The First In Vitro Diagnostic Device for the Early Detection of Cardiac Ischemia

ended

Cardiovascular diseases (CVD) are the leading cause of death/morbidity across the globe, accounting for 31% of all deaths in 2015. In the same year almost 49 m Europeans were living with CVD. Early detection of ischemia is essential to prevent the progression of heart damage and the irreversible tissue damage (necrosis) that can lead to heart failure. AGLYC is an IVD lab-based test for the early detection of ischemia (15 mins event onset) in the absence of the irreversible necrosis of the tissue. AGLYC demonstrates a 98% sensitivity in detecting the presence of ischemic heart disease. Our main competitive advantages are high sensitivity, early detection of ischemia, and cost effectiveness. The global in vitro diagnostics (IVD) market was valued at $64.02 bn in 2017 and is projected to reach $87.93 bn by 2023, at a CAGR of 5.2%. The laboratory diagnostic test (lab-based) market represents 86% of the total diagnostic testing market. Specifically, the market for lab tests related to acute cardiac ischemic events represented about $166 m in total sales in 2015. We have estimated a lab-based target market of >70 m patients. Our main business model will be a sublicense model based on the development of a laboratory-based test that we will develop and then sublicense to either a medical device company (MedTech) or to a pharmaceutical company. With this model and the successful completion of the SMEI phase 2 we estimate an EBITDA of around €23 m. The company closed a first funding round of €2.4 m on October 2017 to cover nearly 65% of the expenses of the development plan. GlyCardial Diagnostics, S.L. was founded in 2017 as a spin-off of the ICCC- IR-Hospital de la Santa Creu i Sant Pau and the Spanish National Research Council with the focus of developing a novel IVD test for cardiac ischemia. Our vision is to improve the early diagnosis of cardiac ischemic events, reducing the impact of the disease on patients’ lives and society as a whole.