Advanced Sterilization Capability with Low Environmental footprint for Patient Infection Optimized Safety

ended

MedTech industry is facing the emergence of innovative single-use and reusable medical devices [MD] with ever more complex forms and sensitive components in needs of optimal safety conditions of sterilization. However, hospitals face problems with chemicals, radiation, and limited sterilization options, leading to compromises in patient safety and potential device contamination [over 20% of endoscopes are tainted]. Similarly, MD manufacturers encounter technological, environmental and health obstacles, which can limit production capacity and endanger patients' lives. Regulatory and political pressures are growing to eliminate the use of ethylene oxide (EtO), and current technologies face challenges in capacity and compatibility with MD materials, reducing the resilience of production of MDs. In this context, AURORA has developed the first In Situ Cold [non-Thermal] Plasma Sterilization technology for MD that turns air gases into a plasma and doesn’t use any chemicals, radiations, nor leave any potentially harmful residue. This breakthrough process, able to destroy all biothreats, is designed to answer the needs of both hospitals and MD manufacturers in better safety standard for patient and staff, and environmental protection. ASCLEPIOS will materialize 12 years of R&D programs which aimed at validating the feasibility of its cold-plasma sterilization process and developing its efficacy on the full range of biothreats [spore, viruses, bacteria, biofilms] and while remaining compatible with fragile MDs, representing key assets towards unlocking early technical and economic barriers to commercial exploitation. While TRL6 has been successfully passed, the herein ASCLEPIOS proposal will allow reaching TRL9. This last step allows the technology to be deployed Europe- and US-wide, creating a strong economic activity, replacing current solutions and thus meeting social, health and environmental challenges and establishing a strong European leadership in this new field.