Somahlution

Somahlution is a United States-based medical technology company headquartered in Jupiter, Florida, focused on cardiac surgical care. The company is now known commercially as Marizyme, and its flagship offering is DuraGraft, a vascular conduit solution used during coronary artery bypass grafting (CABG) surgery. DuraGraft is positioned as the first and only FDA De Novo-granted solution for the flushing and storage of saphenous vein grafts during CABG, a step in the procedure that has historically lacked a purpose-built, FDA-indicated standard of care. The clinical problem Somahlution/Marizyme addresses is the intraoperative window between vein graft harvest and restoration of blood flow. During this period, grafts are commonly stored in heparinized saline or autologous blood, neither of which is FDA-indicated, quality-controlled, or specifically formulated for vein graft flushing and storage. According to the company, this can trigger acute ischemic injury, endothelial cell damage, and elevated oxidative stress, contributing to early graft thrombosis and late graft disease. DuraGraft is designed to flush and store the graft at room temperature for up to four hours, maintaining graft cell viability and structural integrity through that window. DuraGraft received FDA De Novo classification as a Class II device, a designation reserved for devices with no prior market equivalent. The company states that more than 10,000 procedures have been performed globally using DuraGraft, and it cites a vein graft failure rate of 25.2% at 12–18 months as part of the unmet need it targets. It also notes that more than 200,000 CABG procedures are performed annually in the United States. Strategically, Somahlution/Marizyme describes a patent portfolio spanning more than 30 countries and national network agreements, aiming to provide hospital systems with a tool that supports graft quality during CABG. The company markets to surgeons and health systems, offering clinical evidence, evaluation requests, and Value Analysis Committee documentation. Its mission is to safeguard patient outcomes through maintenance of vascular integrity using a proprietary platform designed to address oxidative damage during the intraoperative window.

Somahlution is a United States medical technology company based in Jupiter, Florida. It is now commercially associated with the name Marizyme, under which its flagship product DuraGraft is marketed. The company was built around a single critical moment in cardiac surgery: the intraoperative window during coronary artery bypass grafting (CABG) when a harvested saphenous vein graft is stored before blood flow is restored. Historically, there has been no standard of care for this window. Surgeons commonly use heparinized saline or autologous blood, but neither is FDA-indicated, quality-controlled, or specifically formulated for vein graft flushing and storage during CABG. Somahlution developed DuraGraft as a purpose-built solution to address this gap. DuraGraft is used to flush and store the graft at room temperature for up to four hours, with the goal of maintaining graft cell viability and structural integrity through the intraoperative window. The company states that the lack of blood flow during storage in non-physiological solutions such as saline triggers acute ischemic injury, endothelial cell damage, and elevated oxidative stress, which are described as the main causes of early graft thrombosis and late graft disease. A major regulatory milestone was the FDA's granting of De Novo classification (Class II) for DuraGraft. This classification is reserved for devices with no prior market equivalent, making DuraGraft the first device classification of its kind for intraoperative saphenous vein graft flushing and storage. The company reports that more than 10,000 procedures have been performed globally using DuraGraft, and it cites more than 200,000 CABG procedures performed annually in the United States, along with a 25.2% vein graft failure rate at 12–18 months, as evidence of the unmet need. Strategically, Somahlution/Marizyme describes a patent portfolio spanning more than 30 countries and national network agreements, positioning itself for long-term sustainability. The company markets to surgeons and hospital systems, offering clinical evidence, evaluation requests, and Value Analysis Committee documentation. Its stated mission is to redefine the standard of cardiac surgical care by safeguarding patient outcomes through the maintenance of vascular integrity, using a proprietary platform designed to address oxidative damage during the intraoperative window.

• FDA grants DuraGraft De Novo classification (Class II), the first device classification of its kind for intraoperative saphenous vein graft flushing and storage.

• DuraGraft surpasses 10,000 procedures performed globally.

First-in-class, FDA De Novo-granted vascular conduit solution for intraoperative saphenous vein graft flushing and storage during CABG surgery.

• DuraGraft Vascular Conduit Solution

  The first and only FDA De Novo-granted solution for the flushing and storage of saphenous vein grafts during coronary artery bypass grafting (CABG) surgery. Used to flush and store the graft at room temperature for up to 4 hours, maintaining graft cell viability and structural integrity through the intraoperative window.

1. 1DuraGraft Vascular Conduit Solution for CABG | Marizymemarizyme.com
2. 2About Marizyme | Medical Technology for Cardiac Surgerymarizyme.com
3. 3Somahlution (United States) - Wikidatawikidata.org
4. 4Marizyme Announces New Distribution and Channel Partnership for Chilean Market with Abderaprnewswire.com
5. 5Marizyme, Inc. Completes Acquisition of Somahlution, Inc. and Raises $7.0 Million in Private Placementfinanznachrichten.de