NON INVASIVE DIAGNOSTIC TEST SERVICE FOR “NON ALCOHOLIC FATTY LIVER DISEASE” MANAGEMENT

Project Information

DeMILI

Grant agreement ID: 717419

DOI

10.3030/717419

Project closed

EC signature date 22 February 2016

Start date 1 March 2016

End date 31 August 2016

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

Talemnology S.L.
Spain

Periodic Reporting for period 1 - DeMILI (NON INVASIVE DIAGNOSTIC TEST SERVICE FOR “NON ALCOHOLIC FATTY LIVER DISEASE”MANAGEMENT)

Reporting period: 2016-03-01 to 2016-08-31

Summary of the context and overall objectives of the project

Non Alcoholic Fatty Liver Disease (NAFLD) is a disorder affecting 1 out to every 3 people in developed countries, and growing; NAFLD comprises, from benign fatty liver (NAFL), to non-alcoholic steatohepatitis (NASH), this latter covering a wide spectrum of disease severity, including fibrosis, cirrhosis and hepatocellular carcinoma.

Talemnology proposes the use of a widely available medical image modality, the not enhanced MRI (Magnetic Resonance Imaging) for facing the lack of validated non-invasive methods for the NASH and Fibrosis diagnostics.

The proposed solution, DeMILI, is an on-line test service based on a web platform where doctors, from a liver MRI, can conduct a non-invasive test for NASH and Fibrosis diagnosing.

According the Work Plan included in the Phase 1 proposal, the work done has been focused on the following activities:

* In order to assess the technological/technical/practical viability:
- Regulatory requirements analysis
- IP strategy approach
- Initial “freedom to operate”

* In order to assess the economic viability:
- Market Study
- Payer/User and key stakeholder analysis
- Economic viability analysis
- Elaborated Business Plan

Through the actions performed has been possible:

- Conclude that DeMILI has “freedom to operate” to be commercialized in EU and USA.
- Establish the IP strategy for existing IP and the expected IP generated along the project.
- Identify the following steps in regulation process, the best regulatory path in EU and USA, the schedules and costs associated.
- A deeper assessment of market dimension and its potential which confirm the economic viability of the project.
- A better understanding of client´s needs, competitors, segments of customers, stakeholders, having immediate consequences in shaping our Business Model and in the design of the following clinical and technical validation.
- Develops and elaborated Business Plan.

In resume the outcome of Phase 1 is positive, evidencing that DeMILI is an innovation project with high potential in terms of Talemnology´s competitiveness and growth.

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

Our work along this Phase 1 has been divided between actions developed by the Talemnology´s management team directly, and subcontracted actions.

For the subcontracted actions the process has been the following:

1. Definition of the scope of the work to be subcontracted and definition of the deliverables.
2. Definition of the timing and conditions of each subcontracting.
3. Procurement process in order to ensure “best value for money”
4. Management of each action for control quality and mitigation of identified risks.
5. Analysis and validation of the deliverables for checking its accomplishment with the initial requirements defined and contracted.
6. Processing of the data contained in the deliverables in order to integrate the results and conclusions into the Feasibility Report and a Business Plan.

This has been a stepped process for the following tasks; Market Study, IP Strategy approach, Initial “freedom to operate”, Regulatory requirements analysis.

Typically, the steps 1 to 3 have been performed along the months M1 to M3 for all the actions, step 4 has been developed along the entire duration of the actions carried out by the subcontractors, and finally steps 5 and 6 has been performed along the months M5 and M6.

In parallel the Talemnology´s management team has developed directly the following tasks:

Pay/User and key stakeholder analysis and economic viability analysis; it both have been a continuous work along the M1 to M5 with the following steps:

1. Planning of the action.
2. Identification of the target profiles.
3. Development of tools for contacting.
4. Contacting process.
5. Results analysis.
6. Development of conclusions.

Finally, a processing work of all the data obtained through the subcontracted and self-performed activities, has been developed in order to give response to the required Final Report for this Phase 1; this action has been performed along months M5 and M6. All the information gathered has been poured in a Business Plan developed along the month M6.

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)

Thirty years ago, non-alcoholic fatty liver disease (NAFLD) did not even have a medical name, as physicians and researchers presumed the buildup of fat in the liver (steatosis) to be essentially benign. Currently there is a library of research documenting that NAFLD is a pathology that comprises from benign hepatic fat accumulation (simple steatosis), to non-alcoholic steatohepatitis (NASH), a progressive form that may lead to fibrosis, cirrhosis and hepatocellular carcinoma.

Recent analysis quantifies the enormity of the clinical and economic burden of NAFLD, which will likely increase as incidence of NAFLD continues to rise.

As example, in the USA, over 64 million people are projected to have NAFLD, with annual direct medical costs of about $103 billion [$1,613 per patient (PP)]. In EU-4 countries [Germany, France, Italy and United Kingdom], there are ∼52 million people with NAFLD with an annual cost of about €35 billion (from €354 to €1,163 PP). Costs are highest in patients aged 45-65. The burden is significantly higher when societal costs are included.

The management of this affected population is simply impossible to be carried out by means of an invasive diagnostic procedure as the liver biopsy, the actual gold standard, which has well-known inherent limitations, such as high costs, morbidity, and sampling error.

The market uptake of a no-invasive diagnostic method as DeMILI, has both, a clear socio-economic impact, plus a wider societal implication represented by its affordability and the global availability supported in its ON LINE operational model.

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