{"entity":{"id":"delcath","kind":"company","name":"Delcath Systems","aka":["Delcath","Delcath Systems, Inc.","melphalan for Injection/Hepatic Delivery System"],"tldr":"Delcath makes the Hepzato Kit, the melphalan percutaneous hepatic perfusion system approved by the FDA in 2023 for uveal melanoma that has spread to the liver, and sells the same device in Europe as Chemosat.","summary":"Delcath Systems, based in New York, developed percutaneous hepatic perfusion, a procedure that isolates the liver's blood supply to deliver high-dose melphalan directly to liver tumours while filtering the drug from blood returning to the body. Its Hepzato Kit was approved by the FDA in August 2023 for adults with uveal melanoma and unresectable liver metastases, the first approved liver-directed therapy for that disease, and the device is marketed in Europe as Chemosat. Company facts are from the official website and FDA approval records.","asOf":"2026-09-11","wikipedia":"https://en.wikipedia.org/wiki/Delcath_Systems","links":[{"label":"Official website","url":"https://www.delcath.com/"},{"label":"FDA approval of melphalan as a liver-directed treatment for uveal melanoma","url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-melphalan-liver-directed-treatment-uveal-melanoma"}],"tags":["fda-oce-applicant"],"related":[],"cancers":["uveal-melanoma"],"sections":["surgery","chemotherapy"],"technologies":[],"targets":[],"drugs":["hepzato"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct05022901","nct06607458"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor websites)","editedOn":"2026-09-11"},"hq":"New York, NY","country":"US","companyType":"devices","website":"https://www.delcath.com/","stage":"public","investors":[],"funding":[]},"route":"/companies/delcath/","neighbours":{"cancer":[{"id":"uveal-melanoma","kind":"cancer","name":"Uveal melanoma","route":"/cancers/uveal-melanoma/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"},{"id":"surgery","kind":"section","name":"Surgery & Interventional","route":"/fronts/surgery/"}],"drug":[{"id":"hepzato","kind":"drug","name":"Melphalan hepatic delivery system","route":"/drugs/hepzato/"}],"trial":[{"id":"nct05022901","kind":"trial","name":"An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma","route":"/trials/nct05022901/"},{"id":"nct06607458","kind":"trial","name":"Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatme","route":"/trials/nct06607458/"},{"id":"nct02678572","kind":"trial","name":"FOCUS","route":"/trials/nct02678572/"}]}}