BAAR, Switzerland–(BUSINESS WIRE)–CorFlow Therapeutics AG (“CorFlow”) announced today that Dr. Felice Gragnano, MD, Inselspital, Bern University Hospital, Bern, Switzerland, has presented interim clinical data from the MOCA I Phase 2 clinical trial during the PCR e-Course. The MOCA I study is a first-in-human (FIH) clinical trial to document the safety and feasibility of the CorFlow Controlled Flow Infusion (CoFI™) System in patients with acute heart attack (STEMI).
During his presentation, Dr. Gragnano highlighted the clinical need for a device which can diagnose microvascular obstruction (MVO) while the STEMI patients are still in the cathlab. To date 5 non-STEMI (NSTEMI) and 13 STEMI patients have been enrolled in the Phase 1 and 2 of the MOCA trial, respectively. The presentation documented the findings in the first 5 NSTEMI and 10 STEMI patients. The data from these first 15 patients have been 100% source verified and all adverse events were adjudicated by an independent clinical events committee.
The safety data from these first 15 patients show that the CoFI™ diagnostic procedure is safe and no device-related adverse events occurred in any of the study participants. Specifically, no device related deaths, flow-limiting dissections, nor thromboembolic events were found during the procedure as well as at 30-days follow-up. The presentation also documented a 100% success rate of completing the CoFI™ diagnostic procedure in the first enrolled patients.
The MOCA I study is a non-randomized three-phased FIH clinical trial and the Principal Investigator is Prof. Marco Valgimigli, MD, PhD, Inselspital, Bern University Hospital, Bern / Cardiocentro Ticino, Lugano, Switzerland. Phase 2 of the MOCA I study documents the ability of the CoFI™ System to measure the CorFlow proprietary dynamic Microvascular Resistance (dMVR) parameters in 20 STEMI patients. With the first ten patients enrolled and analyzed, this phase has documented the correlation between periprocedural dMVR values, measured by the CoFI™ System, and perfusion parameters quantified by magnetic resonance imaging (MRI) three days after the revascularization procedure.
Data from the first 10 STEMI patients also show that the CoFI™ diagnostic procedure can differentiate patients with or without MVO in the cathlab. (Read more…) This finding opens the window to diagnose the coronary microcirculation and to monitor treatment effects while the patients are still in the cathlab.
Prof. Javier Escaned, Head of Interventional Cardiology at Hospital Clinico San Carlos, Madrid, Spain, commented: “The MOCA trial provides fascinating new insights into the coronary microcirculation. A diagnostic method for MVO is a potential breakthrough in identifying STEMI patients with higher risk while they are still in the cathlab and this will also be key in setting the indication of specific treatments for microcirculatory injury.”
The CoFI™ (COF-fee) System diagnostic dMVR technology is designed to differentiate patients with and without MVO after stent implantation in patients with acute myocardial infarction (STEMI). This will potentially help cardiologists to better manage STEMI patients in the catheter laboratory (“cathlab”) without changing the established intervention workflow. In patients with substantial microvascular impairment, the CoFI™ System also allows for controlled delivery of intra-coronary therapeutic agents and monitoring the treatment effect before the patients leave the cathlab.
The CoFI™ System has received US Food and Drug Administration (FDA) Breakthrough Device Designation and CorFlow is planning an Early Feasibility Study (EFS) in the US using the first-generation devices.
For complimentary registration and to view Dr. Gragnano’s complete presentation, please register here: https://www.pcronline.com/Courses/PCR-e-Course/Attend. The presentation will be available for replay during and after the PCR e-Course.
About CorFlow Therapeutics AG
CorFlow Therapeutics (www.corflow-therapeutics.ch) is incorporated in Baar, Switzerland, and is developing proprietary technologies to measure the coronary microvascular status and provide therapy to the compromised coronary microcirculation at the same time in the catheter laboratory. Microvascular obstruction (MVO) after an acute heart attack is documented to be an independent marker leading to costly complications such as heart failure. The CorFlow technologies may enable interventional cardiologists to treat MVO in severe heart attack patients thereby potentially reducing the short- and long-term complication rates in these patients.
Caution: The CorFlow Controlled Flow Infusion (CoFITM) technology is in the early phases of development. The CoFITM System is approved for use in the MOCA I clinical trial in Switzerland. It will not be available in other European countries, the US or Japan for other clinical trials until further notice and is NOT available for sale. This news release contains certain “forward-looking” statements under the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of CorFlow are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the protection of intellectual property, changes to governmental regulation of medical devices, European or US Food and Drug Administration (FDA) approvals of new products, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the interventional cardiology industry and the economy and other factors.
Ronald Trahan, APR, Ronald Trahan Associates, +1-508-359-4005, [email protected]