Business
Delcath Systems Announces Third Quarter 2021 Results
NEW YORK, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary
About this update from Delcath Systems, Inc.
[{"type":"text","content":"NEW YORK, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, today reported business highlights and financial results for the third quarter ended September 30, 2021. Recent Business Highlights During and since the third quarter Delcath: Entered a debt facility with Avenue Venture Opportunities Fund, L.P. providing up to $20 million with an initial $15 million funded at closing,Submitted to and received approval from the FDA for an expanded access protocol for the use of HEPZATO™ Kit (melphalan hydrochloride for injection/hepatic delivery system) in the treatment of patients with liver dominant metastatic ocular melanoma,Updated guidance of the Class 2 resubmission of the NDA to mid-year from the end of the first quarter,Hired 3 senior executives in clinical operations, regulatory and medical affairs to support the resubmission of the NDA and further clinical development of HEPZATO, andAnnounced it will host a comprehensive Investor Update event on Thursday, December 2nd, from 10:00am ET – 1:00pm ET covering FOCUS trial results as well as development plans for the use of HEPZATO in the treatment of patients with intrahepatic cholangiocarcinoma and colorectal cancer. In addition, during the third quarter independent investigators: Presented three abstracts on the use of Chemosat® Hepatic Delivery System with Melphalan in the treatment of metastatic ocular melanoma (mOM) at the 2021 Cardiovascular and Interventional Radiological Society of Europe conference (CIRSE) including, Safety and toxicity of combining hepatic percutaneous perfusion with ipilimumab plus nivolumab in advanced uveal melanoma: phase 1b of the CHOPIN Trial1Long-term results of percutaneous hepatic perfusion with melphalan in patients with unresectable liver metastases from uveal melanoma: a multicenter retrospective study2Safety and efficacy of chemosaturation with percutaneous hepatic perfusion of melphalan for metastatic uveal melanoma: an 8-year retrospective study of 250 interventions in 81 patients3 Published Repeated percutaneous hepatic perfusion with melphalan can maintain long-term response in patients with liver cancers4 in the journal Cardiovascular and Interventional Radiology. “It’s very exciting to see the initial res...