Delcath Systems, Inc., is a Delaware corporation incorporated in August 1988. The Company is a pharmaceutical and medical device company focused on oncology. The Company has directed its research efforts towards the development and clinical study of the Delcath chemosaturation system. The Company's proprietary drug/device combination product—Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System is designed to administer high dose chemotherapy to the liver, while controlling the systemic exposure to those agents. The Company operates in one business segment, which is the development and commercialization of the Delcath chemosaturation system. The Delcath chemosaturation system allows the administration of concentrated regional chemotherapy by isolating the circulatory system of the targeted organ. Once the organ is isolated, the Delcath chemosaturation system delivers high doses of chemotherapeutic agents directly to the liver, while limiting systemic exposure and the related side effects by filtering the blood prior to returning it to the patient. The Delcath chemosaturation system involves a series of three catheter insertions, each of which is placed percutaneously through standard interventional radiology techniques. The procedure is minimally invasive and repeatable allowing for multiple courses of treatment with chemotherapeutic drugs and the potential for concomitant cancer therapies. The Company assembles, sterilizes and packages the Delcath chemosaturation system at its facility in Queensbury, New York and has established its European headquarters and distribution facility in Galway, Ireland. It utilizes contract manufacturers to manufacture some components of the Delcath chemosaturation system. The Delcath chemosaturation system competes with all forms of liver cancer treatments. The Delcath chemosaturation system is subject to extensive and rigorous government regulation by foreign regulatory agencies and the FDA.