Het geld zal worden gebruikt voor klinische studies en het opstarten van commercialisering

AWANS, België – (BUSINESS WIRE) – Miracor Medical SA (Miracor Medical) heeft de afsluiting aangekondigd van een 24M € Series-E financieringsronde. De ronde werd geleid door een nieuwe strategische bedrijfsinvesteerder, die werd bijgestaan ​​door mede-investeerder Yonghua. De huidige investeerders Earlybird, Noshaq, Quest for Growth, SFPI-FPIM, SRIW en een andere strategische corporate investeerder ondersteunden ook deze financiering. Het geld zal worden gebruikt om het PiCSO klinische studieprogramma vooruit te helpen, dat tot 750 patiënten zal rekruteren en randomiseren in drie onderzoeken in Europa en de VS. Bovendien start de commercialisering in Europa.

PiCSO-therapie wordt geleverd door interventionele cardiologen tijdens de primaire PCI-procedure (percutane coronaire interventie) bij patiënten met een anterieur ST-verhoogd myocardinfarct (STEMI). Ondanks alle verbeteringen en het wijdverbreide gebruik van reperfusiestrategieën en adjuvante farmacologische therapieën1, is het sterftecijfer na één jaar voor STEMI op 14% gestegen en treedt hartfalen op bij 28% van de patiënten binnen de eerste 90 dagen2. Het PiCSO Impulse-systeem verkleint de grootte van het infarct via zijn unieke werkingsmechanisme, waarbij de uitstroom van de coronaire sinus met tussenpozen wordt afgesloten, waardoor het bloed wordt herverdeeld naar het achtergebleven myocardium en mogelijk leidt tot een verbeterde microvasculaire functie3,4. Het verkleinen van de grootte van het infarct is sterk gecorreleerd met verbetering van ziekenhuisopnames voor hartfalen en verminderde mortaliteit5. Het PiCSO Impulse-systeem heeft in 2019 ‘Breakthrough Designation’ van de FDA en in juni 2020 het CE-keurmerk ontvangen.

Funds will be used for clinical studies and initiation of commercialization

AWANS, Belgium–(BUSINESS WIRE)– Miracor Medical SA (Miracor Medical) has announced the closing of a 24M€ 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 USA. 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% and heart failure occurs in up to 28% of patients within the first 90 days². 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 mortality⁵. The PiCSO Impulse System has received ‘Breakthrough Designation’ from the 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 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% of the technical and clinical research for the product.

About Miracor Medical

Miracor Medical (www.miracormedical.com), located in Awans, Belgium, provides innovative solutions for the treatment of severe cardiac diseases, aiming to improve short and long-term clinical outcomes and reduce associated cost.

Miracor Medical has 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.

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NOTE: The PiCSO^® Impulse System is not approved for use in the United States.

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.

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Contacts

Olivier Delporte

CEO

Miracor Medical SA

odelporte@miracormedical.com