Business Wire10.14.20
Miracor Medical SA has closed a 24 million euros 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 randomize up to 750 patients in three studies in Europe and the United States. Additionally, commercialization 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). Despite all improvements and widespread use of reperfusion strategies and adjuvant pharmacological therapies1 the one-year mortality rate for STEMI has plateaued at 14 percent and heart failure occurs in up to 28 percent of patients within the first 90 days.2 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.3,4 Infarct size reduction is strongly correlated to improvement in heart failure hospitalizations and reduced mortality.5 The PiCSO Impulse System received Breakthrough Designation from the U.S. Food and Drug Administration 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 randomized 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 percent of the technical and clinical research for the product.
Miracor Medical, located in Awans, Belgium, developed the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.
The PiCSO Impulse System is not approved for use in the United States.
References
1 Szummer, K., et al., Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. European Heart Journal, 2017. 38(41): p. 3056-3065.
2 Cahill et al. Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.
3 Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. IJC Heart & Vasculature, 2020. 28: p. 100526.
4 De Maria et al. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352- e359.
5 Stone et al. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.
PiCSO therapy is delivered by interventional cardiologists during the primary PCI (Percutaneous Coronary Intervention) procedure in patients experiencing anterior ST-elevated myocardial infarction (STEMI). Despite all improvements and widespread use of reperfusion strategies and adjuvant pharmacological therapies1 the one-year mortality rate for STEMI has plateaued at 14 percent and heart failure occurs in up to 28 percent of patients within the first 90 days.2 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.3,4 Infarct size reduction is strongly correlated to improvement in heart failure hospitalizations and reduced mortality.5 The PiCSO Impulse System received Breakthrough Designation from the U.S. Food and Drug Administration 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 randomized 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 percent of the technical and clinical research for the product.
Miracor Medical, located in Awans, Belgium, developed the PiCSO Impulse System, the first and only coronary sinus intervention designed to reduce infarct size, improve cardiac function by clearing microcirculation and potentially reduce the onset of heart failure following acute myocardial infarction.
The PiCSO Impulse System is not approved for use in the United States.
References
1 Szummer, K., et al., Improved outcomes in patients with ST-elevation myocardial infarction during the last 20 years are related to implementation of evidence-based treatments: experiences from the SWEDEHEART registry 1995–2014. European Heart Journal, 2017. 38(41): p. 3056-3065.
2 Cahill et al. Heart failure after myocardial infarction in the era of primary percutaneous coronary intervention: Mechanisms, incidence and identification of patients at risk. World J Cardiol. 2017 May 26;9(5), 407-415.
3 Egred, M., et al., Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study. IJC Heart & Vasculature, 2020. 28: p. 100526.
4 De Maria et al. Index of microcirculatory resistance-guided therapy with pressure-controlled intermittent coronary sinus occlusion improves coronary microvascular function and reduces infarct size in patients with ST-elevation myocardial infarction: the Oxford Acute Myocardial Infarction - Pressure-controlled Intermittent Coronary Sinus Occlusion study (OxAMI-PICSO study). EuroIntervention 2018;14(3):e352- e359.
5 Stone et al. Relationship Between Infarct Size and Outcomes Following Primary PCI: Patient-Level Analysis From 10 Randomized Trials. J Am Coll Cardiol. 2016 Apr 12, 67(14), 1674-1683.
