Delcath Systems is an interventional oncology company with a single commercial product: the HEPZATO KIT in the U.S. and CHEMOSAT in Europe. Both are the same drug/device combination that delivers high-dose melphalan chemotherapy directly to the liver while filtering out most of the drug before it re-enters systemic circulation, limiting toxic side effects. The procedure — percutaneous hepatic perfusion — takes roughly two to three hours and is performed by an interventional radiologist. HEPZATO is FDA-approved for metastatic uveal melanoma with unresectable liver metastases, a rare cancer affecting an estimated 800 eligible U.S. patients annually. Delcath sells HEPZATO to major academic cancer centers, which must complete a training and certification process before treating patients; as of early 2026, there are 28 certified active sites. The kit is priced at approximately $189,000 per treatment, with patients averaging roughly four treatment cycles, meaning each new patient generates multiple kit purchases. Revenue is directly tied to procedure volume, and gross margins are high given the fixed bill of materials and premium list price. About half of kits are sold at a discount under the 340B drug pricing program, bringing the effective average selling price to approximately $175,000. CHEMOSAT in Europe contributes modest revenue and is managed near breakeven. Delcath is running Phase 2 trials to expand HEPZATO into metastatic colorectal cancer and metastatic breast cancer, indications with addressable patient populations roughly seven times larger than the current mUM indication.