Delcath Systems Announces Healthcare Setting Locator for HEPZATO™ KIT (melphalan/Hepatic Delivery System)

Rhea-AI Summary

Delcath Systems, Inc. (DCTH) launches Healthcare Setting Locator for HEPZATO KIT, a liver-directed treatment for metastatic uveal melanoma patients. The Locator aims to assist patients, caregivers, and healthcare providers in finding treatment sites and accessing necessary information.

Insights

Oncology Doctor

The introduction of the Healthcare Setting Locator for Delcath Systems' HEPZATO KIT represents a significant advancement in patient care for those suffering from metastatic uveal melanoma (mUM). This tool facilitates access to treatment by enabling patients and healthcare providers to identify appropriate healthcare settings for the administration of the HEPZATO KIT. It is crucial to note that mUM is a rare and aggressive cancer and options for targeted therapy are limited. Therefore, the availability of such a locator can be pivotal in expediting treatment, potentially improving patient outcomes.

From a clinical perspective, the HEPZATO KIT, which is designed for liver-directed therapy, offers a specialized treatment for a niche patient demographic. The treatment's specificity for patients with unresectable hepatic metastases and limited extrahepatic disease underscores the importance of precision medicine in oncology. As an oncologist, the ability to direct patients to qualified treatment centers can streamline the treatment process, reduce the burden on patients and caregivers and contribute to a more efficient healthcare delivery system.

Medical Research Analyst

Delcath Systems' strategy to launch a dedicated Locator for their HEPZATO KIT aligns with the broader trend in the pharmaceutical industry towards improving patient access and support services. The Locator not only serves as a patient aid but also acts as a marketing tool to increase the visibility and adoption of the HEPZATO KIT among healthcare providers. By simplifying the process of finding treatment locations, Delcath is likely to see an uptick in the utilization of their product.

Furthermore, the establishment of a permanent J-Code for HEPZATO (J9248) is a critical step in ensuring reimbursement and reducing financial barriers for patients. This coding is essential for billing and insurance purposes and often influences the adoption rate of new medical treatments. The combination of the Locator and the J-Code could result in increased market penetration and a positive impact on Delcath's financial performance, as it may lead to a higher volume of treatments administered.

Market Research Analyst

The deployment of the Healthcare Setting Locator by Delcath Systems is indicative of a company actively working to enhance its product's marketability and patient reach. In the context of the stock market, such initiatives can be viewed favorably by investors as they demonstrate the company's commitment to supporting its products post-launch. It's a strategic move that can strengthen the company's competitive position within the interventional oncology space.

Analyzing the potential impact on Delcath's stock, investors will likely monitor the adoption rates post-launch of the Locator and the subsequent financial results. Increased accessibility and ease of locating treatment centers could translate into higher demand for the HEPZATO KIT. Long-term, the success of such tools can contribute to the company's reputation and brand loyalty among both patients and healthcare providers, which is an intangible asset that can have a positive influence on the company's valuation.

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

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.

"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."

"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.

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.

About Delcath Systems, Inc., HEPZATO KIT and 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.

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

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.

Forward Looking Statements

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. 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. 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 10-K, 10-Q, and 8-K. However, new risk factors and uncertainties may emerge from time to time, and it is not possible to predict all risk factors and uncertainties. Accordingly, you should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation to publicly update or revise these forward-looking statements to reflect events or circumstances after the date they are made.

Contact:

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

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SOURCE Delcath Systems, Inc.

FAQ

What is the purpose of the Healthcare Setting Locator launched by Delcath Systems, Inc. (DCTH)?

The Locator aims to assist potential patients, caregivers, and healthcare providers in identifying healthcare settings offering treatment with the HEPZATO KIT for metastatic uveal melanoma.

Who can use the Healthcare Setting Locator on the hepzatokit.com website?

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

What is the significance of the J-Code for HEPZATO (J9248) in relation to the launch of the Healthcare Setting Locator?

The establishment of the permanent J-Code for HEPZATO and the launch of the Locator are important steps in providing information and access to patients for this treatment.

What is the target patient population for the HEPZATO KIT?

The HEPZATO KIT is a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with specific criteria regarding hepatic metastases and extrahepatic disease.

How does the Healthcare Setting Locator benefit metastatic uveal melanoma patients?

The Locator serves as a valuable resource for patients in finding and coordinating care for metastatic uveal melanoma, providing additional treatment options beyond local physician recommendations.