Marizyme Announces Approval for DuraGraft® in India
Latest Approval Joins a Growing List of Countries for Commercial Sales in 2021
Jan 14, 2021, 07:33 ET
JUPITER, Fla., Jan. 14, 2021 /PRNewswire/ -- Marizyme, Inc. (OTCQB:MRZM), a publicly traded global biotechnology company developing products to reduce the burden of ischemia-reperfusion injury in tissue grafting, organ transplant, and other surgical indications, announced today that its flagship product DuraGraft® is now registered and licensed for import into India through Marizyme's distribution partner Regency Lifesciences.
India represents the latest market approval for DuraGraft, 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. Currently, DuraGraft is approved in the EU and seven additional countries with more world-wide approvals pending.
Dr. Neil Campbell, Marizyme, Inc. President and CEO, said, "We are excited to receive this approval in India and to be working with Regency Lifesciences to bring the healthcare professionals and patients of India this first in class product. India joins a growing list of countries that will form the basis of our commercial efforts in 2021 for DuraGraft."
Abel Alexander, Regency Lifesciences CEO, said, "This approval and licensure represents a significant step toward providing this novel treatment to the estimated 60,000 Coronary Artery Bypass Graft Surgeries per year."
About CABG and DuraGraft
When patients with heart disease undergo CABG surgery, free vein or arterial grafts harvested from the leg, arm or chest are frequently used to bypass occluded coronary arteries; about 90% of CABG surgeries use at least one free graft. In most cases, in the time between harvesting and bypass grafting, the free graft is stored in saline or autologous blood which do not protect the graft from ischemic injury thereby increasing the risk of ischemia-reperfusion injury and graft disease leading ultimately to graft failure, leading to post-CABG myocardial infarction and the need for repeat revascularization procedures.
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 the period of 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 the reduction of post-CABG complications associated with graft disease and failure: Myocardial Infarction, Repeat Revascularization, and Major Adverse Cardiac Events (MACE).
Clinical studies in more than 3,000 patients support the long-term safety and efficacy of DuraGraft. 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) (Haime et al. 2018). DuraGraft is currently not for sale in the United States.
About Regency Lifesciences
Regency Lifesciences is a Leading Distributor of Healthcare Devices in India. Founded in the year 2001, by a group of highly experienced professionals with a strong background and cumulative experience of more than 37 years in the Indian Health care Industry, and are partnered with some of the world's best manufacturers of medical Devices and supply these products to all major hospitals across India. Regency Lifesciences offer the highest standards of service, making it a paramount objective to serve customers to the greatest of their ability.
About Marizyme, Inc.
Marizyme is an integrated life sciences company dedicated to the acquisition, development and commercialization of therapies that minimize mortality and costs in the acute care space. The company's flagship product, DuraGraft®, is an intra-operative vascular graft storage solution that inhibits endothelial damage and leads to improved clinical outcomes by reducing the incidence of complications associated with vein graft failure in bypass surgery. DuraGraft enhances coronary artery bypass grafting (CABG) surgical outcomes by significantly reducing major adverse cardiac events such as repeat revascularization and myocardial infarction. DuraGraft is approved for use in the EU and several Asian countries but is not yet approved for use in the U.S. Marizyme is also focused on the development and marketing of products based on its clinically tested and previously patented protease-based therapeutic Krillase® platform. Krillase is not approved for use in the U.S. For more information about Marizyme, visit www.marizyme.com.
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SOURCE Marizyme, Inc.
