NEW YORK, Jan. 16, 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 the first commercial use of HEPZATO KIT for the treatment of metastatic uveal melanoma (mUM).

纽约，2024年1月16日/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肿瘤公司，今天宣布首次商业使用HEPZATO试剂盒治疗转移性葡萄膜黑色素瘤（mUM）。

The procedure took place at Moffitt Cancer Center in Tampa, Florida by Dr. Jonathan S. Zager, M.D., Chief Academic Officer; Senior Member, Department of Cutaneous, Oncology; Director of Regional Therapies, Moffitt Cancer Center.  Dr. Zager was the global Lead Investigator for the FOCUS Phase 3 trial..

该程序由首席学术官乔纳森·萨格博士在佛罗里达州坦帕的莫菲特癌症中心进行；皮肤肿瘤学系高级成员；莫菲特癌症中心区域治疗主任。博士。扎格是FOCUS 3期试验的全球首席研究员。。

'The fact that patients with difficult to treat metastatic uveal melanoma with limited treatment options now have another alternative is truly remarkable and exciting. There has been a large unmet need for liver directed therapy options to treat this patient population and we intend to incorporate this as standard of care for appropriate patients,' said Dr.

“难以治疗且治疗选择有限的转移性葡萄膜黑色素瘤患者现在有了另一种替代方案，这一事实确实令人惊讶和兴奋。“对肝脏导向治疗选择治疗这一患者群体的需求尚未得到满足，我们打算将其作为适当患者的标准护理，”Dr。

Zager. Dr. Zager enrolled and treated the first and last patients on the FOCUS Phase 3 trial and the team at Moffitt has performed the procedure over 200 times to date..

扎格。扎格博士在FOCUS 3期试验中招募并治疗了第一批和最后一批患者，莫菲特的团队迄今已进行了200多次手术。。

The company is working with numerous other leading cancer centers across the U.S. which have indicated interest in HEPZATO KIT to ensure patients nationwide have access to this important treatment. In conjunction with the first commercial treatment, Delcath also launched websites relating to the HEPZATO KIT, including HEPZATO KIT, HEPZATO KIT REMS, and HEPZATO KIT Access, to support the commercial launch..

该公司正在与美国许多其他领先的癌症中心合作，这些中心表示对HEPZATO试剂盒感兴趣，以确保全国范围内的患者能够获得这种重要的治疗。在第一次商业治疗的同时，Delcath还推出了与HEPZATO KIT相关的网站，包括HEPZATO KIT、HEPZATO KIT REMS和HEPZATO KIT Access，以支持商业推出。。

'The first commercial procedure utilizing HEPZATO KIT in the U.S. is a significant milestone for Delcath and patients suffering from metastatic uveal melanoma. We are proud to continue our relationship with Dr. Zager and the team at Moffitt Cancer Center to bring this unique treatment to appropriate patients in need.

“美国第一个使用HEPZATO试剂盒的商业程序对于Delcath和患有转移性葡萄膜黑色素瘤的患者来说是一个重要的里程碑。我们很自豪能继续与扎格博士和莫菲特癌症中心的团队合作，为有需要的适当患者提供这种独特的治疗方法。

I want to thank all the collaborators and patients who participated in the long but necessary process to bring HEPZATO KIT to market,' said Gerard Michel, Delcath's Chief Executive Officer..

Delcath首席执行官杰拉德·米歇尔（GerardMichel）说，我要感谢所有参与了将HEPZATO试剂盒推向市场的漫长而必要的过程的合作者和患者。。

About HEPZATO KIT

关于HEPZATO KIT

HEPZATO KIT (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, is a combination drug/device product which administers HEPZATO (melphalan) directly to the liver through the HDS, which permits higher drug exposure in target tissues while limiting systemic toxicity..

