Device for non invasive collection of exhaled breath. The individual has to breath normally into the Pneumopipe for three minutes. After this 3 minutes the exhaled breath has been collected into a cartridge which can be stored, delivered or measured by thermally desorbing its content into an instrument for gas and vapour analysis.

Pneumopipe is a prototype currently sitting between TRL4 and TRL5, which has been validated in relevant environments. So far a library of more than 2000 breath fingerprints have been built by performing measurement campaigns on different diseases in different hospitals, including the assessment of comorbidities and confounding factors.

Patent Status

DEPOSITATO

Patent Number

EP12425057 20120320

Priority Date

20/03/2012

License

EUROPE

Market

In Italy an estimated 2.6 million men and women have COPD (Chronic Obstructive Pulmonary Disease)
This is the diesase most investigated via breath analysis
Thus, this number is understimated with respect to the spectra of possible diseases to which this technique could be applied

Problem

The problem is the early diagnosis and monitoring of chronic diseases. These issues ask for a simple technique/instrument
to be used for frequent tests at home/pharmacy/point-of-care by not specialized operators.

The solution could be a non invasive examination method. Exhaled breath is a non-invasive access point to human body and it could also give information related to respiratory, metabolic and systemic diseases.

The Socio-economic impact of this technique is in the augmented possibility of preventing exacerbations, re-hospitalisation and adverse outcomes, by a capillary network of point-of-care and via an active support of patients at home.

Current Technology Limits

Exhaled breath analysis is currently perfomed with two strategies: identification and quantification of the Volatile Organic Compounds (VOCs) in exhaled breath; capture of a fingerprint of exhaled breath.
Many ‘breath tests’ are based on the first strategy and are addressed to the identification of specific biomarkers associated to specific diseases. When no biomarker is known, the application of this technique is like looking for a needle in a haystack. Moreover it is expensive and often needs specialized operators.
The fingerprint approach is based on arrays of chemical sensors. It is excellent for disease discrimination, classification, diagnosis when no biomarkers are known, it is also easy to use, quite cheap and fast. However, fingerprinting needs large libraries of exhaled breaths as training set. The main problem of both the approaches is the lack of a standard procedure for exhaled breath collection, transport and storage, which is solved by Pneumopipe.

Our Technology and Solutions

The Pneumopipe facilitates collecting the breath exhaled by an individual into a mouthpiece. The absorbing cartridge that resides within the chamber, then catches and traps the volatile compounds.
In this way the exhaled breath is entrapped in a case with the size and the shape of a pen (the cartridge).
This cartridge can be measured in a second time and not immediately after the execution of the exam with the patient.
In this way, the sample of exhaled breath can be transported and stored.
Some value propositions should be: the installation of a network of point-of-care for exhaled breath monitoring in pharmacies and ambulatories; the creation of a biobank of exhaled breath. The revenue streams linked to these services should be: device provision, maintenance, and update; supply of consumables; network and cloud services.

Advantages

Exhaled breath collected via Pneumopipe can be transported and stored. The main part of the instruments for exhaled breath analysis can be only used immediately after the collection of the sample. Many of these techniques are based on sampling bags, which are difficult to be stored. Moreover the sampling procedure operated via bag is not standard and so scarcely reproducible.
Pneumopipe allows exhaled breath retain in a small mean, thus it is suitable for the development of capillary network of screening/monitoring and it encourages multicenter studies.

Killer Application

The monitoring of COPD patients with the support of pharmacies and general practitioners to prevent exacerbation and monitoring therapy.

Roadmap

Currently Pneumopipe can have three market addresses:

1) exhaled air sampler for analysis of existing breath tests;
2) exhaled air sampler for Biobanking purposes (the transportability and the storage capacity of the sample suggest its use for medium and long-term storage, so far never made with exhaled samples);
3) exhaled air sampler for clinical studies at University Polyclinics oriented to breathprinting. In this case, the most indicated and most promising disease, in our opinion, is COPD.

Review the Technology
TRL 1
TRL 2
TRL 3
TRL 4
TRL 5
TRL 6
TRL 7
TRL 8
TRL 9

TRL

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