Delcath Systems, Inc.

Delcath Systems, Inc. develops and commercializes HEPZATO KIT (melphalan hydrochloride), a drug-device combination product designed for a procedure called percutaneous hepatic perfusion (PHP). The PHP procedure is used to treat certain cancers that have metastasized to the liver. The development and regulatory approval of such pharmaceutical products inherently requires animal testing to demonstrate safety and efficacy before human clinical trials can commence. This standard industry practice constitutes commercial exploitation of animals under the firm's exclusion criteria.

The company's public filings and regulatory communications consistently reference the requirement for additional clinical trials to support marketing applications. For example, Delcath's 2024 Form 10-K states that "FDA or other foreign regulatory agencies may require Delcath to perform additional trials before approving our marketing application." The necessity for these human trials is predicated on prior animal testing data, confirming the company's ongoing reliance on animal models within its product development lifecycle.