HEPZATO试剂盒（注射用美法仑/肝脏输送系统）经FDA批准在美国使用，是一种组合药物/设备产品，可通过HDS将HEPZATO（美法仑）直接给予肝脏，从而允许在靶组织中更高的药物暴露，同时限制全身毒性。。

HEPZATO KIT is approved in the United States as a liver-directed treatment for adult patients with uveal melanoma 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试剂盒在美国被批准用于成人葡萄膜黑色素瘤患者的肝脏定向治疗，这些患者的肝转移不可切除，影响肝脏的不到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。。

HEPZATO KIT Important Safety InformationPatients eligible for HEPZATO KIT should NOT have any of the following medical conditions:

HEPZATO试剂盒重要安全信息符合HEPZATO试剂盒条件的患者不应患有以下任何疾病：

Active intracranial metastases or brain lesions with a propensity to bleed

活动性颅内转移或易出血的脑部病变

Liver failure, portal hypertension, or known varices at risk for bleeding

肝衰竭，门静脉高压症或已知有出血风险的静脉曲张

Surgery or medical treatment of the liver in the previous 4 weeks

前4周肝脏的手术或药物治疗

Active cardiac conditions including unstable or severe angina or myocardial infarction), worsening or new-onset congestive heart failure, significant arrhythmias, or severe valvular disease

活动性心脏病，包括不稳定或严重心绞痛或心肌梗塞），恶化或新发充血性心力衰竭，严重心律失常或严重瓣膜病

History of allergies or known hypersensitivity to melphalan or a component or material utilized within the HEPZATO KIT including natural rubber latex, heparin, and severe hypersensitivity to iodinated contrast not controlled by antihistamines and steroids

对美法仑或HEPZATO试剂盒中使用的成分或材料（包括天然胶乳，肝素）过敏或已知超敏的病史，以及对不受抗组胺药和类固醇控制的碘化造影剂的严重超敏

Most common adverse reactions or laboratory abnormalities occurring with HEPZATO KIT treatment are thrombocytopenia, fatigue, anemia, nausea, musculoskeletal pain, leukopenia, abdominal pain, neutropenia, vomiting, increased alanine aminotransferase, prolonged activated partial thromboplastin time, increased alkaline phosphatase, increased aspartate aminotransferase and dyspnea..

HEPZATO试剂盒治疗最常见的不良反应或实验室异常是血小板减少症，疲劳，贫血，恶心，肌肉骨骼疼痛，白细胞减少症，腹痛，中性粒细胞减少症，呕吐，丙氨酸转氨酶升高，活化部分凝血活酶时间延长，碱性磷酸酶升高，天冬氨酸转氨酶升高和呼吸困难。。

Severe peri-procedural complications including hemorrhage, hepatocellular injury, and thromboembolic events may occur via hepatic intra-arterial administration of HEPZATO. HEPZATO KIT is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the HEPZATO KIT REMS.

通过肝动脉内注射HEPZATO可能会发生严重的围手术期并发症，包括出血，肝细胞损伤和血栓栓塞事件。HEPZATO KIT只能通过风险评估和缓解策略（称为HEPZATO KIT REMS）下的受限计划获得。

Myelosuppression with resulting severe infection, bleeding, or symptomatic anemia may occur with HEPZATO. Additional cycles of HEPZATO KIT therapy will be delayed until blood counts have improved..

HEPZATO可能发生骨髓抑制，导致严重感染，出血或症状性贫血。HEPZATO试剂盒治疗的其他周期将延迟，直到血细胞计数有所改善。。

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。

About Delcath Systems, Inc.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 (melphalan for Injection/Hepatic Delivery System), approved for use in the United States by FDA, and CHEMOSAT Hepatic Delivery System for Melphalan percutaneous hepatic perfusion, designated under the medical device regulation for use in Europe and the United Kingdom, are designed to administer high-dose chemotherapy to the liver while controlling systemic exposure and associated side effects during a PHP procedure..

关于Delcath Systems，Inc.Delcath Systems，Inc.是一家介入肿瘤学公司，专注于治疗原发性和转移性肝癌。该公司的专有产品HEPZATO试剂盒（注射用美法仑/肝脏输送系统）经FDA批准在美国使用，以及根据医疗器械法规指定在欧洲和英国使用的用于美法仑经皮肝脏灌注的CHEMOSAT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。。

Forward Looking StatementsThe 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.

前瞻性声明1995年《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.  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.

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。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，包括表格上的文件。

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。