MariGen™ wound is the second most advanced product in the Kerecis development pipeline. Clinical tests are ongoing and market launch is targeted in Q1, 2012.

Technical Overview

About 34.5 million chronic wounds are treated globally annually. Those are wounds that get stuck in the inflammatory stage of wound healing and do not heal. Chronic wounds are the source of severe emotional and physical stress for patients and create a significant financial burden, both on patients and the whole healthcare system. In the chronic wound the balance between production and degradation of proteins is lost and degradation plays too large a role. The Kerecis MariGen™ Omega3 Extra Cellular Matrix technology provides a unique solution restoring growth factor balance and the healing process

Chronic wounds present an enormous physical, social and economic burden worldwide and their incidence is on the rise with an ageing population. It has been estimated that chronic wounds affect 120 per 100.000 people aged between 45 and 65 years and increases to 800 per 100.000 people aged over 75 year. Chronic wounds result from a number of different causes among them diabetes, pressure, atrial and venous insufficiency, vasculitis and burns. Additional complications, including infections, necrosis, tissue hypoxia, and exudates represent further challenges in dealing with a chronic wound. Poor nutrition, obesity, excessive alcohol consumption and smoking can then add an additional layer of complications to an already serious condition.

Normal wound healing progresses through three stages. The first is Inflammation which lasts 2 to 4 days from the time of injury. Upon injury hemostasis causes vascular constriction, and thrombus formation. Platelets in the wound release factors that recruit neutrophiles and monocytes (macrophages), which in turn attract lymphocytes and fibroblasts to the site of injury. The Proliferatory stage overlaps the inflammatory stage, starts at about day 3 and lasts for several days. It is characterized by angiogenesis, collagen formation and epithelialization mediated by fibroblasts, and is complete when balance is achieved in collagen formation and its continuous breakdown by matrix metalloproteases (MMPs). The Remodeling stage is the third and last stage and can extend over a year or more. Collagen remodeling continues, fibroblasts differentiate into myofibroblasts, vascularity decreases and tissue strength increases.

The corneal portion of the skin. 1. Keratinocytes, 2. Epidermal lipids

Technical Benefits

Chronic wounds fail to progress normally through these stages and arrest at the inflammation stage. In the chronic wound environment factors counteracting healing take control. The concentration of MMPs increases with detrimental effects on collagen formation and remodeling, and other proteins necessary for normal healing. Keratinocyte and fibroblast dysfunction is apparent, and angiogenesis and neovascularization is impaired. Reactive oxygen species, neuropathy and hypoxia also impede healing. This is a vicious cycle that can continue for years on end.

MariGen applied to the wound

The Kerecis MariGen™ Omega3 Extra Cellular Matrix is designed to refocus the healing process of chronic wounds. The matrix acts as a scaffold for revascularization and repopulation by the patient's cells. It is also a substrate for the voracious MMP curbing their appetite for native collagen. The natural lipids in the matrix serve to reduce inflammatory processes thereby allowing wound healing to progress normally. The matrix is ultimately converted into living tissue and remodeling ensues.