Delcath Systems, Inc.
DCTH
Health Care
2
exclusion reasons
1 theme
Delcath Systems, Inc. is screened out under 2 exclusion reasons spanning 1 issue category.
This page is part of our public exclusion list — a transparency tool that shows which companies we screen out and why. It is not investment advice, and it is not an accusation. It is a statement of values.
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.
Delcath Systems, Inc. is a pharmaceutical company whose sole commercial product, HEPZATO KIT, is a liver-directed cancer therapy. The company's FDA regulatory filings explicitly state that the product's development required the "completion of extensive preclinical laboratory tests and preclinical animal studies, all performed in accordance with the FDA's good laboratory practice (GLP) regulations." This animal testing was a mandatory component of the regulatory pathway to gain marketing approval for the drug. As a development-stage biopharmaceutical company, Delcath's business model is inherently reliant on animal testing to advance its therapeutic candidates through the clinical trial process.
Research Sources
1 organization
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