Business
Delcath Systems Reports Fourth Quarter and Full-Year 2021 Results and Provides Business Update
NEW YORK, March 25, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and
About this update from Delcath Systems, Inc.
[{"type":"text","content":"NEW YORK, March 25, 2022 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today reported business highlights and financial results for the fourth quarter and full-year ended December 31, 2021. Recent Business Highlights During and since the fourth quarter, Delcath: Reported updated positive phase 3 FOCUS trial results for HEPZATO™ Kit (melphalan hydrochloride for injection/hepatic delivery system) for the treatment of patients with unresectable liver-dominant metastatic ocular melanoma, including initial survival data analysisConfirmed guidance for the mid-year Class 2 resubmission of the NDA to FDAResumed direct responsibility for sales, marketing, and distribution activities for the CHEMOSAT® Hepatic Delivery System in all of Europe Achieved medical device regulation certification for CHEMOSAT® in EuropeAppointed David Hoffman as General Counsel and Chief Compliance Officer and Anthony Dias as Vice President of Finance In addition, during and since the fourth quarter, independent investigators published: Repeated percutaneous hepatic perfusion with melphalan can maintain long-term response in patients with liver cancers in the journal Cardiovascular and Interventional Radiology1Chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma in the journal Melanoma Research2Percutaneous Hepatic Perfusion (PHP) with Melphalan in Liver-Dominant Metastatic Uveal Melanoma: The German Experience in the journal Cancers3Initiation of Chemosaturation with Percutaneous Hepatic Perfusion Program in Interventional Radiology Department in the journal Cureus4 “Since the end of the third quarter, we have updated our previously reported positive phase 3 data with survival data, resumed direct sales of CHEMOSAT in Europe, and strengthened our leadership team,” said Gerard Michel, CEO of Delcath. “Each of these achievements support our strategic priorities – filing of the HEPZATO NDA in mid-2022, preparing for the subsequent US launch when approved, and expanding the development of HEPZATO and CHEMOSAT into additional areas of high unmet need. We look forward to a pre-NDA meeting with FDA in the coming weeks.” Fourth Quarter 2021 Results Income Statement Highlights. Product revenue for the three mon...