Miracor secures financing to support PiCSO clinical study

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The PiCSO Impulse System

Miracor Medical has announced the closing of a €24 million series-E round of financing. The round was led by a new corporate strategic investor joined by co-investor Yonghua. Current investors Earlybird, Noshaq, Quest for Growth, SFPI-FPIM, SRIW and another corporate strategic investor also supported this financing. The funds will be used to advance the PiCSO clinical study program, which will recruit and randomise up to 750 patients in three studies in Europe and the USA. Additionally, commercialisation will start in Europe.

PiCSO therapy is delivered by interventional cardiologists during the primary PCI (Percutaneous Coronary Intervention) procedure in patients experiencing anterior ST-elevated myocardial infarction (STEMI).

According to Miracor, the PiCSO Impulse System reduces the infarct size via its unique mechanism of action of intermittently occluding the coronary sinus outflow, which redistributes blood to deprived myocardium and potentially leads to improved microvascular function. Infarct size reduction is strongly correlated to improvement in heart failure hospitalizations and reduced mortality, the company said in a press release. The PiCSO Impulse System has received ‘Breakthrough Designation’ from the US Food and Drug Administration (FDA) in 2019 and the CE mark in June 2020.

“We are very happy to welcome strong new investors and to receive the continued endorsement and belief in Miracor from our existing shareholders. Following the recent CE mark, we have hired a very experienced commercial leader, James Hallums who will build the strategy to prepare the controlled commercial launch planned for H2 2021. We look forward to this exciting next phase of the company.” said Olivier Delporte, CEO.

Miracor is currently recruiting patients in a landmark European randomised controlled trial, PiCSO-AMI-I, to further demonstrate the benefits of PiCSO therapy as compared with conventional PCI for the treatment of anterior STEMI patients.

The development of Miracor’s PiCSO technology is supported by a reimbursable cash advance from the Walloon Region since August 2017. This financial grant covers 55% of the technical and clinical research for the product.


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