Miracor reports successful completion of the ‘Prepare PICSO’ clinical trial

Miracor Medical Systems GmbH announced today the successful completion of the pilot study of its PICSO® (Pressure-controlled Intermittent Coronary Sinus Occlusion) System, designed to improve acute coronary syndrome (ACS) revascularization following primary percutaneous coronary intervention (PCI). (Click here for 5 minute “Corporate Preview” video with PICSO® animation.)

The “Prepare PICSO®” pilot study of stable angina patients included ten (10) patients of principal investigator Prof. Dr. med. Jan Piek at the Academic Medical Center, Amsterdam, The Netherlands. It is planned that Miracor will now initiate the pivotal RAMSES clinical trial of PICSO®.

“For all ten patients, we needed less than fifteen minutes from femoral vein puncture to safe insertion of the PICSO® catheter into the coronary sinus,” said Prof. Piek. “Thus, PICSO® is simple to insert at a site that is very familiar to us. Also, the PICSO® catheter is easy to maneuver and is continuously stable during the PCI procedure. We were especially pleased to observe a notable reduction of ischemia as documented by the surface ECG ST-segment shift in several patients, clearly suggesting that PICSO® has a potential cardioprotective benefit. In summary, the findings in this pilot study are extremely encouraging as we now look forward to the broader RAMSES clinical study,” added Prof. Piek.

“These first-in-man (FIM) clinical data affirm the diminishment of ischemia with the use of PICSO®,” said Prof. DDr. Werner Mohl, inventor of the PICSO® concept and Founder of Miracor.

“Successful completion of our “Prepare PICSO®” pilot study is a major milestone for Miracor,” said Jon H. Hoem, Miracor CEO. “We are especially pleased that all ten patients are doing well. We now look forward with great anticipation to leveraging these results in our pivotal RAMSES clinical trial of PICSO®, which we expect to commence later in 2011. We will keep our momentum, because there is a dire, unmet clinical need for PICSO®: nearly 30% of critical heart attack patients have suboptimal microcirculatory blood flow even after coronary angioplasty, which increases their risk of death within a year by almost three-fold. PICSO® is designed to help these patients.”

About PICSO®
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®) system offers a new and innovative approach to improve microcirculatory flow, reduce myocardial injury and to revitalize ischemic myocardium. Initial clinical results show positive effects on MACE, restenosis rates, and long-term event-free survival. The 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.