Delcath Systems, Inc.

https://delcath.com/

Delcath Systems, Inc. is an interventional oncology company dedicated to the treatment of primary and metastatic liver cancers. The company's mission is to deliver therapies that utilize vascular isolation of the liver, focused therapy delivery, and filtration of excess drugs to improve clinical outcomes for patients while minimizing drug-related side effects. Delcath Systems is headquartered in Queensbury, New York.

The company's proprietary product portfolio includes HEPZATO KIT™ (melphalan for Injection/Hepatic Delivery System - HDS) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP). HEPZATO KIT is approved by the FDA in the United States for adult patients with unresectable hepatic-dominant metastatic uveal melanoma. CHEMOSAT is designated under medical device regulation for use in Europe and the United Kingdom. These systems are designed to administer high-dose chemotherapy directly to the liver while controlling systemic exposure and associated side effects.

Gerard Michel serves as the Chief Executive Officer of Delcath Systems. Recent notable developments include the FDA approval of HEPZATO KIT in August 2023, followed by its first commercial use in January 2024. In April 2026, the CHEMOSAT Hepatic Delivery System for Melphalan was included as a recommended liver-directed regional therapy option in the ESMO–EURACAN Clinical Practice Guidelines for Uveal Melanoma, complementing its recognition in NCCN guidelines. The company reported preliminary full-year 2025 revenue of $85.2 million in February 2026 and provided 2026 revenue guidance of at least $100 million.

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CID: 3680