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.