QUEENSBURY, N.Y.--(

纽约昆斯伯里--(

BUSINESS WIRE

商业热线

)--Delcath Systems, Inc. (Nasdaq: DCTH) (“Delcath” or the “Company”), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced an update to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines.

)--Delcath Systems，Inc.（纳斯达克代码：DCTH）（“Delcath”或“公司”）是一家专注于治疗原发性和转移性肝癌的介入性肿瘤公司，今天宣布更新国家综合癌症网络（NCCN）肿瘤学临床实践指南（NCCN指南）。

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) for the treatment of metastatic uveal melanoma (mUM). Our proprietary products, HEPZATO KIT™ (HEPZATO (melphalan) for Injection/Hepatic Delivery System) and CHEMOSAT

)用于治疗转移性葡萄膜黑色素瘤（mUM）。我们的专有产品HEPZATO KIT™（注射用HEPZATO（美法仑）/肝输送系统）和CHEMOSAT

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Hepatic Delivery System for Melphalan percutaneous hepatic perfusion (PHP), are designed to administer high-dose chemotherapy to the liver.

美法仑经皮肝灌注（PHP）的肝脏输送系统旨在对肝脏进行高剂量化疗。

The updated NCCN Guidelines now include HEPZATO KIT as a Category 2A treatment option for patients with hepatic-dominant uveal melanoma. Previously, the guidelines limited its use to patients with metastases confined to the liver. This revision aligns with the HEPZATO KIT label. Given that over 90% of mUM patients develop liver metastases, and the liver is typically the life-limiting organ, this update expands the recommended patient population for which HEPZATO KIT may be considered an appropriate treatment option.

最新的NCCN指南现在包括HEPZATO试剂盒作为肝显性葡萄膜黑色素瘤患者的2A类治疗选择。此前，该指南仅限于局限于肝脏转移的患者。此修订版与HEPZATO试剂盒标签一致。鉴于超过90%的mUM患者发生肝转移，并且肝脏通常是限制生命的器官，本次更新扩大了推荐的患者人群，HEPZATO试剂盒可能被认为是一种合适的治疗选择。

A previously published subgroup analysis from the Phase 3 FOCUS trial demonstrated no significant differences in objective response rate, progression-free survival, or overall survival between patients with and without extrahepatic disease..

先前发表的3期FOCUS试验的亚组分析显示，有无肝外疾病患者的客观缓解率，无进展生存期或总生存期无显着差异。。

“We are encouraged by the NCCN’s decision to expand HEPZATO’s recommendation in the guidelines to include patients with extrahepatic disease, recognizing the critical role hepatic progression plays in the course of metastatic uveal melanoma,” said Gerard Michel, Chief Executive Officer of Delcath. “This update underscores the growing recognition of HEPZATO as an important treatment option for patients battling this challenging disease.”.

Delcath首席执行官杰拉德·米歇尔（Gerard Michel）表示：“我们对NCCN决定将HEPZATO在指南中的建议扩大到包括肝外疾病患者感到鼓舞，认识到肝脏进展在转移性葡萄膜黑色素瘤过程中起着关键作用。”。“这一更新强调了人们越来越认识到HEPZATO是与这种具有挑战性的疾病作斗争的患者的重要治疗选择。”。

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

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CHEMOSAT

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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.

美法仑经皮肝灌注（PHP）的肝脏输送系统旨在对肝脏进行高剂量化疗，同时控制PHP手术期间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 isolate the hepatic venous blood from the systemic circulation 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用于从体循环中分离肝静脉血，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。

Please see the full .

请查看全文。

Prescribing Information

处方信息

, including BOXED WARNING for the HEPZATO KIT.

，包括HEPZATO套件的盒装警告。

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。。

Safe Harbor / Forward-Looking Statements

安全港/前瞻性声明

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This press release contains forward-looking statements, which are subject to certain risks and uncertainties, that can cause actual results to differ materially from those described.

1995年的《私人证券诉讼改革法案》为公司或其代表所作的前瞻性声明提供了安全港。本新闻稿包含前瞻性声明，这些声明受到某些风险和不确定性的影响，可能导致实际结果与所描述的结果存在重大差异。

The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“预期”，“相信”，“继续”，“可能”，“估计”，“期望”，“打算”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“意志”，“将会”和类似的表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Factors that may cause such differences include, but are not limited to, uncertainties relating to: the Company's commercialization plans and its ability to successfully commercialize the HEPZATO KIT; the Company's successful management of the HEPZATO KIT supply chain, including securing adequate supply of critical components necessary to manufacture and assemble the HEPZATO KIT; successful FDA inspections of the facilities of the Company and those of its third-party suppliers/manufacturers; the Company's successful implementation and management of the HEPZATO KIT Risk Evaluation and Mitigation Strategy; the potential benefits of the HEPZATO KIT as a treatment for patients with primary and metastatic disease in the liver; the Company's ability to obtain reimbursement for the HEPZATO KIT; and the Company's ability to successfully enter into any necessary purchase and sale agreements with users of the HEPZATO KIT.

可能导致这种差异的因素包括但不限于以下不确定性：公司的商业化计划及其成功商业化HEPZATO试剂盒的能力；该公司成功管理了HEPZATO试剂盒供应链，包括确保生产和组装HEPZATO试剂盒所需的关键部件的充足供应；FDA成功检查了公司及其第三方供应商/制造商的设施；公司成功实施和管理HEPZATO KIT风险评估和缓解策略；HEPZATO试剂盒作为肝脏原发性和转移性疾病患者治疗的潜在益处；公司获得HEPZATO试剂盒报销的能力；以及该公司与HEPZATO套件用户成功签订任何必要的购销协议的能力。

For additional information about these factors, and others that may impact the Company, please see the Company's filings with the Securities and Exchange Commission, including those on Forms 10-K, 10-Q, and 8-K. Howeve.

有关这些因素以及其他可能影响公司的因素的更多信息，请参阅公司向证券交易委员会提交的文件，包括10-K、10-Q和8-K表格中的文件。Howeve。