A pioneer in cardiac treatment for microvascular disease, today announced that the U.S. Food & Drug Administration (FDA) has granted its technology an Investigational Use Exemption (IDE), allowing the pivotal clinical trial to begin in U.S. hospitals. CorFlow will now prepare clinical trial sites for the rollout of the CorFlow systems, conduct training, and begin recruiting patients being treated for a heart attack.
The IDE pivotal MOCA-II study is designed to prospectively validate the diagnostic accuracy of the proprietary CorFlow CoFl System in determining the presence or absence of microvascular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the diagnostic CoFl measurement to a reference standard determined by cardiac MRI. The study is approved to enroll over 200 STEMI patients at renowned research institutions in the United States and Europe.
Following the successful completion of the first-in-human MOCA-I study in 2024, the MOCA-II study is the next important step in making this unique technology available to interventional cardiologists worldwide for the rapid diagnosis of MVO in heart attack patients. This, in turn, may enable new treatment and care pathways for the large MVO patient population, which currently has high rates of adverse clinical outcomes. The CorFlow technology serves both as a diagnostic and local delivery system for diagnostics and therapeutics, and is currently being independently researched.
According to the U.S. Centers for Disease Control and Prevention, someone in the United States has a heart attack every 30 seconds, with approximately 800,000 cases reported annually. In Europe, the incidence and prevalence are similarly high. More than half of STEMI heart attack patients have MVO, and previous research has shown that the presence of MVO is a significant factor in adverse events. Currently, there are no approved technologies in the United States or Europe to diagnose MVO during acute coronary intervention, and no approved therapeutic devices specifically targeting MVO. Heart attacks and related heart disease remain a leading cause of death and disability worldwide.
Paul Mead, CEO of CorFlow, said: “The long history of interventional cardiology and breakthroughs in heart attack care—dating back over 100 years—is one of the great success stories of medical progress, but the pioneers and luminaries in the field agree that the work is still to be done. The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We want to bring this problem to light and show that something can be done. This milestone brings us all one step closer to improving the care of these people where we know we can make a difference.”
MOCA-II is led by world-renowned experts in heart attack care, Dr. Timothy Henry of Christ Hospital in Cincinnati, Ohio (USA), and Professor Marco Valgimigli of the Cardiocentro Ticino Institute in Lugano (Switzerland), who together have published over 1,000 peer-reviewed manuscripts in cardiovascular research.
Dr. Tim Henry said: “As an interventional cardiologist with decades of experience treating and researching STEMI patients, I am very excited about this pivotal study using a technology that could have such a significant impact on our patients’ outcomes. I firmly believe that the reliable detection of MVO at the point of care during a primary PCI procedure can make an immediate difference in the treatment of our patients.” Professor Valgimigli added: “Having been heavily involved in the first-in-human MOCA-I trial, I am delighted that the second-generation technology is now available for the pivotal study and look forward to making a further contribution to the scientific understanding of MVO in real time. While there are differing opinions within the medical community regarding how to treat these patients, there is no question that a correct diagnosis is the first step we need. I am optimistic that the approval of CorFlow technology for daily use by our interventional cardiologists can help advance this field.”
About CorFlow Therapeutics: The company is headquartered in Baar, Switzerland, with offices in Italy and the United States. The company is funded by an international consortium of venture capitalists, most recently through a Series B financing round announced in September 2024. CorFlow aims to establish a leading position in diagnostic and therapeutic solutions to restore healthy microvascular blood flow to all critically needed sites throughout the human body. In close collaboration with scientists at the University of Bern, ETH Zurich, and the University Hospital of Zurich, and with financial support from the Swiss Innovation Agency (Innosuisse), CorFlow continues to explore potential applications for its unique patented technology.
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