Saturday, October 07, 2023
Marizyme, Inc. a global medical technology firm dedicated to addressing unmet clinical needs, has announced the receipt of a de novo clearance from the U.S. Food and Drug Administration (FDA) for its groundbreaking product, DuraGraft™. DuraGraft, a pioneering vascular conduit solution, is intended for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries. It serves the purpose of flushing and storing saphenous vein grafts utilized in CABG surgery. The product's mode of action revolves around mitigating oxidative damage, thereby preserving the structural and functional integrity of vascular conduits.
Extensive clinical studies, including imaging research, underscore DuraGraft's effectiveness. The results demonstrate that saphenous vein grafts treated with DuraGraft exhibit reduced graft wall thickening compared to standard saline-treated grafts, particularly evident at the 12-month post-CABG surgery mark. Furthermore, the use of DuraGraft is associated with reduced long-term mortality up to three years post-CABG surgery.
Cardiac care is a significant and rapidly expanding industry, with coronary heart disease incurring an estimated average annual cost of $219 billion in the United States, according to the CDC. CABG surgery ranks as the most prevalent form of open-heart surgery in the country, with over 500,000 procedures conducted annually. David Barthel, CEO of Marizyme, envisions DuraGraft as a game-changer in the realm of cardiac care.
With this de novo clearance, DuraGraft becomes the sole FDA-cleared medical product designed for intra-operative vascular conduit storage and flushing during CABG surgeries. It is also the only approved product for this purpose in Europe and other international markets.
DuraGraft holds the distinction of being the only patented product for this application in CABG and other vascular surgeries. The DuraGraft patent portfolio includes granted patents and pending applications across more than 30 countries worldwide, including the United States, Europe, Australia, India, Argentina, South Africa, Mexico, and various Asian nations.
Now that the FDA has granted the de novo clearance, Marizyme, Inc. will shift its focus towards executing a comprehensive strategy for commercialization in the United States, with a particular emphasis on fostering adoption within hospital integrated networks using its dedicated sales force.
David Barthel, CEO of Marizyme, Inc., commented on this significant milestone, stating, "With this significant milestone reached, our company, Marizyme, can now present this breakthrough to cardiac surgeons and their CABG patients. This presents a swiftly expanding market that affords Marizyme the chance to fulfill its mission statement and fundamentally transform the field of cardiac care.