FABPulous wins €1.6m EU grant for clinical trials of 5 minuteheart attack test
July 20th 2015, Maastricht (Netherlands) – The European Union awarded FABPulous BV a €1.6 million Phase 2 grant to fund two clinical trials in the UK and Belgium/Netherlands and automate the manufacture of its 5 minute, patented H-FABP True Rapid Test®, which helps emergency medical workers quickly distinguish whether a patient with chest pain is at risk of a heart attack.
Between 1-2% of the population complains of chest pain every year. In emergency medicine, typically 60% of those patients will be diagnosed as potentially at risk of heart disease and most will be admitted to hospital for observation under the current guidelines for health care systems such as Britain’s NHS. But only 15-20%of these patients will be finally diagnosed with Acute Myocardial Infarction (AMI), or heart attack.
That means wasted beds in overstretched hospitals, unnecessary tests, demands on hospital staff, increased waiting times and rising pressure on the resources of health care providers.
The EU grant will help FABPulous produce the necessary clinical evidence to support the adoption of its 5 minute H-FABP True Rapid Test as a way for emergency medical workers to rule out heart attacks before they are required to admit patients to hospital.
“This EU grant brings FABPulous a step closer to producing the crucial tool that will rule out heart attack as a risk for a significant number of patients with chest pain, dramatically cuttingunnecessary admissions whilst reducing stress for patients,”saidFABPulous Chief Executive Officer Conor O’Brien.
The grant funding supplied by the EU’s H-2020 SME Instrument will also allow FABPulous to develop semi-automated manufacturing processes of reproducible quality, to increase manufacturing capacity of the H-FABP True Rapid Test and improve its affordability. H-FABP True Rapid Test is awhole blood IVD device that is capable of providing reliable detection of the Heart-type Fatty Acid Binding Protein (H-FABP), a small myocardial protein that is quickly detectable in capillary blood after a heart attack. H-FABP True Rapid Test combines a rapid, equipment free, sample preparation devicewith an immunoassay test that can be used during the moment of patient/clinician contact at point of care to help provide the necessary clinical evidence to discharge low risk patients earlier with minimal risk. The test can be done within 5 minutes without the need for instrumentation and is simple enough for non-technical nursing staff to run and interpret. FABPulous is a venture capital-backed company that was spun out of Maastricht University at the end of 2008. FABPulous develops and markets pioneering Point of Care (PoC) solutions for better diagnostics in primary care and emergency medicine.
About Horizon 2020 SME Instrument
As part of the Horizon 2020 programme, the European Commission is selecting potentially disruptive businesses to invest in and support as part of the SME Instrument. SMEs with a strong growth potential and the ambition to become world-market leaders can receive up to €2.5 million in funding, and world-class business support and mentoring. The instrument is structured in three phases, with the aim of transforming disruptive ideas into concrete, innovative solutions with a European and global impact.The Phase 2 projects covering Demonstration, Market Replication, R&D Concept to Market-Maturity over a period of 1-2 years are aimed to help the SME further develop its proposal through innovation activities, and draft a more developed business plan. For more information visit: https://ec.europa.eu/easme/en/horizons-2020-sme-instrument.
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 3 hours after entry to ED (Willemsen, 2015) with a Negative Predictive Value of99.8%. The 5-min instrument-free attributes of the FABPulous True Rapid Test means 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 • Willemsen RTA, van Severen E, Vandervoort PM, et al (2015). H-FABP in patients in an emergency care setting, suspected of acute coronary syndrome: optimal cut-off point, diagnostic value and future opportunities in Primary Care. Eur. J Gen. Pract.; Early Online: 1–8, DOI: 10.3109/13814788.2015.1013934 • 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. ClinLipidol. 9 (2), 205-220
About FABPulous:
FABPulous develops and markets pioneering Point of Care (POC) solutions for better diagnostic tools in primary care and emergency medicine. FABPulous is a venture capital-backed company that was spun out of Maastricht University at the end of 2008. In January 2015 FABPulous closed a €2m Series B funding round led by Thuja Capital (Utrecht), Health Innovation (Utrecht), LIOF (Maastricht) and Limburg Ventures (Maastricht) as well as existing investors and undisclosed new investors. 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.
For further information please contact:
Conor O’Brien, Chief Executive Officer – email at c.obrien@fabpulous.com
FABPulous BV FABPulous Ltd Oxfordlaan 55 St John’s Innovation Centre 6229 EV Maastricht Cowley Road, Cambridge Netherlands CB4 0WS, UK