The first MOCA (Microvascular Obstruction with the CoFITM System Assessment) trial is a safety and feasibility trial assessing the CorFlow Controlled Flow Infusion (CoFITM) System. In the first roll-in phase, non-acute (NSTEMI) patients will undergo microvascular obstruction (MVO) diagnosis using CorFlow’s proprietary dynamic Microvascular Resistance (dMVR) sequence. In phase II, dMVR will be measured in acute (STEMI) patients and the peri-procedural measurements will be correlated with post-procedure magnetic resonance imaging (MRI) which will be assessed by an independent MRI corelab. Finally, in Phase III, STEMI patients will be diagnosed using dMVR measurements and treated using intra-coronary CoFITM delivery of tirofiban followed by a final diagnostic sequence. Tirofiban is a small molecule antiplatelet drug belonging to a class of antiplatelet drugs named glycoprotein IIb/IIIa inhibitors. dMVR measurements will again be correlated with post-procedure MRI and evaluated by the independent corelab.
MVO is an independent marker for heart failure and death following acute heart attack (STEMI). An effective MVO diagnostic method and treatment has the potential to markedly reduce late complications following heart attack.
Two patients diagnosed with NSTEMI, underwent standard coronary stenting at the University Hospital of Bern (Inselspital), Switzerland. After successful stent placements, the CorFlow Rapid Exchange CoFITM Catheter was delivered to the stent to measure distal myocardial microvascular resistance. All measurements were successfully completed, without any clinical impact, in less than 2 minutes of coronary artery occlusion during the diagnostic CoFITM sequence. The patients were discharged from Inselspital with no complications.
Prof. Marco Valgimigli, the Principal Investigator of the MOCA I trial, commented: "The CoFI diagnostic sequence is simple and feasible in non-acute heart attack patients. I’m pleased that the system fits our cath lab work flow which will be important when we enter the second phase of the MOCA trial enrolling acute heart attack patients."
The diagnostic CoFITM sequence precisely infuses a crystalloid solution into the coronary microcirculation at a series of flow values. These flows are similar to or lower than resting coronary flow, thus avoiding any non-physiological hemodynamics in the coronary circulation. During the flow infusion, the resulting pressure measurements, using the Opsens OptoWire, enables dMVR assessment quickly and simply. In preclinical studies, the dMVR correlates well with Microvascular Obstruction (MVO) as measured by MRI post procedure.
CorFlow therefore believes that dMVR measurements will be an important diagnostic tool for MVO assessment in real-time during interventional catheter laboratory (cath lab) procedures. This will enable MVO therapy by agent infusion into the microcirculation.
Jon H. Hoem, CorFlow’s CEO and co-Founder, said: "We are very proud to reach this important milestone three years after we founded the company. This progress was made possible by an enormous effort by the CorFlow team, the close cooperation with our investigators, the trusted support from our investors and with the consent of the patients included into the MOCA trial. We look forward to enrolling the remaining patients in the trial."
The MOCA I study will assess important data on the feasibility of detecting, quantifying and treating MVO in acute heart attack patients. Data from this trial will be used for further product development, the CorFlow world-wide regulatory activities and will build the base for further clinical trials.
The MOCA I study is funded by CorFlow and through a public grant which the company has been awarded from Innosuisse, the Swiss Innovation Agency.
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 will 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. It will not be available in Europe, the US or Japan for 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.
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