Of approximately 10 million surgeries that take place in the United States each year, over 2.5 million of them involve blood transfusions. More than 3.7 million patients received at least one unit of transfused blood. The phases III clinical trials of some of the first-generation product are near completion. The regulatory approval would possibly be based on significant elimination of allogeneic transfusion in surgical patients. However demonstrating reduction in mortality and morbidity remains elusive.
Product safety remains a major concern.
HemoZyme SynZyme expects that HemoZyme will capture of the blood substitute market. As a vasodilator with anti-oxidant and inflammatory activities, HemoZyme is expected to emerge as a new generation of blood substitute not only in surgical application but also in the reduction of mortality and morbidity in hemorrhagic trauma. The first indication to pursue will be the elimination of allogeneic transfusion in surgical patients. These strategies could minimize the vasoconstriction and toxicity originated from NO binding. HemoZyme's antioxidant enzyme mimetic activity protects it against auto-oxidation, leading to increased stability in vivo and decreased release of toxic heme and iron.