The Company’s one-of-a-kind iron maintenance drug Triferic received FDA approval on January 24, 2015 and commercially launched in the U.S. on September 9, 2015. While the human body needs iron, free iron is toxic and can cause inflammation, infection, oxidative stress, allergic reactions including anaphylaxis, and death. Iron must be bound to a protective shell, called a ligand, for safe transportation within the body. Triferic iron is bound to pyrophosphate, an ideal ligand for iron:
Unlike current nurse IV iron administration, Triferic is seamlessly administered via dialysate directly to the bone marrow, delivering iron in a physiologic manner avoiding iron storage in the liver or reticuloendothelial system. Triferic improves the effectiveness of iron delivery for the majority of dialysis patients and prevents iron induced liver damage, especially for those patients with known concomitant liver disease.
Triferic is a water-soluble iron salt and infused directly to the blood stream, similar to the normal physiologic iron uptake from the ingestion of food. Triferic is formulated for slow, continuous delivery by way of dialysate during every 4-hour dialysis treatment effectively maintaining hemoglobin levels and iron balance without increasing ferritin iron stores. Triferic is formulated to replace the 5-7 mg iron that is lost during every dialysis treatment, providing the body with the iron it needs to form red blood cells and transport oxygen, improving ESA response. Released clinical trial data along with real world usage have shown that small, frequent doses of Triferic, as compared to the current administration of large, infrequent doses of IV iron, is safer and more effective in delivering and maintaining optimal iron balance.