Community Research and Development Information Service - CORDIS

Periodic Reporting for period 1 - SEMENIZER (Feasibility study of a fully automated, integrated and standardized computer aided semen analyzer system)

Reporting period: 2016-08-01 to 2017-01-31

Summary of the context and overall objectives of the project

One of the heavy social problems related to industialization and changes of life is the Infertility. In industrial countries, the incidence of infertility has been increasing from 8% to 30% from 1960 to nowadays. Thus, decreasing infertility rate is a top priority for the World Health Organization (WHO). Half of the infertility cases are of a man side, associated to sperm quality problems.
Moreover, the low birth rate in the European countries is one of the most important problems in the European health sector. This new tool will allow a better understanding about infertility reasons, as well as a standardization of the research results, following the WHO standards. Our system will also make possible that over 60% of unexplained infertility cases will receive a precise diagnosis, and thus, the right therapy. The overall objective of our project is to draw the feasibility study of a disruptive product: a fully automated, integrated and standardized computer aided CASA system which will completely change the market commercial strategy rules. The novelty of our innovation project is two-fold and consists in: a) allowing to determine many infertility causes that have been unknown until now and b) many new users will benefit from our system being an user friendly, fully automated and integrated equipment. Our innovation will allow to widespread the use of this new technology in order to make semen analyses a routine and cheap test, changing the rules of the market.

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

In order to achieve these objectives, MICROPTIC has carried out a feasibility study (supported by EC through SME instrument ph1.) in the period August 2016-January 2017. The work performed in the Project is based on three pìllars: a) Market and customer study; b) Technical and regulatory assesment; and c) Economical and Financial study. Each pillar was developed following the aspects described below, which we considered necessary to define the best commercialization strategy for our innovation, so far.

Market and customer study

A complete market study has been performed where the most interesting markets for our system have been detected and deeply analysed for its better understanding. A route map for the entry to each market has been drawn.

Technical Study and Regulatory standards assesment

• Technical aspects: Comparison sutdy between manual, convencional and automated system semen analysis results. A new prototype design adapted to fullfil the clients needs and to WHO standards
• Certifications-:A Mapping of the required certifications for the Medical devices field as well a routemap of the actions to be done to get these certifications.
• IPR issues: An exhaustive IPR feasibility study was performed in cooperation with a higly specialised company in patent and brands. This study includes IPR strategy, freedom operate and component exclusivity.

Economic and Financial Analysis

– P&L projection (5years), Business scenarios have been estimated

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)

The Project addresses to a global market conformed by fertility specialists. The most important contribution of our project should be the delivery of fully automated semen analyzer. Semen analyze is both, an expensive and time consuming process, which involves obtaining samples, analyzing them to final reporting. Infertility specialist across the world are exploring ways to improve productivity with smaller budgets, against the backdrop of declining government reimbursement rates for laboratory testing, cost-cutting measures adopted by managed care organizations, and the general emphasis on reducing healthcare costs. Automation has therefore emerged as key need towards achieving cost efficiencies and enhanced productivity. Automation in laboratories involves replacement of manual, error-prone techniques with automated processes that involve minimal operator intervention.

The need to improve workflow against a backdrop of increasing number of diagnostic tests being performed is additionally driving the business case for clinical automation. With our system the time invested in a semen analyze is drastically reduced being this fact critical for a higher productivity improvement and for the increase of the benefits. Moreover, standardization is a real need for research centers and institutions as it helps to bring research results to the market as it has already been explained that SEMENIZER will be the unique and definitive solution to accomplish WHO standards in the semen research field.

Our system will solve different problems related to high cost, standarization, increase of the unexplained infertility cases and subjectivity of the results, being the only fully automated and standardized computer - aided CASA system in the market capable to measure a wide range of sperm characteristics objectively, qualitatively and quantitatively. Our system will represent a powerful tool for infertility specialists.

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