EasyFlow: New asthma monitor to enable the effective control of asthma

Informazioni relative al progetto

BREATHE

ID dell’accordo di sovvenzione: 710070

DOI

10.3030/710070

Progetto chiuso

Data della firma CE 12 Novembre 2015

Data di avvio 1 Dicembre 2015

Data di completamento 29 Febbraio 2016

Finanziato da

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

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

ANAXSYS TECHNOLOGY LIMITED
United Kingdom

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

Periodo di rendicontazione: 2015-12-01 al 2016-02-29

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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