NEW YORK, Feb. 22, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that the Company has launched a Healthcare Setting Locator (Locator) on the hepzatokit.com website.

2024年2月22日，纽约/PRNewswire/-Delcath Systems，Inc.（纳斯达克：DCTH），一家专注于治疗原发性和转移性肝癌的介入性肿瘤公司，今天宣布该公司已在hepzatokit.com网站上推出医疗保健设置定位器（Locator）。

Potential patients, caregivers, and healthcare providers may use the Locator to identify healthcare settings, offering treatment with the HEPZATO KIT..

潜在的患者、护理人员和医疗保健提供者可以使用定位器识别医疗保健环境，提供HEPZATO试剂盒治疗。。

Sites included on the Locator are accepting inquiries from patients or their physicians seeking potential treatment with HEPZATO KIT. These sites either have or expect to have completed all training and internal approvals necessary to treat a patient subsequent to the normal screening for eligibility..

定位器上的网站正在接受患者或其医生的询问，以寻求HEPZATO试剂盒的潜在治疗。这些网站已经或预计已经完成了正常筛查合格后治疗患者所需的所有培训和内部批准。。

'The Healthcare Setting Locator, which the Company will update periodically, is an important tool to assist patients, their caregivers, and their healthcare providers, as they consider appropriate treatment options,' said Kevin Muir, Delcath's General Manager of U.S. Interventional Oncology. 'The previously announced establishment of the permanent J-Code for HEPZATO (J9248) and the launch of the Locator are two important steps in providing information and access to patients for this treatment.'.

Delcath美国介入肿瘤学总经理凯文·缪尔（KevinMuir）说，该公司将定期更新的医疗设置定位器是帮助患者、护理人员和医疗保健提供者考虑适当治疗方案的重要工具先前宣布的建立HEPZATO永久J代码（J9248）和启动定位器是为这种治疗提供信息和访问患者的两个重要步骤。”。

'The Healthcare Settings Locator is a great resource for metastatic uveal melanoma patients. Finding treatments is one of the hardest tasks for a mUM patient. With this Locator, patients can find and coordinate care on their own rather than relying only on the treatments their local physician provides,' said Melody Burchett, President of A Cure In Sight, a leading advocacy group for patients with Uveal Melanoma..

“医疗保健设置定位器是转移性葡萄膜黑色素瘤患者的重要资源。寻找治疗方法是母亲患者最困难的任务之一。“有了这个定位器，患者可以自己找到并协调护理，而不仅仅是依靠当地医生提供的治疗，”葡萄膜黑色素瘤领先倡导组织“治愈视力”的总裁Melody Burchett说。。

The HEPZATO KIT is 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..

HEPZATO试剂盒是一种针对成人转移性葡萄膜黑色素瘤（mUM）患者的肝脏定向治疗方法，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。。

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试剂盒（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。

Please see the full Prescribing Information, including BOXED WARNING for the HEPZATO KIT. .

请参阅完整的处方信息，包括HEPZATO试剂盒的盒装警告。

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。。

Forward Looking Statements

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。

Contact:

联系人：

Investor Relations Contact:Ben ShamsianLytham Partners646-829-9701[email protected]

投资者关系联系人：Ben ShamsianLytham Partners646-829-9701[受电子邮件保护]

SOURCE Delcath Systems, Inc.

SOURCE Delcath Systems公司。