DuraGraft Approved for US Markets
Key milestone in FDA approval. On October 6, Marizyme, Inc. (MRZM) announced a key milestone in its growth strategy, with FDA approval of its flagship DuraGraft (DG) technology for the US market. Improved outcomes when used in cardiac care. DG has been proven to result in significantly improved outcomes and lower costs for cardiac surgery through multiple clinical trials as well as utilization in selected markets in Europe and Asia where adoption has recently accelerated. Reflecting that, YTD DG-driven revenue is already more than double the level of 2022. Now poised for US commercialization. With FDA approval, the company will begin commercialization of DG in the US, where initial implementation is targeted to strategic partnerships with selected large hospital systems. Marizyme expects annual revenue of $25 million by 2026. The revised near-term outlook, including from the initial launch in the US and further expansion overseas, is for revenue to reach at least $25 million by 2026. Potential US revenue of $300-400 million from DG. The annual revenue potential for DG under its current application in the US is in the $300-400 million range based on about 500,000 coronary artery bypass graft (CABG) procedures per year. Meanwhile, the global potential reflects worldwide annual CABG procedure volumes approaching 1.5 million. Further innovations in DG technology underway. In addition to its current application, further innovation of DG is underway to advance its technology, such as to allow storage and distribution at room temperature and make it available in power formulation. Beyond that, the company is working toward utilization of DG technology in modalities beyond cardiac care such as organ transplantation and fat grafting. See our recent podcast with MRZM CEO. Please refer to the replay of our Water Tower Hour podcast from September 20 when we hosted MRZM CEO David Barthel to provide a company overview and answer our questions about the technology, near-term goals, and risks. The podcast replay is available on our website. The link is in our full report accessible below. Growth upside potential from multiple technologies. As background, MRZM is a fast-growing biomedical company with a multi-technology platform. In addition to DG and its potential applications, other products include MATLOC and Krillase, which are developed but not yet approved for sale.
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