DuraGraft Receives SGK National Reimbursement in Turkey
DuraGraft a one-time intraoperative treatment used during vascular surgery to reduce the incidence of complications associated with graft failure
JUPITER, FL – February 18, 2020 – Marizyme’s (OTCQB:MRZM) distribution partner, Somahlution, a global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, today announced that it received National Reimbursement from Turkey’s Social Security Administration, SGK, for its flagship product DuraGraft. Marizyme expects to acquire all of the assets of Somahlutions and expand the distribution of DuraGraft.
DuraGraft is a CE-marked product that protects vascular grafts against ischemic injury and is the only product approved for graft protection and preservation during bypass and other vascular surgeries. DuraGraft protects graft tissue from harvesting through anastomosis and is used during vascular surgery (including CABG) as a treatment to maintain the structural and functional integrity of isolated vascular grafts. The use of DuraGraft is associated with reduction of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization and MACE.
The use of DuraGraft to protect grafts was shown to be a cost-effective option for the Turkish Social Security Institute (SSI)i. Approximately 50,000 Turkish patients have CABG surgery each year. Turkish reimbursement now covers the cost of DuraGraft use in CABG surgery for all Turkish public hospitals in select patient populations. This population includes patients receiving vein grafts, patients on antilipidemic medication, insulin dependent diabetics, patients having repeat CABG surgery and Chronic Kidney Failure patients on dialysis.
“DuraGraft protects grafts from ischemic damage during CABG surgery and is a simple step a surgeon can take to help prevent post-CABG complications associated with graft disease and failure,” notes Dr. Huseyin Okutan of Medical Park Antalya Hospital. “DuraGraft is simple to use and doesn’t change my surgical practice. National reimbursement for DuraGraft makes it easier for Turkish cardiothoracic surgeons to provide their patients with greater access to this enhanced technology to help provide better outcomes following CABG.”
Clinical studies in over 3,000 patients support the long-term safety and efficacy of DuraGraft compared to unapproved standard of care solutions. The use of DuraGraft in CABG surgery is associated with statistically significant lower risks for clinical complications following CABG; 45% reduction in non-fatal myocardial infarction (MI) (p <.0001), 35% reduction in repeat revascularization (p=0.037), and 19% reduction of MACE (a composite of all major adverse cardiac events) (p=0.005). ii
Somahlution is a global leader in the development of products to reduce the burden of ischemia- reperfusion injury in tissue grafting, organ transplant, and other surgical indications. The company’s flagship product, DuraGraft, is a vascular graft treatment that improves clinical outcomes by reducing the incidence of complications associated with graft failure. DuraGraft enhances CABG surgical outcomes by significantly reducing major cardiac events such as repeat revascularization and myocardial infarction.
For more information about the company, please visit www.somahlution.com
Karen Coviello, 561-433-6630 Marketing Communications Karen.Coviello@Somahlution.com
i Tatar, M et al. (2017) Cost Effectiveness Of Duragraft As A Vein Graft Treatment In Coronary Artery Bypass Grafting In Turkey,
Value in Health, Volume 20, Issue 9, A587, DOI: https://doi.org/10.1016/j.jval.2017.08.1068
ii Miguel Haime, Robert R. McLean, Katherine E. Kurgansky, Maximilian Y. Emmert, Nicole Kosik, Constance Nelson, Michael J. Gaziano, Kelly Cho & David R. Gagnon (2018) Relationship between intra-operative vein graft treatment with DuraGraft® or saline and clinical outcomes after coronary artery bypass grafting, Expert Review of Cardiovascular Therapy, 16:12, 963-
970, DOI: 10.1080/14779072.2018.1532289