Miracor Medical SA Cutting-edge cardiac care

Specialising in the prevention of heart failure, the start-up Miracor Medical was formed in 2008 in Austria. Now based in Belgium, the company relies on its 22 full-time equivalent staff for the development of a promising therapy and technology platform: PiCSO®.

Heart failure, a chronic disease with one of the main causes being heart attacks, is a global epidemic costing $100 billion every year in the United States and representing 3.5% of the National Institute for Health and Disability Insurance (INAMI) in Belgium (more than cancer). There are 3 million cases of heart attacks per year in the world and 15,000 in Belgium. It was to respond to this large unmet medical need that Miracor Medical was set up by Prof. Mohl, an Austrian cardiac surgeon who was the originator of the PiCSO therapy and platform (Pressure-controlled Intermittent Coronary Sinus Occlusion). The aim was to develop a procedure that had been done manually (inflation and deflation of a balloon in the coronary sinus) and to transform this into an automated, controlled and reproducible therapy that could be customized for each patient. The current PiCSO system was the result of clinical trials started in 2010 and consists of a catheter inserted in the coronary sinus (at the exit of the heart), ending in a balloon that is intermittently inflated and deflated, and linked to a console table that records the patient’s parameters. The inflation of the balloon enables the occlusion of the vessel and thereby stops the blood flow out of the heart, which increases pressure on the heart, leads to the redistribution of the blood and improves microcirculation and perfusion in the heart while the heart attack is being treated. This is an adjunct therapy for the interventional cardiologist who can use PiCSO at the same time as placing a stent to unblock the artery. More than 200 patients have already been treated with PiCSO in the context of five different trials since 2010. In May 2018, the OxAMI-PICSO trial carried out by Oxford Heart Centre (Oxford University Hospitals, NHS Foundation Trust) was presented at the EuroPCR Congress in Paris, and published simultaneously in a peer-reviewed journal, and its results were deemed very positive. In fact, the study demonstrated that PiCSO reduced infarct size after a primary angioplasty. In July 2019 Miracor announced the start of its European randomized study, PiCSO-AMI-I, to further evaluate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients. The recruitment of 144 patients is underway, 7 English centers should be active by the end of 2019 and in 2020 two additional centers will be opened in France and Switzerland. The results are expected in 2021. In August 2019 Miracor Medical has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its PiCSO® Impulse System for treatment of STEMI patients. The FDA Breakthrough Device designation is intended to speed time to market for treatments of life-threatening or irreversibly debilitating diseases or conditions and recognizes the novelty of the PiCSO Impulse System and its potential to benefit patients with anterior STEMI heart attacks. Moreover Miracor Medical is in discussions with the FDA in the United States to launch an even more ambitious pivotal trial to be carried out simultaneously in the United States and in Europe on approximately 400 patients. This is due to start in 2021. Miracor is also in advanced discussion with the notified body to obtain the CE-mark for the beginning of the year 2020. This is equivalent to the marketing authorization in the European Union. Thanks to these trials, Miracor Medical plans to concentrate its efforts on the generation of high quality clinical data in order to be able to gain reimbursement coverage (every country having its own procedures) and to benefit from the recommendations of the medical societies. The start-up also wishes to improve its products with a view to continuous development. They already have next generation products in their sights. This gives another reason for hope to all those people suffering with chronic heart disease in the world. © Miracor Medical SA Mr Olivier Delporte, CEO of Miracor Medical

© Miracor Medical SA

Miracor Medical SA Rue de Bruxelles 174 - E40 Business Park - B-4340 Awans Tel.: +32 (0)4 220 88 00 Email: office@miracormedical.com http://www.miracormedical.com