The invention consists in the use of low-field nuclear magnetic resonance (LF-NMR) for the monitoring of patients affected by cystic fibrosis (CF). The method makes it possible to indirectly evaluate the pulmonary function of patients with CF by analyzing a sample of sputum; the result is immediate and allows you to intervene immediately in the event of an infection, in order to prevent further lung damage.

Patent status

SUBMITTED

Priority Number

IT2016UA04292

Priority Date

10/06/2016

License

EUROPE

Market

TAM – total addressable market
The whole western countries population (EU + USA).

SAM – serviceable addressable market
The whole western countries population (EU + USA).

SOM – serviceable obtainable market
European market

Problem

Cystic fibrosis (CF), the most frequent genetic disease in Caucasian populations, and chronic obstructive pulmonary disease (COPD) have in common the presence of a very viscous pulmonary mucus, due to the pathological increase in the concentration of substances such as proteins, alginates, white blood cells (index of infection), bacteria and mucins. This entails the onset of an inflammatory state due to reduced lung functionality (most CF patients die of respiratory failure). CF and COPD represent a significant health and social burden due to the number of affected patients and management costs, mainly related to constant monitoring of lung function / inflammation.

Current Technology Limitations

The most common tests to evaluate inflammation / lung functionality are forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), pulmonary mucus culture and evaluation of inflammation markers. If FEV1 and FVC suffer from poor repeatability as they are ‘patient dependent’, other tests require long lead times and high costs. For example, in the US, the cost of monitoring lung function in CF patients increased from US $ 18,715 in 2001 to US $ 29,718 in 2007 (+ 61%).

Killer Application

The starting point is to spread the proposed technique among public hospitals and private centers affiliated with the NHS that carry out tests on lung function / inflammation.

Our Technology and solutions

The idea behind this patent consists in the development of a simple, quick, precise and cheep test able to detect the effect of the pathological components of the mucus (obtained by simple “sputum” expectoration). These, in fact, induce to reduce lung functionality and promote inflammation. To detect the amount of pathological components of sputum, the use of Low Field Nuclear Magnetic Resonance (LF-MNR) is proposed, which measures the spin-spin relaxation time (T2m) of the hydrogens of the water trapped in the mucus. In fact, the higher the concentration of the pathological components, an indication of a worse clinical condition of the patient, the lower T2m which indirectly becomes an index of lung function / inflammation.

Advantages

The proposed technique for evaluating lung function / inflammation represents a rapid, simple, reliable and low-cost approach suitable for very frequent monitoring of lung status. Indeed, very often, it is necessary to be able to have very rapid feedback (during day-hospital visits, for example) on the effect of the prescribed antibiotic therapy. The evaluation of T2m aims precisely to meet this need for speed by means of a low-cost and remarkably simple technique that does not require the employement of particularly experienced technicians.

Roadmap

The patent marketing strategy simply implies the dissemination of the proposed technique to hospitals, biomedical research centers and pharmaceutical companies involved in the production of drugs aimed at reducing inflammation and improving lung function such as mucolytics and antibiotics.

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