Miracor Medical has raised €24m in Series E financing round to fund the PiCSO clinical trial, which will recruit and randomise approximately 750 patients in three studies across Europe and the US.
Interventional cardiologists deliver PiCSO therapy during the primary percutaneous coronary intervention (PCI) procedure in patients, experiencing anterior ST-elevated myocardial infarction (STEMI).
The company’s PiCSO Impulse System is designed to reduce the infarct size by intermittently occluding the coronary sinus outflow. It supports the redistribution of blood to deprived myocardium and potentially improves microvascular function.
Infarct size reduction is considered to be strongly correlated to improvement in heart failure hospitalisations and reduced mortality.
The PiCSO Impulse System obtained breakthrough designation from the Food and Drug Administration (FDA) last year and the CE-Mark in June.
Miracor also plans to use the proceeds to advance the commercialisation of the system in Europe.
The latest financing round was led by a new corporate strategic investor and joined by co-investor Yonghua.
It was also joined by the company’s current investors Earlybird, Noshaq, Quest for Growth, SFPI-FPIM, SRIW and another corporate strategic investor.
Miracor Medical CEO Olivier Delporte said: “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.”
The company is currently enrolling patients in its European randomised controlled trial called PiCSO-AMI-I.
The trial will demonstrate the benefits of PiCSO therapy for the treatment of anterior STEMI patients compared with conventional PCI.
In another major development in the field of cardiology, Cardiac Dimensions received the Australian Therapeutic Goods Administration’s approval for its Carillon System.
Carillon System is a right heart transcatheter mitral valve repair (TMVr) device designed to treat functional mitral regurgitation (FMR) in patients with 2+, 3+ and 4+ grade mitral regurgitations.
Cardiac Dimensions CEO and president Rick Wypych said: “This is a significant milestone as Australian patients with heart failure can now be treated earlier in their disease state with a minimally invasive treatment for mitral regurgitation.”
Approximately 26 million people are estimated to be affected by heart failure worldwide, while nearly 70% of these patients suffer from FMR.