Delcath Systems, Inc. (NASDAQ: DCTH)

Delcath Systems, Inc. is an interventional oncology company focused on the treatment of cancers primary or metastatic to the liver. The company's lead product, the HEPZATO KIT, is a drug/device combination that received FDA approval in August 2023 for adult patients with uveal melanoma liver metastases. In Europe, the company markets the CHEMOSAT hepatic delivery system, a device used to deliver melphalan to the liver during percutaneous hepatic perfusion procedures. These products enable high dose chemotherapy delivery to the liver while limiting systemic exposure.

Delcath Systems, Inc. generates revenue primarily from the sale of its HEPZATO KIT in the United States and the CHEMOSAT system in Europe. The company states it has sufficient raw material and component parts to meet anticipated demand and manages supply chain risk through stockpiled inventory, as well as by contracting with multiple suppliers for critical components. Since March 1, 2022, Delcath has assumed direct responsibility for sales, marketing, and distribution of CHEMOSAT in Europe. The company also provides training, as well as support services, to hospitals and cancer centers that use its products.

The company operates through the following segments:

• Single Operating Segment: The company's single operating segment includes the development, manufacturing, and commercialization of the HEPZATO KIT drug/device combination, as well as the CHEMOSAT hepatic delivery system, for percutaneous hepatic perfusion procedures aimed at treating primary and metastatic liver cancers.

Delcath Systems, Inc. competes in the interventional oncology market against surgical resection, liver transplant, systemic chemotherapy, and other locoregional therapies such as transarterial chemoembolization and radioembolization. In the specific indication of uveal melanoma liver metastases, the company faces competition from the approved drug KIMMTRAK. It also faces competition from emerging therapies from IDEAYA Biosciences, as well as from Replimune Group. Additionally, competitors such as Boston Scientific Corporation, the Covidien products division of Medtronic plc, Merit Medical Systems, Inc., Varian Medical Systems, Inc., Sirtex Medical Limited, and AngioDynamics, Inc. offer devices for transarterial chemoembolization and radioembolization procedures. Delcath's competitive advantages include the ability to treat the entire liver, including radiologically invisible micrometastases, the repeatability of the percutaneous hepatic perfusion procedure, and six orphan drug designations that provide market exclusivity.

Delcath Systems, Inc. serves hospitals and cancer centers in the United States and Europe that perform percutaneous hepatic perfusion procedures. In the United States, the company reported 32 sites accepting referrals with 25 active sites as of December 31, 2025. In Europe, CHEMOSAT is available in 22 cancer centers across the region.