Periodic Reporting for period 1 - Infarnosys (Novel biomarker diagnostic system for the assessment of the prognosis of acute myocardial ischemia/reperfusion injury and infarction and the effectiveness of the treatment)
Berichtszeitraum: 2015-09-01 bis 2016-02-29
The Infarnosys project aims to launch a novel, combined biomarker diagnostic system on the market that will help clinicians and laboratories to earlier and better diagnose cardiac ischemia/reperfusion injury and prognosticate the long term outcome and the effectiveness of the treatment. The innovative process measures MMP-2, MMP-9 and nitrotyrosine levels in artery blood samples and enables testing MMP inhibitors. Our diagnostic marker combination has been tested already in a pre-clinical and a pilot clinical study and the results were published in international peer-reviews journals. . A Phase 2 project would aim a full scale pre-clinical and clinical study and the development of an automated gelatin zymography device to enable routine clinical application of our diagnostic method. In the Phase 3 period our main target customers, cardiologists, clinical chemists and researchers will be reached through our existing sales channels and through partnerships already negotiated.
Our aim in the Phase 1 project was to assess further the technical and commercial feasibility of our approach and to prepare for the finalization of the development work including a full clinical validation. The work performed towards this objective included performing a market research and cost analysis; preparing the preclinical and clinical study documentation; carrying out a detailed freedom-to-operate search as well as devising an intellectual property protection and a market launch strategy. Based on this work we have been able to forecast potential commercial outcomes and asses potential business models under various market scenarios.
For both men and women, coronary artery disease is the leading cause of death in Europe in spite of the fact that 80% of premature heart diseases are preventable. Earlier and better diagnosis of cardiac ischemia and reperfusion injury is crucial for reducing the number of deaths connected to cardiovascular diseases. Measuring MMP and nitrotyrosine levels enables predicting the outcome of heart attack and helps to start individual treatment much earlier; and also allows for more sophisticated monitoring of the treatment. In addition to our main focus area (CVD), the automation of gelatin zymography has added value in research applications, as well as in other diagnostic segments.