September 14, 2011 — Miracor Medical Systems GmbH announced today the company has secured $10 million to commercialize its Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system. It offers a new approach to reduce myocardial injury following percutaneous coronary intervention (PCI).
The device revitalizes ischemic myocardium, thereby providing a cardioprotective effect called cardioprotected PCI (cPCI). Initial clinical results show positive effects on major adverse cardiovascular events (MACE), restenosis rates, and long-term event-free survival.
This is the first closing of the series B financing round. Second closing is pending approval by other European venture investors and potential new investors. The financing round was supported by Austria Wirtschaftsservice (aws) and German venture capital investor SHS Gesellschaft für Beteiligungsmanagement, as well as the existing investors Earlybird and Delta Partners.
Since its foundation in May 2008, Miracor has secured a total of $21.3 million in venture capital and grants to develop the company.
“We find Miracor an extremely interesting investment opportunity,” said Hubertus Leonhardt, partner at SHS. “We believe that there is a big unmet clinical need to improve the outcome in acute coronary syndrome patients, and Miracor has convincingly demonstrated that its PICSO technology, patent portfolio, clinical outcomes and future trials will address this unmet clinical need.”
Miracor will initiate the post CE mark Prepare RAMSES clinical trial in 2011 and will also start initial sales activities in select hospitals in Europe. The company plans to initiate the randomized multi-center RAMSES trial in 2012 at the same time it will expand its European sales activities.
The PICSO system consists of the Miracor PICSO Impulse Console and the disposable, single-use Miracor PICSO Impulse Catheter.
Timely myocardial reperfusion using primary PCI remains the most effective treatment strategy for limiting infarct size, reducing left ventricular remodeling, and improving clinical outcomes following ST-segment elevation myocardial infarction (STEMI). Despite optimum primary PCI, the mortality and morbidity following a STEMI event remains sizable. Primary PCI alone is not enough to eliminate the risk for future cardiovascular events. Paradoxically, the process of restoring coronary blood flow can in itself exacerbate the myocardial injury.
Recent studies have also shown that reduced door-to-balloon time does not reduce mortality in STEMI patients.
For more information: www.miracormedical.com