CorFlow’s MOCA-II Pivotal Trial Receives FDA IDE Approval

July 10, 2025—CorFlow Therapeutics AG, a Switzerland-based company focusing on cardiac care targeting microvascular disease, recently announced that the FDA has approved an investigational device exemption (IDE) for the CorFlow CoFl system, allowing for commencement of the MOCA-II United States pivotal clinical trial of the technology.

CorFlow advised it will now prepare clinical trial sites to receive CorFlow systems, undergo training, and begin enrolling patients being treated for ST-segment myocardial infarction (STEMI).

According to the company, MOCA-II is intended to prospectively validate the diagnostic accuracy of the CorFlow CoFl system in determining the presence or absence of microvascular obstruction (MVO) during a primary percutaneous coronary intervention (PCI) procedure.

The primary endpoint compares the CoFI diagnostic reading to a reference standard of diagnosis by a cardiac MRI scan. The trial is approved to enroll more than 200 patients with STEMI at centers in the United States and Europe, noted CorFlow.

The company stated that the CorFlow technology is designed to diagnose MVO and to serve as a localized drug delivery system for diagnostic and therapeutic agents, which is being investigated independently. The MOCA-I first-in-human (FIH) trial was completed in 2024.

The MOCA-II pivotal trial is being led by Timothy Henry, MD, from The Christ Hospital in Cincinnati, Ohio, and Professor Marco Valgimigli, MD, from Cardiocentro Ticino Institute in Lugano, Switzerland.

“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,” commented Dr. Henry in the company’s press release. “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.”

Prof. Valgimigli added, “Having played a significant part in MOCA-I FIH 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. 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.”