Products & Pipeline

DuraGraft®

  • DuraGraft is a one-time intraoperative vascular graft treatment that improves clinical outcomes by reducing the incidence and complications of graft failure.
  • DuraGraft enhances coronary artery bypass grafting (CABG) surgical outcomes by protecting endothelial cells from ischemic damage and reperfusion injury, thereby reducing major adverse cardiac events such as repeat revascularization and myocardial infarction.
  • DuraGraft is clinically proven to reduce complications associated with Vein Graft Failure (VGF) post-CABG.

 

Marizyme acquired DuraGraft through the 2019 purchase of Somahlution assets.

Problem:

 

 

  • Intraoperative Graft Damage is the principal cause of Vein Graft Failure (VGF). The durability and patency of vein grafts are significantly compromised by Vein Graft Disease (VGD):
    • The VGD process begins with endothelial damage that occurs during the grafting surgery itself.
    • VGD encompasses the pathophysiological changes that occur in vein grafts following their use in surgical grafting.
  • Endothelial Damage, manifested within minutes as pro-inflammatory and pro-thrombogenic changes within the graft, leads to VGD and VGF.
  • As VGD progresses, vein grafts lose their ability to adapt to the post-grafting environment, leading to:
    • Thrombus formation
    • Intimal hyperplasia
    • Atherosclerosis
    • These may result in:
      • Graft stenosis
      • Occlusion
      • Loss of graft patency
  • VGD that progresses to VGF may result in myocardial infarction and the need for repeat revascularization. The success rate of revascularization or re-intervention of a failed graft is very poor. Therefore, addressing early vein graft disease in the primary graft is crucial.

Solution:

Duragraft is designed for tissue preservation

 

  • DuraGraft® is an intraoperative vascular graft treatment that maintains endothelial cell function and structure, reducing the incidence and complications associated with graft failure, thereby improving clinical outcomes.
  • DuraGraft improves clinical outcomes by providing a pH balanced and buffered environment which protects against intraoperative Ischemic Reperfusion Injury (IRI).
  • DuraGraft is:
    • pH balanced – Heparinized saline and autologous blood are not pH balanced.
    • Ionically balanced – Critical in maintaining cell osmolarity and membrane integrity.
    • Formulated to support the viability and health of the graft post-grafting – L-Arginine is included to support synthesis of nitric oxide during the ischemic period.
  • DuraGraft also protects against the two main causes of IRI – oxidative damage and metabolic stress.
    • Stabilized antioxidants – Two potent antioxidants (glutathione and ascorbic acid) neutralize the reactive oxygen species that cause oxidative damage during ischemia.
    • Supports anaerobic metabolism – Contains components (glucose and high energy phosphates) that support anaerobic metabolism during ischemia, thereby preventing the generation of metabolic stress lesions,
  • DuraGraft is clinically tested and approved for use, outside the U.S., for maintaining free arterial and venous vascular grafts.
    • DuraGraft has been proven to reduce clinical complications (MI, Repeat Revascularization and MACE) associated with VGF, with statistical significance.

Krillase®

Krillase®, a previously patented protease-based therapeutic, is a naturally occurring enzyme extract that acts to break protein bonds and has potential applications in dental care, wound healing and thrombolysis.

 

Acquired by Marizyme from Swedish company ACB Holding AB, Krillase received medical device status in the European Union for debridement of deep partial and full-thickness wounds in hospitalized patients on July 19, 2005. Marizyme is currently investigating if a medical device status is still accepted as the Medical Device Directive was updated in 2007 and the new Medical Device Regulation becomes effective in 2021. Krillase is not yet approved for use in the EU or U.S.

 

Krillase activity is unique – it is the only enzymatic product based on a co-operative multi-enzyme system involving both endo- and exopeptidases.

 

The proteolytic enzymes of Krillase are composed of eight natural enzymes acting in a synergetic manner, including:

  • Three serine proteinases with trypsin-like activity (one endo/exopeptidases, two endopeptidase),
  • One serine proteinase with chymotrypsin-like activity, and
  • Four exopeptidases (two carboxypeptidases A and two carboxypeptidases B).

 

Krill enzymes are also unique in that they are mutually protected against the degrading effect of each other and they act in a two-step fashion when breaking down proteinaceous substrates.

  • First, endopeptidases attack peptide bonds of the infrastructural parts of the polypeptide chains.
  • The resulting peptide fragments are subsequently cleaved by exopeptidases into small peptides and free amino acids.

 

Marizyme currently has four product candidates derived from Krillase.

  • MB101 to debride and heal human wounds
    • MB101 was tested in multiple clinical stage studies conducted by ACB Holding AB prior to its acquisition by Marizyme.
      • In these studies, which were designed as Phase II efficacy studies and conducted in several European countries, patients were treated for wound debridement and healing.
      • No clinical trials of MB101 have been conducted in the United States.
  • MB102 for acute cerebral ischemic stroke
  • MB104 to treat deep vein thrombosis
  • MB105 to dissolve plaque and biofilms on teeth