Delcath Systems, Inc. products

Delcath has developed a percutaneous targeted, whole-organ treatment that delivers a select high-dose chemotherapy agent directly to the liver, while controlling systemic side effects, by filtering the chemotherapeutic agent from the blood before returning it to the patient. In the US, our drug/device investigational product is HEPZATO™ KIT (melphalan hydrochloride for injection/hepatic delivery system). HEPZATO™ has not been approved by the U.S. Food & Drug Administration. It is under evaluation in a global registration trial (FOCUS Trial)  for treatment of patients with hepatic dominant ocular melanoma. In Europe our product is sold under the trade name CHEMOSAT® Hepatic Delivery System (“CHEMOSAT”). CHEMOSAT was CE Marked in 2012, to treat patients with cancers of the liver.