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Accessible, Reliable and Simple Screening of stress- and memory-related diseases

Periodic Reporting for period 1 - ARSS (Accessible, Reliable and Simple Screening of stress- and memory-related diseases)

Reporting period: 2018-12-01 to 2019-03-31

European healthcare systems are today faced with new challenges regarding neurocognitive diseases. The elderly population is growing and people aged over 60 will increase by approximately 2 million people per annum in the coming decades expected to represent around 30 percent of the total European population in year 2060. Given the prevalence of dementia, Alzheimer´s and other cognitive impairments in the elderly population (50% of 90-year-olds have some sort of dementia diagnosis and from age 65, the risk of getting dementia doubles every five years), neurocognitive diseases will in the future pose one of Europe´s major public health challenges.

Both mental illness and age-related diseases result in mild cognitive impairment (MCI) e.g. memory loss and poor work-state memory and although MCI can be temporary as is the case with patients suffering from Depression, MCI can also be symptoms of a serious neurocognitive disease such as Dementia, Alzheimer´s or Burnout. As many chronic diseases can present cognitive dysfunction symptomatology, depending on the severity of each case, an accurate assessment/monitoring of the individual’s cognitive state is key as it can provide important information about the patient’s need and help to adjust pharmaceutical or behavioral intervention. Surveying/monitoring cognitive profile can provide clinicians with data about individual’s cognitive fluctuations in different circumstances (possibly explained by other collateral factors such as stress, sleep or hormones). Moreover, many interventions have a much higher success-rate if utilized before the disease has progressed.

Despite the need for early assessment, neurocognitive tests are used too seldom and too late in the healthcare chain, mainly due to screening tools being expensive and time-consuming as they require specialists for administering, analysis and evaluation. As general practitioner physicians (GP:s) do not have the resources or time to cognitively screen patients, a patient needs to be referred to hospitals and specialist clinics to be assessed. Since little screening is done prior to a referral, many patients are referred and consequently there is a long waiting list before seeing a specialist - during which the disease develops and progress to a stage where they are difficult, more expensive and less successful to treat. For example, in Sweden there is an under-diagnostization amongst elderly of neurocognitive dysfunctions and 50% of patients with dementia are not receiving the right dementia diagnosis.

Furthermore, new research is progressing to a stage where a pharmaceutical therapy that can treat or delay early-stage dementia patients is likely to be on the European market as soon as 2020. As new methods for treatment requires the disease to be in an early stage, the European healthcare systems will be posed with the challenge to move away from mitigating symptoms of dementia to allow for early screening and treatment of the disease. At the same time, research shows that long waiting-lists for neurocognitive screening may result in over a million patients with MCI progressing into dementia between 2020 and 2044 in six European countries.

The goal of the project (phase 1 and 2) is to bring the Minnemera concept to international market launch and move the TRL level from 6 to 9. The goal of phase 1 has been to investigate the technical, economic and financial feasibility of the innovation and get commitment from test partners for phase 2.
Task 1.Market analysis
We have studies and characterized the European market to further understand risks and opportunities. We have listed potential clients on targeted geographical markets (to visit in phase 2). We have elaborated a communication strategy and communication plans for targeted audiences to use in phase 2.

Task 2.Preparing the prototype
We have continued the development of the prototype preparing for user trials in phase 2. We have obtained CE-marking of the product and defined the technical roadmap. The technical roadmap details the features to be further developed, timing and budget for phase 2. We have secured the commitment of test partners in phase 2 and obtained further proofs of demand for our product.

Task 3.Freedom to operate and IPR strategy
Based on the freedom to operate analysis and the conclusions of the previous task, we have defined the most suitable IP protection strategy.

Task 4 Business plan
We have updated the business plan based the results from the feasibility study. We have concluded we have feasibility to continue the innovation process.

Task 5. Project management and financial plan
Based on results from all previous tasks, we have developed a comprehensive and elaborated financial plan that addresses the funding requirements as well as the financial forecast for the first five years after the market entry of Mindmore.
Our present situation is that we have some sales to primary care, not much, but we are commercial with our first version. The business idea has been a clarified in the way that we now have a first focus on primary care to get started and after that specialist care (secondary care). To avoid burdening specialist care, screening must be done within primary care where the high volume of patients come first. We need to send the right persons to secondary care. Today patients are found too late because they are not screened (e.g. for Alzheimer or burnout). They have clinical symptoms. 50% of the people who come to specialist care receive a subjective cognitive impairment diagnosis.

Mindmore is disease-based and we have now included several diseases by our tests. We have talked to representatives for the health care system, and they want to minimize the time the patient makes tests. The tests have to test the right thing. Patients should only use the right module, to save time. Therefore, we have chosen to be disease-separated. Diseases where we see a great need is dementia, stress and burnout. Our first priority is dementia. If you find the sick too late, you cannot stop the process (you cannot reverse the dementia). In Europe alone, 2 million nurses are needed to cope with all dementia diseases. Once fully developed Mindmore should be like a one-stop-shop for several diagnosis to be used in primary care. In primary care we will provide screening and diagnosis. For secondary care we will also provide support for treatment.

The strategic vision has been reinforced through the various performed actions and tasks in the SME Instrument Phase 1. Our long-term aim is to become the market leader when it comes to digital cognitive testing. Our vision is to prevent all cognitive impairments that actually can be taken care for. What gives us legitimacy to drive this change is mainly three things:
1) Our combination of profound knowledge in neuropsychology and technology.
2) Our starting point in evidence-based research and our close cooperation with healthcare.
3) Caregiver's burning need for effective tools for cognitive screening - a deficiency that we have
seen with your own eyes.

The ARSS project will have a substantial impact in Mindmore AB’s performance. By the end of 2023, we expect to increase our customer portfolio to around 2017 clients across the EU, €7 771 182 in turnover and 48 new jobs have been created. Considering the initial investment budgeted for Phase 2, the payback time will arrive by the 2024 with an accumulated profit of €4 812 804 by the end of that year. The first year with a profit will be in 2023 (€2 455 509). Compared to the growth analysis made in the phase 1 application we can grow faster and better. By 2025 we forecast to employ 57 people, generate over € 30 Million in turnover and generate a high profit.
Picture of one of the digitalized tests of Mindmore