ECONOMIC, LEGAL AND IP FEASIBILITY STUDIES OF EXHEUS VITAL TEST

Project Information

EXHEUSVITAL

Grant agreement ID: 101113870

DOI

10.3030/101113870

Project closed

EC signature date 2 June 2023

Start date 1 July 2023

End date 31 December 2023

Funded under

• European innovation ecosystems

Total cost

No data

EU contribution

€ 75 000,00

Coordinated by

EXHEUS SL
Spain

Periodic Reporting for period 1 - EXHEUSVITAL (ECONOMIC, LEGAL AND IP FEASIBILITY STUDIES OF EXHEUS VITAL TEST)

Reporting period: 2023-07-01 to 2023-12-31

Summary of the context and overall objectives of the project

Beyond You (formerly Exheus) is a spinoff of IR Sant Pau and the Universitat Politècnica de Catalunya (UPC) created in June 2020. The company has developed a fast, effective and attractive software that helps Health Care Professionals (HCPs) to efficiently support patients with obesity in their weight loss goals. The software offers advantages such as:
1. The information provided together by the RNA sequencing and by the company Artificial Intelligence technology allows to obtain precise information of the abnormalities in gene expression for each patient. This allow a high level of personalization that can’t be achieved with other methods to provide the best treatment for a given patient.
2. It allows to increase the adherence to the weight loss treatment increasing the effectiveness of the recommendations.
3. It helps HCPs motivate the patient and improve willingness to follow the health recommendations, therefore promoting a change in lifestyle habits sustainable over the time.
4. HCPs (i.e endocrinologist, primary care physicians) can now treat obesity through a clinically validated personalized medicine tool to guide and accompany the patient during its healthy weight loss process.
5. Monitoring the evolution of activated genes over time can be done through repeated tests to determine changes in these parameters.
In 2022 Beyond You started the commercialization of the software at a national level (Spain) following a B2B model, and in 2024-2025 the company expects to start their international consolidation and growing phase. The objective of this phase is to further grow the number of clients both nationally and internationally (Europe) to be a world leader in the sector.
Our product needs CE marking before being sold in the European Union, but we do not expect to obtain this certification until 2026. Therefore, we need to perform a feasibility study (economic, legal and protection) setting deadlines and priorities for implementing the commercialization strategy, validating the pricing strategy, and identifying the EU go-to-market countries. This will be carefully evaluated and planned with the help of Women TechEU grant, mentors and coaches.

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

As previously mentioned, the economic feasibility study is divided into 3 different parts: economic, legal and protection studies.
1. Economic feasibility
The study was divided in two parts, the first one being the market selection & secondary research and the second one being the primary research. This study was performed in collaboration with Arian International Project, a total number of 6 meetings (2hrs/each) to follow up the process and define criteria were hold. The activities performed and the results obtained are documented in a report.
In the initial phase of the market selection, we identified trustful data sources and established a set of filters (such as Health private expenditure, Human Development Index or population segmentation), to identify the world markets with the highest potential. After performing this part of the study, the data showed Switzerland as the most promising market to start the internationalization of Beyond You.
The secondary research started with a competitive landscape analysis, which provided us insight about our unique value proposition (UVP). Even though we identified some companies trying to solve similar issues, we did not observe any direct competitor working with the same technology as Beyond You. We finally divided the market into homogeneous groups based on their behaviour and needs. This step is vital for us, as we need to concentrate our resources on the market segments that most value our strengths.
For the primary research in the selected market, the proposition of Beyond You was evaluated via a survey. The activities performed in this part were the design of the interview and selection of interviewees, performing the interviews and processing the data obtained to elaborate the conclusions and final report.
2. Legal feasibility
The type of information Beyond You works with (mRNA) is considered sensitive personal data under EU General Data Protection Regulation. Therefore, we have designed a GDPR compliance plan to prevent data breaches and make our databases more resilient. We also studied how other regulations affect our product. We also assessed the regulatory strategy of Beyond You.
3. IP feasibility
During the project duration we have worked with UNGRIA to prepare a report on patentability in respect of a “METHOD FOR THE DETECTION OF DIFFERENTIAL PATHWAY EXPRESSION”, in which we determined the Freedom to Operate (FTO), the novelty and the inventive step of our technology.

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 economic feasibility study identified Switzerland as the best go-to-market, based on the data extracted from trusty databases. It showed that the healthcare landscape of Switzerland is similar to the one in Spain, so we could operate there while we do not have the CE marking. However, one of the main findings of this study is that healthcare professionals do not understand our technology (based on gene expression analysis) even if they are very interested in it. This is a barrier which we need to overcome, but it is no like it has not happened before. 10 years ago, the first microbiome tests came out and healthcare professionals did not understand them. However, now there are numerous microbiome tests in the market with commercial success. Therefore, we have found that for the internationalization to be successful we need to divulge about the technology and present validating studies. Moreover, we will use the knowledge obtained to work on the regulatory roadmap of the software and preparing a clinical trial.
The legal and IP feasibility studies showed that the market access is possible, and commercialization too. Therefore, the internationalization without the CE marking is possible.
To sum up, the project provided useful insights for the internationalization process. We focused the study in Europe, designing a GDPR compliance according to the legislation and developing an IP protection strategy. After looking at key indicators of European countries (such as the health private expenditure, human development index, segmentation of the population, etc) we decided to study the case of Switzerland. The survey performed in the primary market study showed similar results to the ones in Spain: there is interest, but the majority of people do not understand the gene expression analysis technology.