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BREATHE Informe resumido

Project ID: 710070
Financiado con arreglo a: H2020-EU.2.3.1. , H2020-EU.3.1.

Periodic Reporting for period 1 - BREATHE (EasyFlow: New asthma monitor to enable the effective control of asthma)

Reporting period: 2015-12-01 hasta 2016-02-29

Summary of the context and overall objectives of the project

Asthma affects the quality of life of millions of sufferers globally and causes a huge economic burden each year; asthma treatment is estimated to cost €17.7bn and the cost of lost productivity €9.8bn. It is estimated that in Europe there are 30 million asthma sufferers and 15, 000 will die each year from an asthma attack even though the drugs used to treat asthma are safe, effective and if used correctly, would prevent many of these deaths. Asthma attacks result from ineffective monitoring leading to inadequate doses of prescribed drugs and therefore poor control of symptoms. Monitoring is vital as asthmatics will often not notice a gradual worsening of symptom and will not adjust their medication accordingly potentially leading to a severe attack. Peak flow meters are currently used by asthmatics to monitor symptoms on a regular basis but compliance is poor as they are difficult to use, particularly in the young or old, the technique required can cause exacerbation of symptoms and the output requires interpretation. We have developed a prototype easy to use home monitoring device that uses tidal breathing to generate breath profiles that change as symptoms deteriorate. Patients can then easily see whether they need to increase their asthma medication to control their symptoms and avoid an asthma attack.

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

During this Phase 1 project, we have determined that the concept behind the Breathe EasyFlow device is both technically and commercially feasible in conjunction with a comprehensive risk and mitigation strategy. We have identified the technical requirements (URS) to develop both the hard and software along with the associated costs, and where necessary, the most suitable partners, to form a supply chain to manufacture the device in suitable volumes. The regulatory pathway has been identified in accordance with EU Medical Device Directives along with an appropriate clinical strategy to gather the evidence needed for CE marking and device adoption.

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)

We have identified the activities needed for adoption, reimbursement and uptake of the device in different Healthcare systems in conjunction with a clear and robust sales strategy covering different routes to market. An IP review has highlighted our current position along with some different methods for IP protection of the device. Having completed our Phase 1 feasibility study, we have devised an achievable and robust development and validation plan, along with plans for commercialisation, including definition of our preferred route to market.

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