The Safe-and-Sustainable-by-Design approach for alternative metal-free wound dressings in NABIHEAL

GA n°101092269 1 This project has received funding from the European Union’s Horizon Europe research and innovation programme under grant agreement n°101092269. The Safe-and-Sustainable-by-Design approach for alternative metal-free wound dressings in NABIHEAL Mr. Andreas Falk CEO BioNanoNet Forschungsgesellschaft mbH GA n°101092269 2 The Nabiheal Project Some numbers & facts The SSbD Approach Targeted approach Results First findings Impact Economic, Environmental & Social 01 02 04 03 01 GA n°101092269 3 Nabiheal Project 01 Antimicrobial nanostructured biomaterial for complex wound healing GA n°101092269 4 Nabiheal Project Partners 01 5SMEs 4RTOs 4Universities 1Hospital GA n°101092269 5 Background & Needs and Solution 01 Complex wounds are a global health problem with significant impact on the health care economy. In developed countries alone, they impact the quality of life of more than 2% of total population. Complex wounds, including chronic wounds or major burns, are highly susceptible to microbial infection and biofilm formation, and difficult to treat. Moreover, silver is a widely used metal in antimicrobial products to treat wound infections. However, silverbased products are expensive, and show several drawbacks due to costs, as well as environmental and safety concerns. The four stages of the wound-healing process and corresponding time scale. (DOI:10.1007/s10787-023-01318-6) The NABIHEAL project will develop multifunctional biomaterials, from proof-of-concept (TRL 3) to the preclinical regulatory stage (TRL 5), to improve wound management. The resulting biomaterials will enable affordable treatment of wound infections or prevention of complications during all phases of the wound healing process. Stages of healing with NABIHEAL multifunctional biomaterials GA n°101092269 6 Nabiheal Work Plan 01 GA n°101092269 7 02 SSbD Approach Phases for the development of a nanomedical product and how to implement the SSbD approach. NABIHEAL understands sustainable development in its three dimensions: safety, environmental and socioeconomic. The methodology applied by the project advances scientific knowledge and innovation and upholds principles crucial for safe and sustainable biomedical research. By integrating SSbD principles throughout the whole innovation process, NABIHEAL contributes to the development for safer and more effective treatments while promoting environmental stewardship and socioeconomic integrity in the biomedical sciences. GA n°101092269 8 •Nabiheal’s tailored SSbD tiered and hierarchical approach and implementation follows the JRC SSbD framework •Tailored questionnaires on (i) materials used/produced and (ii) for production and manufacturing processes were developed and implemented at the start of the project and will be reviewed at different times during the project lifetime. Questionnaires builds on: 1) Early4AdMa & SUNSHINE projects 2) Laboratory visits 3) Bilateral meetings with all actors involved in the project •Special focus on nano-safety issues and regulatory aspects are addressed •Formulation of specific recommendations are provided •Comparison to standard-of-care wound care materials is provided 02 Methodology used GA n°101092269 9 03 Results - initial SSbD assessment from Step 1 Uncertainty for internal hazard was rather high for NABIHEAL components, but justified due the early project status. However, it should be noted that components are well characterized on a physicochemical level. Regarding human and environmental safety aspects NABIHEAL components were compared to the standard of care with the goal of ultimately surpassing them in scoring. ●Outcome Nabiheal components on a good way of catching up already with SoC ●Challenges Information availability for SoC (which components + info on components)