Miracor Medical is our second portfolio company to receive Breakthrough Device Designation from the FDA in the last two months

Earlybird is pleased to announce that Miracor Medical, based in Belgium, is our second portfolio company to receive Breakthrough Device Designation by the US Food and Drug Administration (FDA).

This recognition by the FDA of the exceptional potential of these companies will lead to these life-saving technologies being available to patients in an expedited manner. Miracor Medical joins our Ireland-based portfolio company Perfuze in receiving this status.

FDA Breakthrough Device Designation — a program for exceptional medical devices

The FDA regulates medical devices in the USA, assessing their safety and effectiveness. For complex technologies, the process of regulatory approval can take several years as carefully designed clinical trials have to be completed. Since December 2018, the FDA started a new program, the so-called Breakthrough Device Designation, to enable a more efficient approval of medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions[1]. The advantages of being part of the program is a faster, prioritized, more interactive process throughout the standard FDA approval process in which the companies have access to special FDA staff experienced in innovative approaches to regulatory science[2]. It is intended to shorten FDA approval timelines significantly.

Miracor Medical’s PiCSO therapy improves the quality of life of heart attack patients

Following a heart attack, also referred to as myocardial infarction, the heart muscle is partly damaged because of an abnormal cessation of blood flow for a period of time. Worldwide, approximately 15.9 million myocardial infarctions occurred in 2015[3], of which more than 3 million people suffered from a special sub-type called ST elevation myocardial infarction (STEMI)[4]. The standard treatment for STEMI is the restoration of the blood flow to the heart muscle. This is usually achieved by a procedure called percutaneous coronary intervention (PCI), where blood flow is re-established using a balloon and a stent[5].

This is when Miracor Medical’s unique PiCSO therapy can be used to improve patient outcomes. The device is used during PCI and it intermittently blocks blood outflow of the heart, providing the damaged areas with additional blood. This process promotes healing of the injured heart muscle, thus reducing the volume of heart muscle affected by the heart attack.

The reduction of infarction size after STEMI is strongly correlated with reductions in heart failure hospitalizations and reduced mortality[6]. Heart failure occurs in 18–28% of patients within the first 90 days after STEMI[7], which results in a 14% one-year mortality rate after STEMI, despite improvements in clinical practice[8].

In July of this year, Miracor Medical announced the start of its European randomized study, PiCSO-AMI-I, to evaluate the benefits of PiCSO therapy as compared to conventional PCI for the treatment of anterior STEMI patients. To date, the first few patients have been enrolled in this trial.

Earlybird’s strategy of focusing on technologies and treatments that significantly impact patient outcomes is reflected in the second FDA Breakthrough Device Designation in two months.

In addition to Miracor Medical, Perfuze has also received this special status by the FDA. Perfuze is developing next-generation technology to treat acute ischemic stroke.

According to the World Health Organisation, stroke is the second leading global cause of death and a leading cause of disability. An ischemic stroke occurs when a blood vessel in the brain is blocked by a clot, resulting in reduced blood flow (ischemia). Perfuze’s technology aims to provide superior patient-benefit in shorter procedural times, resulting in a safe, cost-effective therapy.

Earlybird views the achievement of FDA Breakthrough Device Designation for two of our portfolio companies as a strong justification of our investment hypothesis, which is to focus on cutting edge technologies that significantly improve the lives of patients whilst also providing efficiencies for the healthcare system.

If you are interested in additional technical information and news on Miracor Medical and Perfuze please visit the links. If you share our vision of bringing patient-outcome focused innovation whilst also improving efficiencies to the healthcare system, please reach out to health@earlybird.com.

[1] https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program

[2] https://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=7329

[3] “Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990–2015: a systematic analysis for the Global Burden of Disease Study 2015”

[4] “Acute myocardial infarction”, Can Med Assoc J. 1972 Jan 8; 106(1): 11–13.

[5] ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force on the management of ST-segment elevation acute myocardial infarction of the European Society of Cardiology (ESC), European Heart Journal, Volume 33, Issue 20, October 2012, Pages 2569–2619, https://doi.org/10.1093/eurheartj/ehs215

[6] 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.

[7] 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.

[8] 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.