DELCATH SYSTEMS, INC.

Based in New York, Delcath Systems is an interventional oncology company focused on treating primary and metastatic liver cancers. The company develops and commercializes the HEPZATO KIT, a melphalan chemotherapy delivery system designed to administer high-dose chemotherapy directly to the liver while limiting systemic exposure and associated toxicities. The system works through isolated hepatic perfusion, a regional delivery approach intended to maximize therapeutic effect while reducing side effects compared to systemic chemotherapy administration.

Delcath's lead clinical program, the FOCUS trial, is investigating HEPZATO in patients with metastatic hepatic-dominant uveal melanoma. The company also generates revenue in Europe through commercialization of the CHEMOSAT Hepatic Delivery System, a medical device for treating various liver cancers in clinical settings. This product operates as a standalone offering separate from the chemotherapy agent, allowing medical centers to administer melphalan or other chemotherapeutics via the delivery platform.

The company operates across the United States and European markets, with its clinical development activities centered on advancing HEPZATO toward regulatory approval in the U.S. while maintaining commercial operations for CHEMOSAT in established European medical centers. Delcath has maintained operations since its founding in 1987 and remains focused on the interventional oncology space.