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A point of care device to provide real-time blood analysis for chronic diseases.

Periodic Reporting for period 1 - spinitCompanion (A point of care device to provide real-time blood analysis for chronic diseases.)

Reporting period: 2016-12-01 to 2017-04-30

Chronic patients are heavy users of health resources. According to the European Commission, between 70% and 80% of national healthcare budgets are currently spent on treating chronic diseases and, of this expenditure, nearly 97% of resources are spent on treatment, while only 3% is invested in prevention. As a result, heart attacks, strokes, diabetes and cancer, cost EU economies as much as €115 billion or 0.8% of GDP annually, of which up to half of these treatment costs incurred could have been prevented through timely intervention. This figure does not include the additional loss in terms of lower employment rates and productivity of people living with chronic health problems. This is highly due to the absence of fast, effective, and readily on-demand solutions that pick up on incoming fall-out from chronic disease, so as to prevent them through timely intervention.
The Feasibility Study showed that spinitCompanion is viable technically and commercially, determining the business project to be a profitable investment. The main achievements reported in the study were:

1. The clear market demand for decentralised blood assessment tools that address key metric concerns of quality, speed-of-assessment, ease-of-use, accessibility, and affordability. Significant investment and research continues to be pumped into the various aspects of blood assessment solutions worldwide. These problems continue to persist for affected physicians and patients, and as a result, is far from satiating growing demand.

2. The quantification of production costs and the selection of components suppliers with a target price for each component, and the definition and involvement of pivotal organisations in the spinitCompanion value chain. This includes value chain members the proposed innovation project as well as commercialisation that includes: third-party in-kind contributor University IADE for assistance in user-experience interface development; third-party in-kind contributor Laboratório Joaquim Chaves based in Algés Portugal, in-charge of the clinical validation of the industrial spinitCompanion; service provider Mezao for development of custom prototype electronics; third-party in-kind contributor SELT carrying out scaled production of core electronic components Multi-Function-Boards (MFB), as well as sub-contractor Vangest for series 0 production of industrial device enclosures. The Phase 1 study ascertained Portugal, Spain, Netherlands and Italy as the natural commercial entry point considering existing distributors such as RevDiagnostics and AxonLab having established sales channels to initial commercialisation customer medical facilities, departments and clinics within these highlighted go-to EU states. Furthermore, Phase 1 allowed definition of the European regulations, and clinical pathways required, highlighting the safety and performance measures as key. biosurfit has clear indication on EU commercialisation requirements in the form of ISO 9001 and ISO 13485 for Quality Management Systems in production, and specifically involving medical devices; EN60601-1-2: 2007 EMC and IEC 60601-1:2006/AC: 2010 on Electrical Safety of the medical equipment; and IVD Directive 98/79/EC as a Class B Device to undergo ‘Full Quality Assurance’ under Annex VIII on clinical safety and performance; and the CE mark as an all-encompass verification for immediate commercial use in Europe.

3. The business plan for the European and international commercialization of spinitCompanion. This included the definition of a reliable market price and the selection of the primary market and tertiary markets based on immediately addressable demographics subscribing to the MVP specifications on clear quantification for diabetics and co-morbidity assessments, as well as existing CRP and blood count abilities made available in the existing Spinit product suite. Confirmation of medical customers through existing medical distributor channels. Distributors include RevDiagnostics, AxonLab, Bioservice, Point of Care Testing, MedXNordic, among others in the EU.

4. The definition of a workplan for the development of pre-commercial spinitCompanion units and for its conclusive demonstration with Laboratório Joaquim Chaves for purposes awareness dissemination and affixing of CE mark.
biosurfit solution responds to two main objectives outlined in the EC’s Health Policy and Europe 2020 For a Healthier EU, which cover both relevant economic and social aspects:

1) Improve the sustainability and efficiency of social and healthcare systems. According to the European Commission, between 70% and 80% of national healthcare budgets are currently spent on treating chronic diseases and, of this expenditure, nearly 97% of resources are spent on treatment, while only 3% is invested in prevention. These are in line with the EC’s Major and Chronic Diseases Policy, where increased effort must be placed on prevention through early detection, while a clear integrated approach involving the various levels of home, medical setting, and central specialist authorities, has to be adopted for its sufficient management. spinitCompanion solution fits these components of EU Health Strategy by offering an innovative product that delivers fast and precise blood test results, allowing for the prevention and early detection of health complications. biosurfit proposes a product that is consistent with “spending smarter but not necessarily more” by reducing the direct costs of standard blood tests and the associated costs related to unscheduled emergencies, rescue medications and hospitalizations. Looking specifically into the diabetes strain of chronic disease, the absolute number of diabetics in the EU will rise from approximately 33 million in 2010 to 38 million in 2030. In 2010, approximately 9% of the adult EU population was diabetic. In response with the chronic diseases policy, the EC had launched the European Diabetes Indicator Project (EUDIP) and its follow up European Core Indicators in Diabetes (EUCID), by harmonising EU-wide indicators of diabetes for effective early detection, prevention and monitoring (Figure 4). Through this, strides of improvement have been made in defining diabetes thresholds on relevance, validity, sensitivity, reproducibility, and responsiveness. But their efforts are left stranded, or benefits not fully felt, without quick and efficient testing mechanisms made readily available en-masse (decentralisation).

2) Keeping people healthy and active for longer has a positive impact on productivity and competitiveness. Chronic diseases are health conditions that require continuous care management over a period of years or decades. While an obvious by-product of chronic illness is absenteeism from work, more commonly, chronically ill patients continue to work at lower productivity levels (‘presenteeism’), particularly if they cannot afford to take extended leave. In Europe, productivity losses from chronic disease can range from 17.1% for low risk individuals to 34.5% for those of high-risk . Delayed treatments definitely worsen this problem with chance of developing acute illness or episodes associated with disease’s complications. spinitCompanion adoption will reduce the management burden on the patients enabling them to be better monitor changes in health status, and medically intervene if required. This will help decreasing the negative impact of the disease on the workplace promoting an improved general wellbeing for the patients.