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Delcath Systems Announces CMS Approval for NTAP for HEPZATO KIT™
QUEENSBURY, N.Y.--(BUSINESS WIRE)-- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and
About this update from Delcath Systems, Inc.
[{"type":"text","content":" QUEENSBURY, N.Y.--(BUSINESS WIRE)--\nDelcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, announced today that the Centers for Medicare & Medicaid Services (CMS) has granted New Technology Add-on Payment (NTAP) status for its HEPZATO KIT™ (melphalan/Hepatic Delivery System). This approval will be effective for the fiscal year starting October 1, 2024.\n\n\nThe NTAP designation under the CMS Inpatient Prospective Payment System (IPPS) is designed to support the adoption of innovative medical technologies that provide substantial clinical improvement over existing treatments. HEPZATO KIT™ is used primarily in the outpatient setting, however there are instances where it is used in the inpatient setting. This additional payment will help to cover the costs associated with the HEPZATO KIT for eligible Medicare inpatients, ensuring that more patients can benefit from this advanced liver-directed therapy.\n\n\n\"The NTAP approval for HEPZATO KIT is a significant milestone that underscores the clinical value of our therapy. This will facilitate broader access to HEPZATO KIT for eligible patients and support the oncology community in delivering this important treatment,\" stated Gerard Michel, CEO of Delcath Systems.\n\n\nThe HEPZATO KIT is a combination product that delivers melphalan, a chemotherapeutic agent, directly to the liver using Delcath’s proprietary Hepatic Delivery System (HDS). This system isolates the liver during the infusion process, allowing for high-dose chemotherapy administration while minimizing systemic exposure. The HEPZATO KIT is indicated for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma.\n\n\nAbout Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT\n\n\nDelcath Systems, Inc. is an interventional oncology company focused on the treatment of primary and metastatic liver cancers. The company's proprietary products, HEPZATO KIT™ (Hepzato (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT® Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure.\n\n\nIn the United States, HEPZATO KIT is considered a combinat...