BAAR, Switzerland--(BUSINESS WIRE)--CorFlow Therapeutics AG ("CorFlow") announces today that Dr. Felice Gragnano, MD, Inselspital, Bern University Hospital, Bern, Switzerland, will present a case study and the initial diagnostic results from the MOCA I Phase 2 clinical trial during the upcoming PCR e-Course June 25-27th, 2020. 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). Dr. Gragnano's case presentation will take place during the Clinical Cases session on Thursday, June 25th at 16:00 CET. On Saturday, June 27th at 9:00 CET, Dr. Gragnano will present the initial diagnostic data during a hot line late-breaking trial session.
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. The MOCA I Phase 1 aimed at investigating the diagnostic feasibility in up to 18 patients with non-STEMI (NSTEMI) heart attack. Phase 2 documents the ability of the CoFI™ System to measure the CorFlow proprietary dynamic Microvascular Resistance (dMVR) parameters in 20 STEMI patients. This phase investigates the correlation between periprocedural dMVR values, measured by the CoFI™ System, and microvascular obstruction (MVO) quantified by magnetic resonance imaging (MRI) three days after the revascularization procedure. Finally, Phase 3 will investigate the CoFI™ System's ability to be a treatment platform for safe intra-coronary delivery of therapeutic agents in 20 additional STEMI patients.
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.
Presentations of the MOCA I case study and initial diagnostic clinical data by Dr. Felice Gragnano:
Thursday June 25th @ 16:00 CET during the PCR e-Course virtual meeting, Clinical Case Session, "MOCA I Study: microvascular obstruction measured using dMVR - Case presentation"
Saturday June 27th @ 09:00 CET during the PCR e-Course virtual meeting, Hot Line Late-Breaking Trial Session, STEMI interventions. First-in-Man and novel pharmacological strategies "Dynamic Microvascular Resistance for measuring MVO treatment (MOCA I)"
For complimentary registration and to participate in the PCR e-Course, please click https://www.pcronline.com/Courses/PCR-e-Course/Attend
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.