DCTH

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The Company's products, HEPZATO KIT (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT Hepatic Delivery System for Melphalan (CHEMOSAT) percutaneous hepatic perfusion (PHP) are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure. HEPZATO KIT is a drug/device combination product designed to administer high-dose chemotherapy directly into the liver while limiting systemic exposure and associated side effects. In Europe, the hepatic delivery system is a stand-alone medical device having the same device components as HEPZATO KIT, but without the melphalan hydrochloride and is approved for sale under the trade name CHEMOSAT. In the United States, HEPZATO is regulated as a drug by the United States Food and Drug Administration (FDA).