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CORDIS

Validation of a point-of-care H-FABP test for a rapid exclusion of Acute Myocardial Infarction in patients with cardiac complaints.

Obiettivo

There is a pressing need for improvement of the diagnosis of acute myocardial infarction (AMI) for healthcare professionals (HCP). 1–1,5% of the population consult a physician each year with chest pain complaints. While the majority (60–80%) of these patients are sent to a hospital for further inspection, eventually AMI is diagnosed in only 8–18% of these cases. Consequently, a rapid, objective test that helps to better select patients suspected of AMI by HCPs would reduce the number of unnecessary hospital referrals and admissions, thereby saving costs and contributing to a more sustainable healthcare.

FABPulous (SME) is a medical device company spun out of Maastricht University in 2008. The core of the company is its innovative proprietary technology that allows a simple, robust and ultra-rapid diluted plasma preparation from a drop of blood. This offers great advantages over current technologies in point-of-care and home testing.

The CE-marked H-FABP True Rapid Test (H-FABP TRT) developed by FABPulous aids the HCP in ruling out AMI with a very high level of confidence. It is based on the heart-type fatty acid binding protein (H-FABP), which can be used as biomarker for AMI. With H-FABP TRT a physician is able to rule out the occurrence of an AMI for a large proportion of patients suspected of AMI. It is intended for use in both primary and emergency care.

In this project FABPulous seeks to medico-economically validate H-FABP TRT in primary (Netherlands+Belgium) and emergency care (UK) by performing two clinical trials. Outcomes of these studies lead to adoption of H-FABP TRT in medical guidelines and form the basis of a request for reimbursement towards health insurers. In this project FABPulous will improve the production process as well in order to decrease the cost price to €5 per test.

The addressable market in NW Europe alone amounts to at least 2 mln tests. The phased introduction plan leads to €8.6 mln revenue with a gross margin of €6.5 mln in 2018.

Invito a presentare proposte

H2020-SMEInst-2014-2015

Vedi altri progetti per questo bando

Bando secondario

H2020-SMEINST-2-2014

Meccanismo di finanziamento

SME-2 - SME instrument phase 2

Coordinatore

FABPULOUS BV
Contribution nette de l'UE
€ 1 633 750,00
Indirizzo
OXFORDLAAN 55
6229 EV MAASTRICHT
Paesi Bassi

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PMI

L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.

Regione
Zuid-Nederland Limburg (NL) Zuid-Limburg
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Collegamenti
Costo totale
€ 1 633 750,00