QUEENSBURY, N.Y.--(BUSINESS WIRE)--Delcath 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).

纽约昆斯伯里（商业新闻短讯）--专注于原发性和转移性肝癌治疗的介入性肿瘤公司Delcath Systems，Inc.（纳斯达克：DCTH）今天宣布，医疗保险和医疗补助服务中心（CMS）已为其HEPZATO KIT™（美法仑/肝输送系统）授予新技术附加支付（NTAP）身份。

This approval will be effective for the fiscal year starting October 1, 2024..

该批准将于2024年10月1日开始的财政年度生效。。

The 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.

CMS住院患者预期支付系统（IPPS）下的NTAP指定旨在支持采用创新的医疗技术，从而为现有治疗提供实质性的临床改进。HEPZATO KIT™主要用于门诊，但也有在住院患者中使用的情况。

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..

这笔额外付款将有助于支付符合条件的医疗保险住院患者的HEPZATO试剂盒相关费用，确保更多患者可以从这种先进的肝脏导向治疗中受益。。

'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..

NTAP批准HEPZATO试剂盒是一个重要的里程碑，突显了我们治疗的临床价值。Delcath Systems首席执行官杰拉德·米歇尔（GerardMichel）表示，这将有助于合格患者更广泛地使用HEPZATO试剂盒，并支持肿瘤学界提供这一重要治疗。。

The 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.

HEPZATO试剂盒是一种组合产品，使用Delcath专有的肝脏输送系统（HDS）将化学治疗剂美法仑直接输送到肝脏。该系统在输注过程中隔离肝脏，允许高剂量化疗给药，同时最大程度地减少全身暴露。

The HEPZATO KIT is indicated for the treatment of adult patients with unresectable hepatic-dominant metastatic uveal melanoma..

HEPZATO试剂盒适用于治疗无法切除的肝显性转移性葡萄膜黑色素瘤的成年患者。。

About Delcath Systems, Inc., HEPZATO KIT and CHEMOSAT

关于Delcath Systems，Inc.，HEPZATO KIT和CHEMOSAT

Delcath 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..

Delcath Systems，Inc.是一家介入肿瘤公司，专注于原发性和转移性肝癌的治疗。该公司的专有产品HEPZATO KIT™（注射用HEPZATO（美法仑）/肝输送系统）和用于美法仑经皮肝灌注（PHP）的CHEMOSAT®肝输送系统旨在对肝脏进行高剂量化疗，同时控制PHP过程中的全身暴露和相关副作用。。

In the United States, HEPZATO KIT is considered a combination drug and device product and is regulated and approved for sale as a drug by the FDA. HEPZATO KIT is comprised of the chemotherapeutic drug melphalan and Delcath's proprietary Hepatic Delivery System (HDS). The HDS is used to surgically isolate the liver while simultaneously filtrating hepatic venous blood during melphalan infusion and washout.

在美国，HEPZATO试剂盒被认为是药物和器械的组合产品，并被FDA监管并批准作为药物销售。HEPZATO试剂盒由化疗药物美法仑和Delcath专有的肝脏输送系统（HDS）组成。HDS用于手术隔离肝脏，同时在美法仑输注和冲洗过程中过滤肝静脉血。

The use of the HDS results in loco-regional delivery of a relatively high melphalan dose, which can potentially induce a clinically meaningful tumor response with minimal hepatotoxicity and reduce systemic exposure. HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

HDS的使用导致相对较高的美法仑剂量的局部区域递送，这可能以最小的肝毒性诱导临床上有意义的肿瘤反应并减少全身暴露。HEPZATO试剂盒在美国被批准用于成人转移性葡萄膜黑色素瘤（mUM）患者的肝脏定向治疗，其不可切除的肝转移影响不到肝脏的50%，并且没有肝外疾病，或者肝外疾病仅限于骨骼，淋巴结，皮下组织或肺部，可以切除或放疗。

In Europe, the device-only configuration of the HDS is regulated as a Class III medical device and is approved for sale under the trade name CHEMOSAT Hepatic Delivery System for Melphalan, or CHEMOSAT, where it has been used in the conduct of percutaneous hepatic perfusion procedures at major medical centers to treat a wide range of cancers of the liver..

在欧洲，HDS的仅设备配置被规定为III类医疗器械，并被批准以商品名CHEMOSAT Hepatic Delivery System for Melphalan或CHEMOSAT销售，该商品名已用于在主要医疗中心进行经皮肝灌注手术，以治疗多种肝癌。。