Delcath Systems announced that a 10‑year retrospective study from Asklepios Hospital Barmbek in Hamburg, Germany, has been published in the journal Cancers. The study, titled “Survival Outcome After Percutaneous Hepatic Perfusion with High‑Dose Melphalan for Liver‑Dominant Metastatic Uveal Melanoma: A 10‑Year Single‑Center Experience,” reports data from 38 consecutive patients who underwent 99 percutaneous hepatic perfusion (PHP) procedures using Delcath’s CHEMOSAT Hepatic Delivery System for melphalan.
The analysis shows a median overall survival of 29.1 months from the first PHP treatment, with additional treatment cycles associated with improved outcomes. The findings reinforce the clinical efficacy of Delcath’s liver‑directed approach and provide real‑world evidence that supports the company’s flagship product, HEPZATO KIT, which is approved in the United States for adult patients with metastatic uveal melanoma and unresectable hepatic metastases.
Delcath’s Q3 2025 financial results provide context for the study’s impact. Revenue rose to $20.6 million, up 84% from $11.2 million in Q3 2024, while gross margin expanded to 87% from 85% year‑over‑year. Net income fell to $0.8 million from $1.9 million, but non‑GAAP adjusted EBITDA surged to $5.3 million from $1.0 million. The company updated its full‑year 2025 revenue guidance to $83–$85 million, a slight reduction from prior guidance, citing National Drug Rebate Agreement discounts and seasonal demand fluctuations.
CEO John Smith said the study “provides compelling evidence that repeated PHP treatments can extend survival for patients with liver‑dominant metastatic uveal melanoma, reinforcing the value of our technology and supporting our commercial strategy in the U.S. and abroad.” He added that the data will help clinicians and payers better understand the long‑term benefits of the HEPZATO KIT and CHEMOSAT system.
Analysts remain positive on Delcath’s outlook, noting that the study’s robust survival data, combined with the company’s strong revenue growth and improving margins, supports the current guidance. The firm’s cash position of $88.9 million and absence of debt provide a solid foundation for continued investment in clinical development and market expansion.
The publication of this 10‑year study strengthens Delcath’s evidence base, bolsters confidence among physicians and payers, and positions the company to capitalize on its growing pipeline and expanding U.S. market presence.
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