Delcath Systems, Inc. (Delcath) is a development-stage company that has developed a device designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body. The Company focused its efforts on the development of a single product, the Delcath PHP System, for the treatment of tumors of the liver. The Company’s Phase III trial is in the final testing stage to support the United States Food and Drug Administration (FDA) approval process. However, the Delcath System is not approved for marketing by the FDA, and it cannot be marketed in the United States without FDA pre-market approval. The Company is also conducting Phase II clinical trials, testing the Delcath PHP System with the drug melphalan against hepatocellular tumors (primary liver cancer) and neuroendocrine and adenocarcinoma tumors that have spread to the liver, as well as melanomas metastatic to the liver that have received certain prior regional treatment.