CorFlow Therapeutics Reports Phase 1 Completion, Initiates Phase 2 Enrollment in MOCA II Trial, Gains EU Approval for REVITALISE RCT, and Expands Clinical Leadership
CorFlow Therapeutics AG has announced a series of important clinical and organizational milestones that mark significant progress in its mission to transform the diagnosis and treatment of heart attack patients. The company, which is focused on addressing microvascular complications following acute myocardial infarction, is advancing both its diagnostic and therapeutic platforms through pivotal clinical trials while simultaneously strengthening its leadership team with experienced industry and clinical experts.
Progress in MOCA II Pivotal Trial
A key highlight of the announcement is the successful completion of Phase 1 of the MOCA II FDA pivotal trial. This early phase achieved its predefined safety and performance objectives in patients experiencing ST-segment elevation myocardial infarction (STEMI), a severe and time-sensitive form of heart attack. The trial evaluated CorFlow’s proprietary PCoFI (Pressure-controlled Flow Infusion) diagnostic measurement, which is designed to detect microvascular obstruction (MVO) during a coronary stenting procedure.
Microvascular obstruction is a critical but often underdiagnosed complication that occurs when small blood vessels within the heart remain blocked even after the main coronary artery has been reopened. This condition can significantly impair recovery, increase the risk of heart failure, and worsen long-term outcomes. Traditionally, MVO is diagnosed using cardiac MRI several days after the intervention, limiting its usefulness for immediate clinical decision-making.
CorFlow’s PCoFI technology aims to change this paradigm by enabling real-time detection of MVO directly in the catheterization laboratory. In Phase 1 of MOCA II, the diagnostic performance of PCoFI was compared against cardiac MRI, which remains the gold standard for MVO detection. The study enrolled 19 patients across eight sites, including five in the United States and three in Europe. According to the company, the results demonstrated that the technology met its safety and performance benchmarks, supporting its continued evaluation.
The successful completion of Phase 1 was confirmed by an independent Data and Safety Monitoring Board (DSMB), which reviewed the data and endorsed progression to the next stage of the trial. As a result, CorFlow has now initiated Phase 2 of MOCA II, which will involve a broader network of clinical sites across both the U.S. and Europe. The primary objective of the study is to validate the threshold value of the PCoFI measurement for accurately diagnosing MVO during primary angioplasty procedures.
Expansion into Phase II and Clinical Enthusiasm
The transition into Phase II represents a major step forward for CorFlow’s diagnostic platform. The first patients in this phase have already been enrolled under the leadership of Marco Valgimigli at Cardiocentro Ticino Institute. Professor Valgimigli, a leading figure in interventional cardiology, emphasized the importance of rapid and accurate MVO detection in improving patient outcomes.
He noted that the availability of real-time diagnostic tools like PCoFI could significantly enhance clinical decision-making during procedures, allowing physicians to tailor treatment strategies immediately rather than waiting for delayed imaging results. This capability has the potential to address a longstanding gap in cardiovascular care, where the success of reopening blocked arteries does not always translate into optimal tissue-level perfusion.
The broader interventional cardiology community is closely watching the progress of MOCA II, as it represents one of the first large-scale efforts to validate an intra-procedural diagnostic tool for microvascular dysfunction in heart attack patients.
Launch of REVITALISE Therapeutic Trial
In parallel with its diagnostic program, CorFlow is also advancing a therapeutic approach through its flagship REVITALISE trial. This randomized study has now received regulatory approvals and is set to begin patient enrollment in the United Kingdom, with additional sites planned in France, the Netherlands, and Spain in the near future.
REVITALISE is designed to evaluate the effectiveness of CorFlow’s Continuous Flow Infusion (CoFI) System in delivering therapeutic agents directly to the coronary microcirculation during primary angioplasty. The goal is to treat MVO at the time of intervention, potentially improving outcomes by restoring microvascular blood flow and reducing downstream complications.
The study is expected to enroll at least 250 patients and will use an adaptive platform design. This innovative trial structure allows for the addition of new treatment arms over time, enabling the evaluation of multiple drug candidates within the same study framework. Early results from REVITALISE are anticipated in 2027, with more comprehensive data readouts expected through 2028.
