Miracor receives $3.5 million cash infusion to begin pivotal clinical “RAMSES” trial of its PICSO system

designed to improve myocardial perfusion following primary PCI
“One in three heart attack patients has impaired blood flow even after coronary angioplasty, increasing the risk of death within one year by almost 300 percent. PICSO is designed to help these at-risk patients.”
Jon H. Hoem, CEO, Miracor Medical Systems

VIENNA, Austria, Feb. 28, 2012—Miracor Medical Systems GmbH announced today that it has received a cash infusion of $3.5 million (€2.6 million) in the form of a research grant and loan from the Austrian Research Promotion Agency (“FFG”), the national funding institution for applied research and development in Austria.

The funding will be used primarily to commence the pivotal clinical trial—RAMSES—of the Company’s PICSO (Pressure-controlled Intermittent Coronary Sinus Occlusion) system (click here for the 2 minutes animation of the PICSO technology). The RAMSES trial is designed to understand how PICSO can help acute coronary syndrome patients with large anterior infarcts having ECG changes with poor microcirculation after revascularization.

In a feasibility study of stable angina patients, the PICSO procedure was performed successfully in 10 patients by Prof. Dr. med. Jan Piek and his group at the Academic Medical Center, Amsterdam, The Netherlands. Based on these outstanding clinical results and the availability of fresh capital, Miracor will soon initiate the pivotal ‘RAMSES’ study in acute coronary syndrome patients.

“Despite a successful primary PCI, suboptimal myocardial reperfusion still occurs in about 30 percent of STEMI patients, and this high incidence is strongly linked to unfavorable outcomes for patients,” said Jon H. Hoem, Miracor CEO. “Our feasibility study demonstrated that PICSO clearly reduces ischemia acutely when an infarct was induced in stable angina patients, which is why we are delighted to have this new funding from FFG supporting the RAMSES pivotal clinical trial in STEMI patients,” added Hoem.

About PISCO® and cardioprotected PCI (cPCITM)
Timely myocardial reperfusion using primary Percutaneous Coronary Intervention (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. Clearly, 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. Miracor’s Pressure-controlled Intermittent Coronary Sinus Occlusion (PICSO®) Impulse System offers a new and innovative approach to reduce myocardial injury and to revitalize ischemic myocardium thereby providing a cardioprotective effect called cardioprotected PCI (cPCITM). Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The CE-marked PICSO® system consists of the Miracor PICSO® Impulse Console and the disposable, single-use Miracor PICSO® Impulse Catheter.

About Miracor Medical Systems GmbH
Based in Vienna, Austria, privately held Miracor is commercializing a unique and potentially disruptive technology, PICSO®, for acute coronary syndrome (ACS), heart failure, and cardiac surgery patients. The Company’s objective is to establish PICSO® as the standard of care for heart attack patients, thereby improving their quality of life. The initial market opportunity for PICSO® is 30% of all ACS patients treated per year, which translates into more than 350,000 patients in the U.S. and Europe.

The Miracor PICSO® Impulse System is CE-marked and can be used during coronary revascularization procedures following myocardial infarction and other types of acute coronary syndromes to intermittently increase the pressure in the coronary venous system. The technology is for investigational use only in the United States at this time.

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