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May 18, 2026

CorFlow Advances MOCA II, Launches REVITALISE Trial

KEY TAKEAWAYS

  • CorFlow Therapeutics’s continuous flow infusion (CoFI) system is being evaluated for PCoFI pressure measurement for the detection of microvascular obstruction during PCI.
  • Phase 1 of MOCA II pivotal trial is completed in the United States and Europe.The 
  • REVITALISE randomized clinical trial is approved to start enrolling patients in the United Kingdom, followed by France, the Netherlands, and Spain.

May 18, 2026—CorFlow Therapeutics AG, a Switzerland-based company focused on cardiac care targeting microvascular disease, announced milestones in its MOCA II FDA pivotal trial and REVITALISE trial of the CorFlow continuous flow infusion (CoFI) system, which outputs a novel pressure parameter—PCoFI—for the detection of microvascular obstruction (MVO).

According to CorFlow, phase 1 of the MOCA II trial was successfully reached after safety and performance goals were met. The study aims to validate the threshold value of its diagnostic PCoFI measurement of MVO used during a stenting procedure in patients with ST-segment elevation myocardial infarction (STEMI) when compared to the reference standard diagnosis by cardiac MRI in the subsequent days.

The trial, which comes after the MOCA I first-in-human study, primarily aims to validate the PCoFI measurement for diagnosing MVO in the setting of primary angioplasty compared to cardiac MRI.

CorFlow stated that phase 1 of MOCA II enrolled 19 patients at five sites in the United States and three sites in Europe. The milestone was confirmed by the study’s independent data and safety monitoring board, allowing for phase 2 to begin in a larger wave of clinical trial sites in both the United States and Europe. The first patients in the MOCA II phase II study were enrolled by Professor Marco Valgimigli, MD, at Cardiocentro Ticino Institute in Lugano, Switzerland.

“I am excited to see the next generation of the CorFlow technology and advancement of the clinical program where the international pivotal study is now underway, for which the interventional cardiology community will eagerly await the results,” commented Prof. Valgimigli in CorFlow’s press release. “Once the technology is readily available, it can help drive decision-making in the cath lab to improve our management of STEMI patients. Fast, accurate diagnosis of MVO is the key step we need to build from.”

CorFlow also announced that REVITALISE, its parallel flagship randomized clinical trial, is now approved to start enrolling patients. Enrollment will begin in the United Kingdom with France, the Netherlands, and Spain to follow in the coming weeks.

The company advised that REVITALISE is intended to prospectively test the effectiveness of the CoFI system to deliver therapeutic agents in treating MVO in patients undergoing primary angioplasty for acute MI with STEMI.

The trial intends to enroll at least 250 patients, with early results expected in 2027 and data read-outs expected through 2028. The adaptive platform approach was selected because of its ability to add subsequent arms to the trial, testing the effectiveness of additional drug candidates delivered through the CoFI system. Additional countries and investigational centers are also under evaluation, stated CorFlow.

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