Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on oncology. The Company's principal focus is on the treatment of primary and metastatic liver cancers. The Company�s product Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) is designed to administer high dose chemotherapy to the liver, while controlling the systemic exposure to those agents. In the United States, Melphalan/HDS is considered a combination drug and device product, and is regulated as a drug by the United States Food and Drug Administration (FDA). In Europe, the Company�s system to deliver and filter melphalan hydrochloride is marketed as a device under the trade name Delcath Hepatic CHEMOSAT Delivery System for Melphalan (CHEMOSAT). It has authorization to affix a CE Mark for Generation Two CHEMOSAT. The right to affix the CE Mark allows the Company to market CHEMOSAT in Europe.