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Disposable nitric oxide POC (point-of-care) test for home care easy management of asthma in chronic patients

Periodic Reporting for period 1 - ASTHMAPOC (Disposable nitric oxide POC (point-of-care) test for home care easy management of asthma in chronic patients)

Reporting period: 2014-10-01 to 2015-01-31

The ultimate goal we seek in the ASTHMAPOC project is bringing to the market the first low-cost point of care device for self-patient management of chronic asthma.
Asthma is a chronic disease characterized by inflammation of the air passages resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.
Self-management has been recognized as the best approach to overcome the current challenges in asthma management. Of particular interest in relation to asthma management is the measurement of fractional exhaled nitric oxide (FENO) in breath. FENO concentration in exhaled breath has been shown to be elevated in patients with asthma and seems to be related to the degree of eosinophilic inflammation
The solution we propose in the ASTHMAPOC project to make FENO measurement devices accessible to the patients for self-management of asthma is based on the following three key device features:
• Portability: the device will be an electronic device capable to read the signal coming from electrochemical sensors. Electrochemical sensors belong to a type of sensor technology compatible with small and portable devices.
• User friendliness: The device will deliver the FENO measurement in two ways. On one side, an LCD display will provide a numeric value of FENO concentration in exhaled breath. ON the other side, a 3-colour code (green, yellow and red LED lights), will indicate in an easy way whether the FENO level determined in low, medium or high, according to the standardized FENO cut points for children and adults).
• Affordable price: price affordability will be achieved by making the electrochemical sensors disposable (one use). The type of electrochemical sensors we will use are those known as Organic field-effect transistors (OFETs).
The market for ASTHMAPOC is the point-of-care devices market, a specific type of diagnostic devices conceived as testing at or near the site of patient care. The major market driver is the decentralization of diagnosis services from hospitals to near-patient diagnosis and monitoring.
There is no market data available for the asthma point-of-care segment because of its premature stage. The appearance in the market scene of asthma point-of-care devices has occurred only in the last 3 years, after approval of FENO standards.
There were three major objectives blocks in this feasibility study: technical, commercial and financial feasibility studies. In the same way, the work package for Phase I was structured in three tasks:

• Task 1. Evaluation of the technical feasibility (duration: 2 months). Leader: Mr. Oscar Ramirez
• Task 2. Evaluation of the commercial feasibility (duration: 2 months). Leader: Mr. Gustav Notander
• Task 3. Evaluation of the financial feasibility (duration: 1 month). Leader: Mrs. Marta Lopez

To be consistent with the structure of the planned objectives and activities, our work during these 4 months has been structured as in different sections as follows:
A) Technical feasibility
B) Commercial feasibility
C) Financial feasibility
D) Business Plan
The idea of structuring the deliverable this way, is to provide all the relevant details on the feasibility of the project from different perspectives and based on the outcomes of the feasibility study, present our 5 years business plan dealing with ASTHMAPOC development and commercialization. In each of the four sections mentioned above, we have reported on all the key activities performed during the feasibility study, as planned in the tasks of the work package listed before.
ASTHMA PREVALENCE AND COSTS: In terms of prevalence, asthma is one of the major non-communicable diseases, affecting more than 300 million people all over the world and being the major disease affecting children. It is thought to be caused by a combination of genetic and environmental factors, although the exact underlying factors are not completely understood. The stronger risk environmental factor is the exposition to inhaled substances and particles that may provoke allergic reactions or irritate the airways. The gradual increase of population living in urban areas is associated with an estimated increase of people affected by asthma up to 400 million in 2015.
Regarding costs, the economic burden of asthma is considerable both in terms of direct costs (hospital admissions and costs of medication) and indirect costs (work absence and premature death). Direct asthma cost represents approximately 1-3% of the total medical expenditures in most countries, while indirect costs account for almost 50% of the total costs. Solely in Europe, the total costs of asthma are estimated at €17.7 billion per year. The threatening figures make effective asthma management a major priority for the healthcare systems.
COST SAVINGS ACHIEVABLE BY ASTHMAPOC: ASTHMAPOC is a point-of-care device aimed at the determination of FENO levels in exhaled breath by the patients at home. FENO determination has been demonstrated to be a very useful tool in monitoring this disease so to enhance asthma management. Similar devices like NIOX MINO have proved to reduce the cost in asthma diagnosis by 51€ (£43) per patient and the costs of asthma management by an average of 537€ (£341 for patients with mild to severe asthma and cost-savings of £554 for those with moderate to severe asthma). These results are really encouraging in what refers to the use of FENO determination as an alternative for the diagnosis and clinical management of asthma. However, the ASTHMAPOC device differs from the NIOX MINO device in one important key feature, ASTHMAPOC is conceived as a product for patient use, while NIOX MINO is intended as a device for clinical use.
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