Infertility impacts 25 million European citizens and 90 million couples globally (1 in 6 couples). Europe’s total fertility rate is among the lowest in the world, at 1.5 children per woman, a figure that is expected to decrease further to 1.2 by 2030 – making it a critical public health issue.Typically, infertility is treated with intrauterine insemination (IUI) or IVF. IUI is the most common first-line treatment as it is non-invasive and relatively cheap, but its success rate of around 7% means that IVF, a far more expensive and invasive procedure, with an overall success rate of around 30% becomes necessary. The market needs an affordable, easily accessible, non-invasive alternative that increases the success rate.EVIE 2.0 is a patent protected, fully automatic slow release insemination device that bypasses the hostile cervix to slowly release sperm into the uterus over four hours via a proprietary balloon catheter and an insemination syringe. Unlike standard Intrauterine Insemination (IUI), EVIE mimics nature by slowly and gently releasing the sperm - maximizing the opportunity for the sperm to reach the egg and increasing the prospect of fertilization - more than doubling the success rate of 7.2% to 18.7% and decreasing the average cost per pregnancy. EVIE 2.0 will transform the infertility market by providing an alternative non-invasive first-line treatment solution withincreased success rate, reducing the need for couples to resort to expensive and complex treatments. To have EVIE 2.0 fully projected at a European and global level we need a further investment of €2.5M to complete all product development, scale-up and complete a clinical study. The proposed work in Phase 1 of the SME instrument fits into our overall plan to reach the market by contributing the financial resources needed to plan a fast, sound and widee deployment of EVIE 2.0.