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February 4, 2013
07:13 EDTDCTHDelcath Systems announces reimbursement for Chemostat in Chermany
Delcath Systems announced that the Institut für das Entgeltsystem im Krankenhaus, the German federal reimbursement agency, has established a reimbursement pathway for the treatment of patients with liver metastases with the Delcath Hepatic CHEMOSAT Delivery System for melphalan hydrochloride. The Value 4 status given to the CHEMOSAT procedure, while not mandating reimbursement, allows participating cancer centers to negotiate reimbursement coverage for the CHEMOSAT procedure with all insurers serving their region. Under the NUB scheme, reimbursement pathways will potentially be available for treatment with CHEMOSAT regardless of primary cancer origin.
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November 10, 2014
06:40 EDTDCTHDelcath Systems treats first patient in Melphalan/HDS Phase 2 trial
Delcath Systems announced that the first treatment has been performed in the company's Global Phase 2 Clinical Program for first-line treatment of patients with unresectable hepatocellular carcinoma, or HCC, or primary liver cancer. A team led by Prof. Dr. med. Thomas J. Vogl, Director of the Institute for Diagnostic and Interventional Radiology at Goethe University Hospital Frankfurt, Germany, treated its first case on November 5. The treating physicians reported that the patient was treated successfully. In Europe, the Company's Phase 2 trial program will investigate the safety and efficacy of Melphalan/HDS treatment without sorafenib in patients with unresectable liver cancer confined to the liver, evaluate tumor response as measured by modified Response Evaluation Criteria in Solid Tumor, or mRECIST, and assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as assess patient-reported clinical outcomes, or quality-of-life. The Company's Phase 2 trial program is expected to include four to seven centers in Europe and the United States, and will seek to enroll approximately 30 patients.

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