CorFlow Therapeutics Advances Heart Attack Treatment with Successful Phase 1 Completion and Phase 2 Initiation of MOCA II Pivotal Trial
核心洞察
CorFlow Therapeutics (搜索) successfully completed Phase 1 of its MOCA II FDA Pivotal Trial with 19 STEMI (搜索) patients across 8 sites, meeting safety and performance goals for its proprietary PCoFI (搜索) diagnostic technology.
The company initiated Phase 2 enrollment and received approval to begin the REVITALISE trial, which will test its CoFI System (搜索) for treating microvascular obstruction in at least 250 patients.
CorFlow strengthened its leadership team with the addition of Dr. Rick Kuntz as Board Observer and Dr. Pedro Eerdmans as VP Clinical to guide the clinical program forward.
CorFlow Therapeutics (搜索) AG has achieved significant clinical milestones in its mission to transform heart attack treatment, successfully completing Phase 1 of its MOCA II FDA Pivotal Trial and advancing to Phase 2 enrollment while simultaneously receiving approval for its flagship REVITALISE trial.
MOCA II Trial Advances to Phase 2
The Swiss clinical-stage company met all safety and performance goals in Phase 1 of the MOCA II trial, which enrolled 19 STEMI (搜索) heart attack patients across 5 US and 3 European sites. The study evaluated CorFlow's proprietary PCoFI (搜索) diagnostic measurement for detecting microvascular obstruction (MVO) during stenting procedures, comparing results to the reference standard cardiac MRI diagnosis performed in subsequent days.
The milestone achievement was confirmed by the study's independent Data and Safety Monitoring Board (DSMB), triggering approval for Phase 2 to begin across an expanded network of clinical trial sites in both the US and Europe. Professor Marco Valgimigli at Cardiocentro Ticino Institute in Lugano, Switzerland, enrolled the first patients in the Phase 2 study.
"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," said Professor Valgimigli. "Once the technology is readily available, it can help drive decision-making in the cath lab to improve our management of STEMI (搜索) patients. Fast, accurate diagnosis of MVO is the key step we need to build from."
REVITALISE Trial Receives Approval
Parallel to the MOCA II progress, CorFlow announced approval to begin enrollment in its REVITALISE trial, a novel randomized study designed to test the effectiveness of the proprietary CorFlow Continuous Flow Infusion System (CoFI System (搜索)) for delivering therapeutic agents to treat MVO in patients undergoing primary angioplasty for acute ST-elevation myocardial infarction.
The trial will begin enrollment across the UK, with France, Netherlands, and Spain following in the coming weeks. REVITALISE aims to enroll at least 250 patients, with early results expected in 2027 and data read-outs continuing through 2028. The study employs an adaptive platform approach that allows for the addition of subsequent trial arms to test the effectiveness of additional drug candidates delivered through the CorFlow system.
Clinical Program Expansion
Paul Mead, CEO of CorFlow, highlighted the scope of the company's clinical efforts: "With the momentum for our expanded clinical program and high interest from KOLs, we are now fortunate to be partnering with many of the top research institutions and physicians in the US and Europe to help bring the technology forward. Between both studies, we will have close to 50 top-tier hospitals engaged, each with a team motivated to see these studies succeed."
Mead emphasized the potential impact on interventional cardiology: "Our technology and clinical studies aim to build on that with a major step forward towards truly complete revascularization, including superior diagnosis and treatment options."
Leadership Strengthening
CorFlow has bolstered its clinical leadership with two key appointments. Dr. Rick Kuntz, a renowned interventional cardiologist and former Chief Medical and Scientific Officer at Medtronic, joined the Board of Directors as an Observer and senior scientific advisor. Dr. Kuntz was a founder and Chief Scientific Officer of the Harvard Clinical Research Institute (搜索) and brings over 30 years of experience guiding clinical programs through market clearance and post-market research.
The company also appointed Dr. Pedro Eerdmans as Vice President Clinical. Dr. Eerdmans brings decades of experience from industry, clinical research organizations, and notified bodies, including previous roles scaling medtech startups and serving as VP Medical Affairs at Biosensors International (搜索), where he oversaw multiple coronary artery stent studies.
Chris O'Connell, Chairman of the Board, commented on the appointments: "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."
Technology Focus
CorFlow's technology addresses microvascular obstruction, a critical complication in heart attack patients that can occur despite successful primary angioplasty. The MOCA II trial primarily aims to validate the threshold value of the proprietary PCoFI (搜索) measurement for diagnosing MVO in the setting of primary angioplasty compared to cardiac MRI, following the company's first-in-human MOCA I study.
The company, founded and headquartered in Switzerland with subsidiary operations in Italy and the United States, completed a Series B financing round in September 2024. CorFlow works in partnership with scientists from the University of Bern, ETH Zurich, and the University Hospital Zurich through a collaboration funded by the Swiss Innovation Agency (Innosuisse).