The U.S. Food and Drug Administration has okayed CorFlow Therapeutics AG’s (CorFlow) technology for investigational device exemption (IDE), thereby allowing a clinical trial to begin at U.S. hospitals. CorFlow will now prepare these clinical trial sites to receive CorFlow systems, undergo training and begin enrolling patients being treated for heart attacks.

The IDE Pivotal Trial, MOCA-II, aims to prospectively validate the CorFlow CoFl system’s diagnostic accuracy in determining the presence or absence of microvsacular obstruction (MVO) during a primary PCI procedure. The primary endpoint compares the CoFI diagnostic reading to a reference diagnosis standard by a cardiac MRI scan. The trial is approved to enroll more than 200 STEMI patients at U.S. and European research institutions.

“The long history of interventional cardiology and heart attack care breakthroughs—going back over 100 years—is one of the great success stories of medical care progress, but the pioneers and luminaries of the field all agree that the work is unfinished,” CorFlow CEO Paul Mead said. “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.”

Having successfully completed the first-in-human MOCA-I trial in 2024, the MOCA-II study is the next critical step to bringing this technology into the hands of interventional cardiologists globally for rapid MVO diagnosis in heart attack patients. This in turn can enable new treatments and care pathways to the large MVO patient population with high rates of adverse clinical outcomes today. The CorFlow technology is designed to both diagnose MVO, plus serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being researched independently.

According to the U.S. Centers for Disease Control and Prevention, a heart attack occurs every 30 seconds, with about 800,000 cases reported annually in the country. Incidence and prevalence are similarly high in Europe. More than half of STEMI heart attack patients are shown to have MVO, and previous research has demonstrated that MVO presence helps drive adverse events. There are no current technologies approved to diagnose MVO during an acute coronary intervention, and there are no approved therapeutic devices that specifically address MVO in the United States or Europe. Heart attacks and related heart disease remains a leading cause of death and disability worldwide.

MOCA-II is being led by Dr. Timothy Henry at The Christ Hospital in Cincinnati, Ohio and Professor Marco Valgimigli at Cardiocentro Ticino Institute, Lugano (Switzerland), who collectively have been published in more than 1,000 peer-reviewed manuscripts in cardiovascular research.

“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,” Dr. Henry stated. “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.”

“Having played a significant part in MOCA-I first in human trial, 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,” Valgimigli added. “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. I am optimistic that getting the CorFlow technology approved for everyday use by our peer interventional cardiologists can help move the field forward.”

Headquartered in Baar, Switzerland, with subsidiary operations in both Italy and the United States, CorFlow Therapeutics is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced in September 2024. CorFlow 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. Working 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), CorFlow continues to explore applications for its patented technology.