CorFlow’s CoFI System Evaluated in MOCA I First-in-Human Study for Detecting Microvascular Obstruction

May 19, 2023—CorFlow Therapeutics AG, a Switzerland-based developer of the CoFI controlled flow infusion system for diagnostic assessment and therapy delivery for coronary microvascular obstruction (MVO), announced the positive interim results of its MOCA I study. The system outputs a novel pressure parameter—P_CoFI—for the detection of MVO, which was evaluated for correlation with cardiac MRI–measured MVO (considered the reference standard).

The first-in-human MOCA I study aims to evaluate the safety and feasibility of the real-time, catheter-based CoFI system to detect MVO immediately after primary percutaneous coronary intervention (PCI) and deliver timely therapeutic intracoronary agents. The company is continuing to enroll patients in the trial.

The findings from the data set, which included 30 patients with an ST-segment elevation myocardial infarction, were presented by Professor Marco Valgimigli, MD, in a late-breaking trial session at the EuroPCR conference held May 16-19 in Paris, France.

According to the company, the study showed that for patients who had the CoFI diagnostic sequence, the system provided a sensitivity of 95%, specificity of 91%, and an area under the curve of 0.94 for the ability to detect MVO measured by cardiac MRI. The CoFI device and procedure were deemed safe, with no device-related deaths, flow-limiting dissections, or thrombotic events at 30 days, as adjudicated by an independent clinical events committee.

The MOCA I study suggests that accurate, early detection may be possible, which could lead to targeted treatment for these high-risk patients, stated the company.

Professor Valgimigli, who is Deputy Chief of Cardiology at the Cardiocentro Ticino Institute in Lugano, Switzerland, commented in the company’s press release, “Finally, we may be able to detect MVO with confidence, directly at the end of a primary PCI. This is significant. These are important findings that call for further research with this technology.”

Azeem Lati, MD, of Montefiore Medical Center in New York, New York, added, “The data presented from the MOCA I study with the CorFlow system [are] very encouraging for our community of cardiologists, who are increasingly recognizing MVO and microvascular disease as a next frontier to improve outcomes in our field. This emerging area is in its early days, but we can agree that a significant step forward is made by being able to diagnose these patients in the cath lab. With such a technology, we can imagine that many concomitant therapy options can soon be evaluated, since it is now clear that treating only the larger vessels is not enough.”

The CoFI system uses CorFlow’s software algorithms to detect MVO and potentially other conditions related to microvascular function. The system the company plans to bring to market is comprised of a next-generation console, an advanced catheter with a pressure sensor wire, and a single-use infusion cassette. In addition to the primary clinical target of addressing heart attack patients, the company intends to pursue other indications in both coronary and broader vascular use cases with the technology, covered by broad patent families.

CorFlow advised that the CoFI system is not approved in the United States. It is an investigational device limited by federal law to investigational use and is not available for commercial distribution. The company stated it is working toward United States study submissions for clinical trials and commercialization of its technology.