Delcath Systems, Inc. is a specialty pharmaceutical and medical device company focused on developing and commercializing therapies for oncology indications, particularly those involving the liver. The company’s flagship product is the Delcath Hepatic Delivery System, a minimally invasive catheter-based device designed to isolate and treat the liver with high-dose chemotherapy. Through percutaneous hepatic perfusion (PHP), the system delivers concentrated doses of melphalan while filtering out the agent before it returns to the systemic circulation, thereby reducing systemic toxicity and enhancing therapeutic efficacy against primary and metastatic liver tumors.
Initially founded in Delaware in 1988 and now headquartered in New York, Delcath Systems built its pipeline around the unique regional perfusion platform. The company conducted extensive clinical trials in the United States and Europe, earning CE mark approval in the European Union for the treatment of unresectable hepatic metastases, particularly for ocular melanoma and colorectal carcinoma. In the United States, the company has pursued regulatory approvals through pivotal trials and supplemental submissions, collaborating with leading cancer centers to refine procedural protocols and expand patient access.
Delcath’s product development strategy extends beyond monotherapy; the company is investigating combination regimens that integrate its hepatic perfusion platform with targeted therapies and immuno-oncology agents, aiming to broaden the clinical utility of regional chemotherapy. The company’s manufacturing operations, quality control, and commercial planning are supported by a dedicated team of scientific advisors, interventional radiologists, and oncology specialists who guide protocol design and post-market surveillance in multiple geographies.
Led by President and CEO Ketan R. Patel, Delcath Systems draws on decades of experience in life sciences, medical devices, and oncology drug development. The executive leadership team includes seasoned professionals in regulatory affairs, clinical operations, and commercial strategy, ensuring coordinated efforts to advance the company’s mission. Through partnerships, investigator-sponsored studies, and a growing body of real-world evidence, Delcath continues to explore new indications and therapeutic combinations for patients with liver-dominant cancers worldwide.
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