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DuraGraft is the first and only FDA cleared medical device for use as an intra-operative vascular conduit storage and flushing solution used during CABG surgeries. JUPITER, FL - - October 06, 2023 - Marizyme, Inc. , a global medical technology company focused on the development of products to address unmet clinical needs, today announced that it was granted a de novo from the U.S. Food and Drug Administration for its first in-class product, DuraGraft. DuraGraft is labelled for use as a vascular conduit solution indicated for adult patients undergoing Coronary Artery Bypass Grafting surgeries and is intended for the flushing and storage of the saphenous vein grafts used in CABG surgery. The mechanism of action for DuraGraft is through the reduction of oxidative damage which maintains the structural and functional integrity of vascular conduits. DuraGraft has been studied extensively in clinical studies including imaging studies. These studies show that saphenous vein grafts treated