Periodic Reporting for period 1 - FLEXDYM (FLEXDYM, the material revolution for microfluidics) Período documentado: 2019-02-01 hasta 2019-10-31 Resumen del contexto y de los objetivos generales del proyecto Microfluidics is a disruptive technology for manipulation of fluids at microscale. Operating at this scale offers several advantages that can be leveraged in medical devices and as such, microfluidic tools can be envisioned as integrated laboratories. They contain channels with dimensions ranging from single to hundreds of microns that facilitate fluid sensing and reaction, whether it is biofluids (blood, urine, etc..) in a diagnostic device, flue gas for carbon capture, water for micropollutant removal. The gains from such confinement are immense: optimized reagent volumes, boosted reaction rates and higher sensitivity. Microfluidics can also operate from extreme low volume quantities (nanolitre and below) up to several hundred thousand when massively parallelized. Microfluidics are integral to many of the breakthrough technologies in the last decade and a half (liquid biopsy 2015 ; neurochips 2014 ; personalized medicine 2007)1. The overall market value of microfluidics for life sciences was $2.5B in 2017 and is forecasted to reach $5.8B by 2022 (compound annual growth rate (CAGR)2017-2022 :18%). Even more interesting, this multi-sectional technology can still be imported to other fluid-based segments (chemical synthesis, water depollution, fuel cells, …), meaning its ascension is expected to accelerate. To become the leader in microfluidic systems, Eden Microfluidics envisions a « factory of the future », with proprietary advanced materials for microfluidics, microfabrication machines and design services for its end-users. To enter the market, Eden benefits from an unique material, the first polymer specifically formulated for microfluidics: Flexdym. Eden Microfluidics has already established production and commercialisation of advanced polymers and microfabrication solutions for microfluidics, and now develops the first microfluidic water treatment solution. This solution removes or degrades micropollutants (pesticides, antibiotics, heavy metals, ..) from water in a compact, low-energy device, called AKVO. With AKVO, access to clean water can be achieved at all scale, without excessive energy use. The objective of this proposal is to establish the potential of this technology with technical feasibility studies and business market analysis. Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha BUSINESS FEASIBILITY OBJECTIVES AND OUTCOMES ➢ Scout and identify industrial partners in the value chain and stakeholders influencing the commercialisation success➢ Size the reachable market and a reliable market share: qualitative and quantitative results derived from comprehensive customer and market analysis. ➢ Establish a sound go-to-market strategy: interest for the business project and further cooperation of at least 2 large distributors secured. ➢ Prepare detailed 10-year financial projections. ➢ Establish next steps for effective IP management: potential patents and trademarks to be deposited; further PCT applications to be filed; extensions to other countries. ➢ Risk assessment & Contingency Plan: main risks identified, and appropriate mitigations planned. TECHNICAL FEASIBILITY OBJECTIVES AND OUTCOMES ➢ Plan a feasible product development: preliminary specifications defined, all technical activities needed to launch AKVO at a large scale identified. ➢ Plan microfluidic chips development, with the following identified: microfluidic developer company, microfluidic manufacturer, microfluidic chip to be developed, including number of chips required, and timeline needed to validate their suitability. ➢ Identify and plan for required manufacturing practice accreditations: Regulatory context of EC accreditations and CE mark established; other accreditations investigated. ➢ Establish a feasible preliminary industrialisation plan and elaborate the full business operations: all value chain actors identified; all manufacturing and distribution infrastructure identified. Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha) Advances and science to technology breakthrough: Eden Microfluidics (EM) has conceived a new microfluidic design for high-volume application by taking inspiration of natural processes like blood circulation in the lungs and kidneys, where an intricate channel architecture handle flow rates up to 2-6 L.min-1 (for humans) in microcapillaries. EM patented architecture includes a high-density microchannel structure present in a 12-cm CD-like microfluidic cartridge (the CD architecture is inherited from microfluidics’ parent field, microelectronics). A typical single CD architecture with thousands of channels, dimensions of 2000x300x10 µm3, delivers flow rates of 15 L/day at pressures of 1 bar while, for comparison, RO requires 7 bar. The platform is highly modular with the unit module consisting in a stack of CD-like cartridges, bonded together by hot embossing/injection molding, enabling lengthy fluidic networks inside the overall device on a minimal footprint. : A device with the size of a soda bottle can deliver up to 5 000 L/day. The modular stacked CD architecture adds versatility to the system allowing efficiency and flow scalability, easy module removal for maintenance and the possibility to form different fluidic circuits (with serial and paralleled module arrangements). The system works as follows: the water to be treated, after filtration for removing suspended solids, enters the system through the inlets. As it circulates through the microchannels with adsorbent molecules immobilized in its walls, water will progressively be depleted of its micropollutants content (adsorption cycle). Once the adsorbent is saturated with antibiotis (ABs) or endocrine disruptors(EDs), a regeneration cycle begins. The module will continuously perform adsorption-regeneration cycles with optimum cycle-times. Parallel modules are setup to ensure redundancy and maintain continuous operation during the regeneration cycle. The system will be created using the first thermoplastic polymer, specifically designed for microfluidic application, patented by Eden Microfluidics, Flexdym®. This polymer can be molded with methods compatible with mass production (unlike the more common PDMS), meaning that a prototype can be industrialised straightforwardly. This polymer is also low-cost, easy to mold, biocompatible and transparent. However, it has not been tested for water treatment application, and we will consider other materials (e.g poly(methyl methacrylate) (PMMA) or cyclo-olefin polymers (COP)).