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EMBRYON - Develop and commercialize a highly innovative diagnostic-imaging product, improving success rates in the Assisted Reproduction IVF sector

Periodic Reporting for period 1 - EMBRYON (EMBRYON - Develop and commercialize a highly innovative diagnostic-imaging product, improving success rates in the Assisted Reproduction IVF sector)

Reporting period: 2015-03-01 to 2015-08-31

Infertility is a heavy social issue, experienced by nearly one in six couples during reproductive lifetime.
In Vitro Fertilization (IVF) is growing 8-10% p.a.,to 1.5 million therapy cycles and 7.5 billion dollars in 2013.
Despite stressful and costly procedures, IVF success rate is low (15-20% births vs cycles), leaving big opportunities for innovation and process optimization.
EMBRYON introduces to IVF clinics and specialists a last-generation diagnostic-imaging system, favouring better outcomes through deeper, smarter analysis of clinical images.
It merges tailored image-processing software and algorithms, patented by ACS, with a high-end commercial IVF microscope. A prototype is under validation, supported by a manufacturer of IVF microscopes.
EMBRYON improves the key success factor of any IVF procedure: the identification of 1-2 zygotes with best “pregnancy potential” to be transferred in utero, amongst 5-10 generated in vitro.
EMBRYON’s precision is double than current handcrafted approaches, favouring higher success rates.
It is safer (100% not invasive),thus simpler to certify and adopt, fully compliant with ethical regulation, easier to use (no change to lab procedures) and cheaper than similar products.
Key innovations
1. Automated deep scan of embryo shape,overcoming today’s subjective and approximate observations carried by the physician
2. Proprietary algorithms for the measurement of complex morphological patterns,strong predictors of potential
Sales forecasts are 1200-1400 units (40-45 M€ gross revenues) by 2020 in Europe and US,favored by:
- High reactivity of the IVF sector (scientists / patients) to validated solutions improving outcomes
- Commercial partnership with a global IVF microscopy leader

Objectives of the action are:
1) Fine tuning and final validation of EMBRYON algorithms and their clinical effectiveness
2) Finalization and user-validation of the overall EMBRYON system and its end-to-end use case (microscope + SW user interface + algorithms). Main focus on usability, robustness, reliability and stability of outcomes.
3) Elaboration of a comprehensive business plan, with initial focus on EU and US markets.
During the Phase 1 project, we have carried out activities that can be classified according to 2 categories:
a. Technical and experimental activities to reinforce the confidence in the proposed approach
b. Market analysis and evaluation of commercial perspectives.

The experimental activities carried out during this period indicate the way to proceed on the technical and operational side.
The results, though based on a small dataset, (due to time and complexity of IVF cycles) clearly demonstrate the correlation of our method to embryos quality.
We compared our results with the most used method, the so-called Z-Grading, that is a visual classification of zygotes.
From a technological point of view, after having carried out a campaign using our algorithm as a retrospective diagnostic method, we can summarise the results as follows:

1. The EMBRYON concept is valid and correlates to pregnancy results obtained in IVF
2. The combination “LZPTV + Z-Grading” obtains the best results, increasing significantly the probability of success with respect to the use of the single methods
3. The definitive assessment of EMBRYON value can only be achieved by using it as a prospective method, i.e. using the LZPTV to select the best zygotes before they are transferred. This will allow the comparison of success rate with EMBRYON and the one without.
4. IVF procedures vary in Europe (and in the world) according to local regulations and specific medical practices. It would thus be useful to validate our concept in different operational situations, for example with different stage of evolution of zygotes, with frozen or fresh zygotes, etc.
5. There is the need to increase drastically the number of cases in order to reach a higher level of scientific confidence and to define the best configuration of the tool.

The market analysis allowed us to assess the significant potential of the market and the concrete possibility to enter successfully this market.
The global In Vitro Fertilization market is growing at high pace, promising high return on investment. The IVF global market growth has been estimated to increase with a CAGR rate of 11,6%, reaching $21,6 billion in 2020.
The proposed system does not have direct competitors since it is not alternative to time-lapse image analysis (that anyway is not always applicablle).
We carried out a SWOT analysis that helps us clarify the main elements that can influence the future development of EMBRYON.
Some guidelines of the marketing strategy have been developed, together with price policies, sales strategy and IPR protection.
Promotion actions toward scientific environment, clinical actors and end-users have been identified.
The adoption of our solution will have several advantages for IVF centres: more patients, better reputation and performance statistics, reduction of treatment time and effort.
More than 3500 IVF centers are active in Europe, carrying out 55% of treatments worldwide.
Around 1.5 million ART cycles are performed each year worldwide, with an estimated 350,000 babies born.
The cost of a single IVF cycle ranges between 8.000 to 25.000 EUR, depending on complexity and number of additional treatments. The annual growth rate of treatments has been 5% to 10% in the last years and the rate is expected to remain at these levels at mid-term.

The full deployment of EMBRYON will imply:
- higher success rates in ART treatments
- less cycles, that implies less expenses for couples
- less stress for couples, in particular for women undergoing ART treatments
- better use of public money in the countries that support ART.