A slow release insemination that doubles the success rate of the most common first line treatment of infertility.

Project Information

EVIE 2.0

Grant agreement ID: 882909

DOI

10.3030/882909

Project closed

EC signature date 13 November 2019

Start date 1 December 2019

End date 29 February 2020

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

FERTILIGENT LTD
Israel

Periodic Reporting for period 1 - EVIE 2.0 (A slow release insemination that doubles the success rate of the most common first line treatment of infertility.)

Reporting period: 2019-12-01 to 2020-02-29

Summary of the context and overall objectives of the project

Infertility is a reproductive disorder defined by the failure to achieve a clinical pregnancy after ≥12 months of regular unprotected sexual intercourse. It affects 25 million European citizens and 1 in 6 couples globally. Europe’s declining fertility rate, currently at 1.5 children per woman, is among the lowest in the world and is expected to decrease to 1.2 by 2030 – making it a key public health issue in the region. Treatment is dependent on diagnosis: the more complex the reasons for infertility, the more complex the procedure. As the least complex option, intrauterine insemination (IUI) is the standard first-line fertility treatment most frequently used worldwide, especially for unexplained infertility, mild male sub-fertility, cervical mucus problems, erectile dysfunction, vaginismus, retrograde ejaculation and same sex couples. Most doctors recommend up to six IUI attempts before progressing to IVF in applicable cases. Although IUI is an attractive option because it is a minimally invasive, low risk and affordable, typically costing €500-€1000 per procedure (without drug therapy – this price can actually increase to €3000 when one includes medication, monitoring, bloodwork and insemination ), it has a low success rate of 6-12%. Unlike natural insemination, IUI relies upon a sudden deposit of highly concentrated processed sperm into the uterine cavity (bolus), decreasing the window of opportunity for ovum fertilization.
The low success rate of IUI often leads to the early use of high risk, expensive IVF treatment. IVF is a complex, highly invasive procedure involving drug therapy (with possible adverse side-affects) to induce ovulation and close monitoring which help to boost its success rate to 32.2%. Risk factors include ovarian hyperstimulation syndrome, ectopic pregnancy, multiple births, premature delivery and low birth weight. Women undergoing IVF treatment also run a fourfold risk of developing borderline ovarian cancer.
At Fertiligent, we wanted to explore the possibility of developing a first-line infertility solution as safe as IUI but with the success rate of IVF. Muharib, Gadir & Shaw demonstrated that slow release insemination (SRI) is an advanced alternative to regular Intrauterine insemination (IUI) by more than doubling the success rates. This study led to the concept and development of EVIE, our wearable/portable low cost, successful first-line treatment to infertility.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The project highlighted the Fertiligent technology’s substantial potential owing to its ability to double the success rate of IUI at a similar cost, avoiding the need for invasive and costly ART procedures such as IVF. Moreover, the technology’s applicability in other medical areas shows the scalability of the technology. During the assessment, we developed a product growth plan to reduce the complexity of the first-generation device and to introduce a novel balloon catheter that releases sperm close to the fallopian tubes' orifice to further increase the success rate. Beyond this, we outlined our clinical pathway that includes two 100 patient single-center randomized cross-over studies. The first trial enables us to gather data on the impact, efficacy and safety of the slow release syringe actuator. The second study will provide data on the impact of the near fallopian tube insemination as it includes clinically testing our novel split balloon catheter.
The financial feasibility review showed a forecast of generating revenues of €74.3 million by 2027 and a net profit of €22.7 million. It showed we would have a positive cash flow from 2025, the year in which we will expand to the US market. The ROI based on the cost of our next innovation project is 11.3 based on cumulative profit. It also revealed the need to increase the team by 67 new employees, with growth in management, sales, R&D and administration required.
The commercial feasibility highlighted the importance of the European and US market. The rising infertility rates in both regions and patients being more receptive to artificial insemination technologies means they are the two largest artificial insemination markets. We completed a top down analysis using IUI cycles as a way of identifying our addressable market in these regions. We discovered the potential IUI caseload in the EU to be 2.92 million in the EU and 2.8 million in the US (totalling 5.72 million annually). Owing to its superiority over standard IUI treatment at very similar cost, EVIE 2.0 will disrupt this caseload and capture a growing percentage of the procedure across both regions. We will begin commercialization in Europe in 2023. We will work with infertility medical device specialist distributors to reach our customers, Fertility clinics. We will initially focus on finding distribution networks in the top five countries in Europe by ART volume - UK, Germany, France, Italy and Spain.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Fertility treatment is highly dependent on the causes of infertility, but in most cases IUI is the first-line treatment due to the lack of complexity. Patients are often referred for in-clinic intrauterine (IUI) procedures combined with fertility drugs and/or HCG in the interests of getting the best possible outcome. Nevertheless, its low success rate (~7%) has resulted in infertile couples increasingly being referred for a highly complex and invasive IVF procedure earlier than necessary to obtain successful pregnancy.
The EVIE 2.0 device will become the first-line fertility treatment of choice as it is as easy to use, affordable and more than doubles the pregnancy success rate of IUI. Crucially, that success is attributed in large part to increasing the number of sperm reaching the fallopian tubes, something we have further incorporated into the EVIE 2.0’s design. The low cost and increased success rate position EVIE uniquely in the market as the most cost-effective infertility solution : the cost per pregnancy almost halved, just €5300 compared to €11,300 (IUI), and roughly one quarter of the cost of IVF at €20,200. In addition, EVIE is non-invasive and uses 100% of the prepared sperm.

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