CorFlow Advances Heart Attack Care with Dual Trials and Expert Hires

BAAR, SWITZERLAND – April 30, 2026 – CorFlow Therapeutics, a clinical-stage medical device company, has announced a series of major advancements that position it at the forefront of a critical, underserved area of cardiac care. The Swiss firm has successfully completed the first phase of its pivotal U.S. trial, launched a second major study in Europe, and bolstered its leadership with seasoned industry veterans, signaling a significant acceleration in its mission to transform outcomes for heart attack patients.

These milestones center on tackling microvascular obstruction (MVO), a common and dangerous complication that occurs even after a successful artery-opening procedure. By advancing a unique "diagnose and treat" platform, CorFlow aims to provide interventional cardiologists with the tools to address the full scope of damage caused by a heart attack, potentially setting a new standard of care for a condition that affects hundreds of thousands of patients annually.

The Unseen Enemy After a Heart Attack

When a patient suffers a major heart attack, known as an ST-segment elevation myocardial infarction (STEMI), the immediate priority is to restore blood flow to the heart by reopening the blocked main coronary artery, typically with a stent. While this procedure, called primary percutaneous coronary intervention (PCI), is life-saving, it doesn't always solve the entire problem. In as many as 50-60% of cases, a secondary, more insidious issue arises: microvascular obstruction.

MVO is the blockage of the heart's smallest blood vessels, the capillaries, due to debris, swelling, and inflammation caused by the initial blockage and the subsequent rush of blood upon reperfusion. Though the main "highway" is clear, the "local roads" remain clogged, starving portions of the heart muscle of oxygen. The clinical consequences are severe. MVO is a powerful and independent predictor of future adverse events, including heart failure, repeat heart attacks, and death.

Despite its prevalence and prognostic importance, MVO remains a frustratingly elusive target in the catheterization lab. The current gold standard for diagnosis is a cardiac MRI, which can only be performed days after the initial procedure, long after the critical window for intervention has closed. This diagnostic delay has created a major treatment gap, leaving MVO an "unmet clinical need," as described by the European Society of Cardiology.

A Two-Pronged Clinical Assault on MVO

CorFlow is confronting this challenge with a comprehensive strategy embodied in two landmark clinical trials. The first, MOCA II, is a pivotal study designed to validate its proprietary Pressure Controlled Flow Infusion (PCoFI) diagnostic system. The device, which has already received "Breakthrough Device Designation" from the U.S. Food and Drug Administration (FDA), aims to give cardiologists a fast, accurate MVO diagnosis in real-time during the stenting procedure.

The trial's first phase, involving 19 patients across the U.S. and Europe, successfully met its safety and performance goals, as confirmed by an independent data safety monitoring board. This achievement triggered the launch of Phase 2, which will expand the study to a larger cohort of over 200 patients across nearly 50 top-tier hospitals. The first patients in this new phase were recently enrolled by Professor Marco Valgimigli at the Cardiocentro Ticino Institute in Switzerland.

“I am excited to see the next generation of the CorFlow technology and advancement of the clinical program," stated Professor Valgimigli. "Fast, accurate diagnosis of MVO is the key step we need to build from.”

Running in parallel is the newly approved REVITALISE trial in Europe. This randomized controlled study will evaluate the therapeutic side of CorFlow's platform: the CorFlow Continuous Flow Infusion (CoFI) System. The system is designed not only to diagnose MVO but also to deliver therapeutic agents directly to the affected microvasculature. The trial, set to enroll at least 250 patients, will begin in the UK before expanding to France, the Netherlands, and Spain, with early results expected in 2027. Its adaptive platform design cleverly allows for future testing of additional drug candidates, making it a flexible and forward-looking research tool.

“Between both studies, we will have close to 50 top-tier hospitals engaged, each with a team motivated to see these studies succeed,” said Paul Mead, CEO of CorFlow. “Our technology and clinical studies aim to build on that with a major step forward towards truly complete revascularization.”

Fortifying the Ranks for Market Conquest

To navigate the complex clinical and regulatory landscape, CorFlow has strategically strengthened its leadership team with two high-profile appointments. Dr. Rick Kuntz, a renowned interventional cardiologist and former Chief Medical and Scientific Officer at medical device giant Medtronic, has joined the company’s Board of Directors as an Observer and senior scientific advisor. Dr. Kuntz’s three decades of experience guiding technologies from clinical trials to market clearance at both Medtronic and the Harvard Clinical Research Institute, which he co-founded, provides CorFlow with invaluable strategic insight.

“I personally had the chance to work with Dr. Kuntz at Medtronic for many years and cannot think of a better addition for CorFlow to help guide our strategic, scientific and regulatory path forward for this breakthrough technology,” commented Chris O’Connell, Chairman of the Board of CorFlow.

Complementing this strategic addition is the appointment of Dr. Pedro Eerdmans as Vice President Clinical. Dr. Eerdmans brings decades of hands-on experience in executing clinical studies for medtech companies, including scaling startups and overseeing major coronary stent studies as VP of Medical Affairs at Biosensors International. His expertise will be critical in managing the operational demands of the expansive MOCA II and REVITALISE trials.

Investor Confidence and the Path Forward

CorFlow’s ambitious clinical program is backed by significant financial and investor confidence. In September 2024, the company announced the closing of a €44 million ($48.5 million) Series B financing round co-led by a global syndicate of top-tier medical technology investors, including Broadview Ventures, Panakes Partners, and existing majority shareholder 415 Capital. This substantial funding provides the necessary runway to advance both pivotal trials toward regulatory submission and potential commercialization.

The company is targeting a vast market, with over 420,000 STEMI procedures performed annually in the U.S. and Europe. Given the lack of any currently approved technologies for real-time MVO diagnosis or treatment, a successful outcome for CorFlow's platform could represent a paradigm shift in interventional cardiology. By giving physicians the ability to see and treat the full extent of cardiac damage, the technology promises not just to improve survival rates, but to enhance the long-term quality of life for heart attack survivors, reducing the debilitating burden of heart failure. With its clinical trials underway and its leadership team reinforced, CorFlow is now firmly on a path to address one of the most significant remaining challenges in modern cardiac care.