JUPITER, FL – (NewMediaWire) – December 03, 2021 – Marizyme Inc. (MRZM), a biotechnology company engaged in the development and commercialization of products to prevent, treat and diagnose diseases of unmet clinical need announced today 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) Friday, 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 greatest 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.
Dr. Winkler, the PI of the study, reflected on the study results and commented, “After we observed lower troponin values in CABG patients treated with DuraGraft, we conducted a pilot study that we presented at the ICC 2019 resulting in great interest within the community. Based on that data DuraGraft became the standard of care at our hospital. The propensity score-based study we presented today validates and confirms our initial findings across a larger patient base. We are very excited and encouraged to present these results and believe that DuraGraft is a game-changer in treating CABG patients.”
Dr. Emmert commented, “DuraGraft has recently shown promising results in several preclinical studies and clinical investigations to have the potential to protect and preserve vascular conduits from CABG patients. Building on this, the results from the GOAL study are very exciting. They may build the basis for further investigation into the application of DuraGraft for enhanced myocardial protection during on-pump CABG procedures.”
Marizyme is a biotechnology company, based in Jupiter, FL, that is engaged in the research, development and commercialization of technologies and products to prevent, treat and diagnose diseases with unmet clinical need The Company’s flagship product, DuraGraft®, acquired from Somahlution LLC, is an intraoperative vascular graft storage solution that inhibits endothelial damage and leads to improved clinical outcomes by reducing the incidence of complications associated with vein graft failure in bypass surgery. DuraGraft enhances coronary artery bypass grafting (CABG) surgical outcomes by significantly reducing major adverse cardiac events such as repeat revascularization and myocardial infarction. DuraGraft is approved for use in the EU and several Asian countries but is not yet approved for use in the U.S. Marizyme is also focused on the development and marketing of products based on its clinically tested and proprietary protease based therapeutic Krillase® platform. Krillase is not approved for use in the U.S. For more information about Marizyme, visit www.marizyme.com.