Qualigen Therapeutics, Marizyme enter co-development agreement for DuraGraft

Marizyme announced a Co-Development Agreement with Qualigen Therapeutics to advance the commercialization of Marizyme’s first-in-class FDA cleared product, DuraGraft. DuraGraft was granted a De Novo – FDA Clearance on October 4, 2023, from the U.S. Food and Drug Administration. DuraGraft is labeled 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. According to the Society of Thoracic Surgeons, there are over 500,000 CABG procedures performed annually in the U.S., representing a major market for this commercial-ready product. Pursuant to the Agreement, Qualigen will help support the commercial launch in the United States of DuraGraft, including post-clearance clinical studies to advance the use of DuraGraft in the U.S., by providing up to $1.5 million in funding over the next several months for these purposes. In return, Qualigen will receive a share of Marizyme’s gross profit on future U.S. sales of the product, capped at a 2X return on Qualigen’s invested capital. Qualigen has also purchased an exclusive negotiation period ending May 31, 2024, for purposes of proposing and outlining a broader strategic relationship between the two companies