Marizyme Inc. Announces Results of GOAL Study Presented at 7th Annual International Coronary Congress
December 04, 2021 at 03:00 am IST
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Marizyme Inc. announced that results of the GOAL Study (Vienna Heart Center Floridsdorf/PI Dr. Winkler Bernhard) were presented by Dr. Maximillian Y. Emmert (German Heart Center and Charite Universitatsmedizin, Berlin Germany) December 3 at the 7th Annual International Coronary Congress in New York City. The GOAL Study is an independent investigator observational clinical study to assess the role of vascular graft /storage solutions on myocardial protection during coronary artery bypass grafting (CABG) surgeries. The study was conducted at the Vienna Heart Center Floridsdorf and the Karl Landsteiner Institute for Cardio-Vascular Research, Vienna, Austria under the direction of principal investigator, Dr. Bernhard Winkler. The study was comprised of two cohorts, each cohort consisting of 83 propensity-matched patients undergoing ?on-pump? CABG surgery. Patients in the first cohort received DuraGraft? Vascular Conduit Solution (Somahlution LLC, Jupiter, FL) both for storage of venous and arterial free conduits prior to surgical anastomosis and as a flushing solution down the grafts to check the integrity of the distal anastomosis. Patients in the second cohort received Standard of Care, 0.9% Saline/Biseko (Biotest Pharma GmbH, Dreiech, Germany). In this study, the use of DuraGraft Solution was found to be associated with statistically significant reductions in perioperative high-sensitivity Troponin-I levels beginning at day 1 and persisting through day 6 post-CABG surgery. Peak levels of hs troponin-I were also substantially reduced in patients receiving DuraGraft, with the difference noted at 12-24 hours post CABG surgery. Troponin-I is a marker of ischemic myocardial damage and significantly lower troponin levels suggest that perfusion of the distal vascular beds and downstream myocardium following flushing with DuraGraft confers enhanced myocardial protection compared to standard of care. Repeated flushing of the graft preservation solution down the vascular conduits to test the distal anastomosis was demonstrated to be safe. Clinical data has previously shown the benefit of DuraGraft solution on vascular grafts, but this study is the first that demonstrates DuraGraft can potentially protect the myocardium during CABG surgery, likely through prevention of ischemic injury. Further studies are warranted to correlate the findings with longer term clinical outcomes and to further assess the myocardial protective properties of DuraGraft.
Marizyme, Inc. is a medical technology company. The Company is focused on cardiac and surgical care by delivering innovative solutions for coronary artery bypass graft (CABG) surgery and other surgical procedures. Its product DuraGraft, is a one-time intraoperative vascular graft treatment for use in vascular and bypass surgeries that maintains endothelial function and structure, thereby reducing the incidence and complications of graft failure and improving clinical outcomes post bypass surgery. The Companyâs product under development includes MATLOC and MAR-FG-001. MATLOC is a lab-on-chip digital screening and diagnostic device platform being developed for quantitative chronic kidney disease (CKD) assessment. The MAR-FG-001 is a tumescent solution base for fat grafting procedures that is used for plastic and cosmetic surgeries in which fat is transferred from one area of the body to another to correct a defect, replace injured tissue, or to make cosmetic enhancements.