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Neurological evaluation with simple tools to track evolution and perform early detection of neurodegenerative issues

Periodic Reporting for period 1 - MEMEMTUM (Neurological evaluation with simple tools to track evolution and perform early detection ofneurodegenerative issues)

Reporting period: 2015-04-01 to 2015-09-30

We have focused our efforts to analyze and validate several aspects of our product mememtum, business model and markets to:
1. Identify risks and ways to overcome them.
2. Identify additional opportunities based on our technology and current situation.
3. Validate the business model with different stakeholders.
4. Confirm the economic viability of the business.

mememtum is the first tool to provide a personalized neurological evaluation and early detection based on a solid scientific background. It is usable on smart-phones to provide wide access and lessen usability barriers.
FtO and IP Strategy
We have confirmed our Freedom to Operate state and our intellectual property protection strategy approach in conjunction with a external partner. In order to make mememtum an EU certified medical device we have analyzed Legal Regulations in the field of medical devices.
Product and Market | Competitors
New products, potential customers and markets segments have been identified based in our work in: European and global Markets Analysis and Competitors Report.
Meetings with Neurological Specialists, Hospitals, Pharmas and Insurers have been held to validate and improve the product and business approach of mememtum.
mememtum have been used also in a Medical Study in Ecuador with 700 patients supervised by our scientific team.
Business Model Validation
Based on the previous market analysis and product definition we have approach to companies in several categories:
Patients Associations: Fine tune product focus and establish alliances. Diffusion and awareness campaigns.
Hospitals: To start joint team to create pilots and generate papers and support to the different tests under a scientific and medical point of view.
Pharma: To gather information and add interesting product features and business validation for mememtum to increase value in the drug-to-market pipeline.
Insurance Companies and Prevention Entities. Business validation and analyze real interest.
Health Providers: To establish agreements using their currently established channels to Public and Private Health Systems in Europe.

mememtum covers several market and user needs being the main one the lack of accurate and objective tools to analyze patients (Parkinson's Alzheimer's) even when the disease hasn't been detected or diagnosed.
mememtum can be addressed to the whole population as a tool to evaluate the user general neurological condition.
We see a clear differentiation between mememtum and it's potential competitors.
There is a clear interest in key Entities related to health and care giving services.
Scientific and Medical Validation:
We have based our validation on the analysis of data from our current database with 500 patients and control subjects and in the resulting data from a new study developed in Ecuador within the National Prometeo Program:
This work has been done in The Strategic National Plan of Neurodegenerative diseases of the Ecuador Republic inside the PROMETEO program.

The Prometeo Project is an initiative of the Ecuadorian government that seeks to strengthen research, academy, and knowledge transference in specialized topics through the incorporation of foreign and Ecuadorian experts (who live abroad) to different host institutions. It is aimed at universities, polytechnic schools, public research institutes, and other public or co-financed institutions that require assistance in the development of research projects in areas of priority. The time of incorporation of the Prometeos may be from 2 months to one year (not necessarily in consecutive periods), during which they will develop a joint project with their host institution that will contribute in areas such as: life sciences, natural resources, innovation, production, social sciences, education, art, and culture.

Two of the main Scientifics in the mememtum's team - Justo García de Yébenes and María Ángeles Mena - have designed and lead an ambitious project to test several hypotheses related to Parkinson's disease working with the team composed by Lissette Lalvay, nursery specialist; Andrea Mora and Miguel Lara, physicians and Fernando Alarcón, manager of the neurological department of Eugenio Espejo Hospital.

This project consists on the analysis of simple and more complex hand movements using the tactile screen of a smartphone to gather information on number of taps, fatigue and regularity on patients with idiopathic Parkinson's (EP), vascular Parkinson's (EPV), their sons and daughters, healthy subjects and other essential tremor patients.

Scientific data support to our main hypothesis: the use of specific test to measure motor symptoms can be used to evaluate the state of neurological patients and to detect early premotor symptoms.

Improvements on tests and tools have also been identified and incorporated to the Tool Improvement and Development Work Package.
~ Two on-going scientific papers to be soon published in Q1 2016.
~ A specific set of improvements in the current tests and new ones to enhance the neurological evaluation accuracy incorporated to the mememtum 3.0 product management document.
~ Usability improvements from both patients and medical professionals incorporated to the mememtum 3.0 product management document.

Product usability:
Workshops and interviews with:
- Neurologists
- Patients
- Pharmaceutical Companies
- Care givers

...have been held to identify improvements on the product and new features.
A specific study to validate all the tests has been designed in collaboration with one of the main neurological hospitals in Spain.

We have identified a product validation company with large experience in testing health devices and software in real environment located in The Netherlands.

~ Product improvement and usability report incorporated to the mememtum 3.0 product management document.
~ Key features for market agents incorporated to the mememtum 3.0 product management document.

Business Model Validation:
Several sessions and specific workshops have been held with the business team - Taniwa staff, EU Commission Coach, consulting partners - to identify product and markets based on our technology.

Competitors analysis has helped us to identify the unique value proposal of mememtum and how to address it to the appropriate market and customers.

We have based our conclusions on the Business Plan model using KPIs (Key Performance Indicators) such as Return of Investment, EBITDA and scalability of the solution.

Health market has been analyzed in both vertical and horizontal fields: Territorial, markets, public and private sector.

Finally face-to-face meetings have been maintained with decision takers of the main companies related to the business model of our product seeking for: Validation and/or partnership with fruitful results.

Viability of the commercial proposal:

Different approaches have taken place in this area: one of them identifying risks and barriers to overcome, and on the other hand testing the commercial viability and scalability of the final product(s).

In the first area we have work together with a Intellectual Property and Patents consulting firm to study the state of the art and the patents scenario in the neurological analysis field. A Freedom to Operate analysis and a IP Protection Director Plan with specific action we have already started to accomplish.

In the same direction we have analysed the Spanish and European regulation about medical devices and the procedures and practices to follow. We have designed a Certification Plan and identified a consulting specialist to hire during the process.

In several internal workshops we have identified 3 different products derived from our technology and 4 different markets to address. Interviews and business model validation have been the base of our process, stressing the models to choose the best combination based on:
Value added and opportunities.
Market size and scalability.
Counting on the best partners and channel to customers.

As a summary: data is the key for our product and business model

We see the process of selecting partners as a key aspect of our success.

After several iterations and a large set of meeting and approaches, we have succeeded in finding partners in the following areas:
~ Patients Associations. Focus and usability validation.
~ Scientific/Neurologists: Solid scientific background.
~ Care Centres: Users and elderly tests.
~ Hospitals: Clinical and business plan (part A)validation.
~ Health Technical and Software suppliers: Channel to reach health systems and hospitals.
~ Insurance Companies: Channel to preventive business model.
~ Pharma: Get directives and features for product and data mining interests. Customers.
After the required development and business work the main results are:
- The first tool for Neurological evaluation based on simple test with solid scientific support.
- Prediction test system for regular population.
- A validated business model with: Pharma, Hospitals and Insurance Companies.

Mememtum, also has a deep impact in medical public and private health systems:
- Helping Health systems to improve their service to end users while saving costs.
- Helping patients, relatives and caregivers to improve quality of health/life saving indirect costs.
- Opening new ways to care and be cared.

10.000 €/year is the average cost in Europe for a Parkinson's for Alzheimer's patient.
We claim to save at least a 3% of those costs from the savings in time, commutings and diagnose procedure improvements.
There are more than 15 million patients living with Alzheimer's or Parkinson's.
With mememtum we can save more that 250 Millions each year as a collateral benefit to the European society.