By combining diagnostic and therapeutic capabilities, CorFlow is positioning itself to offer a comprehensive solution for managing microvascular complications in acute myocardial infarction. This integrated approach could represent a significant advancement toward achieving more complete revascularization—a long-standing goal in interventional cardiology.
Growing Clinical Network and Strategic Vision
According to CEO Paul Mead, the company’s clinical programs are gaining strong momentum, supported by growing interest from key opinion leaders (KOLs) and leading research institutions. CorFlow is now collaborating with nearly 50 top-tier hospitals across the United States and Europe, each contributing to the advancement of its clinical studies.
Mead highlighted that interventional cardiology is entering a new phase of innovation, with emerging technologies and therapies offering new opportunities to improve patient care. He expressed confidence that CorFlow’s platform could play a central role in this evolution by addressing both diagnostic and therapeutic gaps in the treatment of heart attack patients.
The company’s strategy focuses not only on validating its technologies through rigorous clinical trials but also on building a strong network of clinical partners who can help accelerate adoption and integration into standard practice.
Strengthening Leadership and Scientific Expertise
In addition to its clinical progress, CorFlow has taken steps to enhance its leadership team. The company announced that Rick Kuntz has joined its Board of Directors as an Observer and senior scientific advisor. Dr. Kuntz is a highly respected figure in the field of interventional cardiology, with decades of experience in clinical research and medical device development.
He previously served as a founder and Chief Scientific Officer of the Harvard Clinical Research Institute and later held the role of Chief Medical and Scientific Officer at Medtronic. During his tenure, he oversaw global clinical research programs, medical affairs, and technology development, contributing to the advancement of numerous cardiovascular innovations.
His expertise is expected to play a key role in guiding CorFlow’s clinical and regulatory strategy as the company moves toward potential commercialization of its technologies.
CorFlow has also appointed Pedro Eerdmans as Vice President of Clinical. Dr. Eerdmans brings extensive experience from across the medical device and clinical research ecosystem, including roles in industry, clinical research organizations, and regulatory bodies. He has previously worked with companies such as Biosensors International, where he led medical affairs and supported multiple coronary stent studies.
His appointment is expected to strengthen CorFlow’s ability to execute complex clinical trials and navigate the regulatory landscape, particularly as the company scales its programs across multiple geographies.
Leadership Perspective and Future Outlook
Chris O’Connell, Chairman of the Board at CorFlow, emphasized the importance of both the clinical milestones and the strengthening of the leadership team. Drawing on his prior experience working with Dr. Kuntz at Medtronic, O’Connell expressed confidence that the addition of seasoned experts would enhance the company’s strategic direction and execution capabilities.
He reiterated that CorFlow’s mission is grounded in advancing medical science to improve patient outcomes, with a focus on establishing a new standard of care for heart attack treatment. The combination of innovative technology, robust clinical evidence, and experienced leadership positions the company to make meaningful contributions to the field of cardiovascular medicine.
CorFlow Therapeutics is entering a pivotal phase of growth, marked by the successful advancement of its MOCA II diagnostic trial, the initiation of the REVITALISE therapeutic study, and the expansion of its clinical and leadership infrastructure. By addressing both the detection and treatment of microvascular obstruction, the company is tackling a critical unmet need in the management of acute myocardial infarction.
As its clinical programs continue to progress and generate data, CorFlow aims to redefine how heart attack patients are diagnosed and treated, ultimately improving outcomes and reducing the long-term burden of cardiovascular disease.
About CorFlow Therapeutics: Founded and headquartered in Switzerland, with subsidiary operations in both Italy and the United States. The company is venture capital funded with an international VC firm syndicate, most recently with a Series B financing round announced first announced in September 2024. CorFlow aspires to be the leader in diagnostic and therapeutic solutions for restoring healthy microvascular blood flow, starting with cardiac applications for heart attack patients. 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 research applications for the unique patented technology with pharmaceutical options and new use cases.
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