, addressing challenges related to raw materials (mainly silk fibroin and polyurethane) as well as to the manufacturing technique (electrospinning).
Also, strategic IP Management actions were carried out during the project, including the enrichment of SAG-related patent portfolio and a Freedom to Operate analysis, the latter highlighting a crowded IP landscape, but moderate to low risk of infringement within the major markets (EU and USA).
Finally, the Business Plan was refined, encompassing all the phases of product industrialization, validation and certification, as well as strategic partnerships for commercialization.
The elaboration of a Biological Evaluation Plan according to ISO 10993-1 highlighted the need of the product chemical characterization (ISO 10993-18) as a prerequisite information needed to support biological safety assessments. SAG’s characterization will need to be deepened in terms of extractables and leachables, process residues and degradation products.
An Industrialization Plan was elaborated, addressing challenges related to raw materials (mainly silk fibroin and polyurethane) as well as to the manufacturing technique (electrospinning).
Also, strategic IP Management actions were carried out during the project, including the enrichment of SAG-related patent portfolio and a Freedom to Operate analysis, the latter highlighting a crowded IP landscape, but moderate to low risk of infringement within the major markets (EU and USA).
Finally, the Business Plan was refined, encompassing all the phases of product industrialization, validation and certification, as well as strategic partnerships for commercialization.
Overall, DIALYBRID contributed to confirm the feasibility of SAG’s industrialization and commercialization, proving its commercial potential (around 28 million € in 2026 and 54M€ in 2031) and corroborating the forecast positive impact on BEL’s growth in terms of productivity (+470% turnover) and competitiveness (+50% qualified FTEs).