CorFlow Therapeutics AG announced that the U.S. Food & Drug Administration has approved the company's investigational device exemption (IDE) for the MOCA-II pivotal trial, marking a significant milestone in the development of novel diagnostic technology for heart attack patients. The approval enables the Swiss-based company to begin enrolling patients at U.S. hospitals for testing its proprietary CoFl system designed to detect microvascular obstruction during cardiac interventions.
Pivotal Trial Design and Objectives
The MOCA-II study aims to prospectively validate the diagnostic accuracy of CorFlow's CoFl system in determining the presence or absence of microvascular obstruction (MVO) during primary percutaneous coronary intervention (PCI) procedures. The trial's primary endpoint compares the CoFl diagnostic reading to a reference standard of diagnosis by cardiac MRI scan. The study is approved to enroll over 200 STEMI patients at prestigious research institutions across both the United States and Europe.
The trial represents the next critical step following the successful completion of the first-in-human MOCA-I trial in 2024. According to the company, this progression brings the unique technology closer to global deployment among interventional cardiologists for rapid MVO diagnosis in heart attack patients.
Addressing an Unmet Medical Need
The clinical significance of the technology becomes apparent when considering the scope of the problem. According to the Centers for Disease Control and Prevention, someone experiences a heart attack every 30 seconds in the United States, with approximately 800,000 cases reported annually. Incidence and prevalence rates are similarly high in Europe.
More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that the presence of MVO is a major driver of adverse events. Currently, no technologies are approved to diagnose MVO during an acute coronary intervention, and no approved therapeutic devices specifically address MVO in the United States or Europe.
Paul Mead, CEO of CorFlow, emphasized the clinical urgency: "The majority of acute STEMI survivors have MVO, and current outcomes for these patients are shockingly poor. We aim to bring this issue to light and show you can do something about it. This milestone brings us all one step closer to delivering on the promise to improving care for these people where we know we can do better."
Expert Leadership and Clinical Perspective
The MOCA-II trial is being led by world-renowned experts in heart attack care: Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio, and Professor Marco Valgimigli at Cardiocentro Ticino Institute in Lugano, Switzerland. The two investigators have collectively been published in over 1,000 peer-reviewed manuscripts in cardiovascular research.
Dr. Tim Henry expressed enthusiasm for the trial's potential impact: "As an interventional cardiologist involved for decades in managing and researching STEMI patients, I am excited to get going on this pivotal trial with technology that could make such a significant impact to the outcome of our patients. I believe strongly that knowing with high confidence who has MVO at the point of care during a primary PCI procedure can make an immediate difference in how we manage our patients."
Professor Valgimigli, who participated in the MOCA-I first-in-human trial, added: "I am thrilled to see the second-generation technology now available for the pivotal trial and am looking forward to contributing further to the scientific understanding of MVO in real time. While the medical community has diverse opinions on how to treat these patients, there is no question that proper diagnosis is the first step we need."
Technology Platform and Future Applications
The CorFlow technology is designed to serve dual purposes: diagnosing MVO and functioning as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently. This dual capability could potentially enable new treatment pathways for the large MVO patient population that currently experiences high rates of adverse clinical outcomes.
CorFlow Therapeutics, headquartered in Baar, Switzerland, with subsidiary operations in Italy and the United States, is venture capital funded with an international VC firm syndicate. The company completed a Series B financing round in September 2024. The company works in close partnership with scientists from the University of Bern, ETH Zurich, and the University Hospital Zurich, in a collaboration funded by the Swiss Innovation Agency (Innosuisse).
The company's broader mission extends beyond cardiac applications, as it aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow anywhere in the human body where a critical need exists.
