FABPulous BV closes Series B Funding; Begins commercial activities with rapid 5-minute POC IVD for AMI

MAASTRICHT, Netherlands - Feb. 4, 2015 - PRLog -- FABPulous B.V. (Maastricht, Netherlands) announced the successful closure of their €1.8m Series B funding round by Thuja Capital Healthcare Fund (Utrecht), Health Innovation Fund (Utrecht), LIOF (Maastricht) and Limburg Ventures (Maastricht) as well as existing investors and undisclosed new investors.

The True Rapid Test concept is extremely simple to apply and uses a unique combination of rapid whole blood filtration and subsequent lateral flow immunoassay to provide an accurate result within 5 minutes. The device is disposable and there is no need for equipment, which allows the test to be completed by non-biomedical staff during the critical moment of the Patient–Doctor consultation at the point of care.

H-FABP (Heart Fatty Acid Binding Protein, FABP-3) is abundantly present in cardiac myocytes and is released into the blood stream both earlier and in higher quantities than troponin during heart muscle ischemia caused by an AMI. Its absence, when used in conjunction with clinical signs and symptoms, offers a very high negative predictive value (NPV) of ≥ 98% in primary care settings. When the initial high sensitivity troponin laboratory result is added in the MACS rules based approach in the Emergency Department, the NPV increases to better than 99.5% (Body, 2014).

“The use of a 5 minute H-FABP test at point of care promises to reduce the number of patients at low risk of AMI being admitted for observation by 25–40% preventing unnecessary bed-blocking, reducing the exposure of patients to the medical and socio-psychological risks of hospitalization and offers substantial savings of financial and healthcare resources,” says company CEO, Diederik Engbersen.

Chairman of the Supervisory Board, Michel Briejer of Thuja Capital added, “The H-FABP True Rapid Test® is the type product that will have a major impact in the healthcare of tomorrow, which will be geared towards increased efficiency while retaining quality. By providing doctors with the right tools they can make better informed decisions. ”

About Acute Myocardial Infarction:

Between 1–2% of the general population presents for a medical consultation suffering from chest pain every year. Patients presenting with chest complaints caused by acute coronary syndrome (ACS) require urgent referral to a specialist setting as favourable outcome is inversely related to the time interval between onset of complaints and appropriate treatment. In emergency medicine, typically 60% of chest pain presentations will be diagnosed as potential risk of ACS yet only 15–20% of these will be finally diagnosed with AMI. The universal guidelines for the diagnosis of myocardial infarction include ECG (the definitive diagnosis for ST segment elevated myocardial infarction; STEMI) and changes in blood concentration of cardiac troponins (Tn), given their virtual absolute specificity for heart muscle. However, troponins appear in plasma only 3–8 h after onset of myocardial injury, which is often too late to influence the initial triaging process. Thus, many patients will be admitted for observation to rule out an MI when the final assessment of the diagnostic tools is delayed.

Recently published research by the Manchester Acute Coronary Syndromes (MACS) group (Body, 2014) supports a protocol – the MACS Rules – that includes a combination of ECG, hsTn, and H-FABP results coupled with strongly indicative clinical symptoms such as persistent angina, radiating chest pain, sweating or vomiting. Such a protocol has the advantage of identifying low risk patients within a 4 hour window with a Negative Predictive Value of 99.8%. The 5-min instrument-free attributes of the FABPulous True Rapid Test mean that an H-FABP test can be carried out during final Admit/Discharge decision, replacing the “Delta Troponin”, maximising the sensitivity and ensuring best possible coverage of cardiac biomarkers, particularly in cases when the timing of the onset of symptoms is uncertain.

References:

Thygsen K, Alpert JS, Jaffe AS, et al (2012). Third universal definition of myocardial infarction. European Heart Journal 33, 2551–2567
Body R, Carley S, McDowell G, et al. (2014) The Manchester Acute Coronary Syndromes (MACS) decision rule for suspected cardiac chest pain: derivation and external validation. Heart Published Online First: 29 April 2014. doi:10.1136/heartjnl-2014-305564
Glatz JFC and Mohren R (2013). Plasma reference values of heart-type fatty acid binding protein, the earliest available plasma biomarker of acute myocardial infarction. Health. 5, 1206-1209
Glatz JFC and Renneberg R (2014). Added value of H-FABP as a biomarker for the early evaluation of suspected acute coronary syndrome. Clin Lipidol. 9 (2), 205-220

About FABPulous:

FABPulous is a venture capital-backed company that was spun out of Maastricht University at the end of 2008. In December 2009 FABPulous closed a first equity financing round co-led by Thuja Capital, Health Innovations, Limburg Ventures and NV Industriebank LIOF. FABPulous develops and markets pioneering Point of Care (PoC) solutions for better diagnostics in primary care and emergency medicine. It currently consists of two legal entities, FABPulous B.V. with the head office in Maastricht, The Netherlands; and FABPulous Ltd, based in Cambridge, UK at which site the commercial activities for the group are executed. Its partners include Diagnostic Consultancy Network (DCN), Carlsbad CA, US for the development of the lateral flow detection technology; Symbient, Carlsbad CA, US for the design and development of the integrated device; and International Point of Care (IPOC), Toronto, Canada for the manufacturing of the product.