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Delcath Announces Agreement With University Medical Center Schleswig-Holstein for Use of Its Hepatic CHEMOSAT Delivery System
Date:2/16/2012

to, uncertainties relating to: the future use and adoption of the CHEMOSAT system by the University Medical Center Schleswig-Holstein, future initial launch and training agreements with other cancer centers in Europe, CE Marking for the Generation Two system and the timing of our commercial launch in Europe, the time required to build inventory and establish commercial operations in Europe, adoption, use and resulting sales, if any, for the Hepatic CHEMOSAT delivery system in the EEA, our ability to successfully commercialize the chemosaturation system and the potential of the chemosaturation system as a treatment for patients with terminal metastatic disease in the liver, acceptability of the Phase III clinical trial data by the FDA, our ability to address the issues raised in the Refusal to File letter received from the FDA and the timing of our re-submission of our NDA, re-submission and acceptance of the Company's NDA by the FDA, approval of the Company's NDA for the treatment of metastatic melanoma to the liver, adoption, use and resulting sales, if any, in the United States, approval of the current or future chemosaturation system for other indications, actions by the FDA or other foreign regulatory agencies, our ability to obtain reimbursement for the CHEMOSAT system, our ability to successfully enter into distribution and strategic partnership agreements in foreign markets and the corresponding revenue associated with such foreign markets, uncertainties relating to the results of research and development projects and future clinical trials, and uncertainties regarding our ability to obtain financial and other resources for any research, development and commercialization activities. These factors, and others, are discussed from time to time in our filings with the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date they are made. We undertake no obligation
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SOURCE Delcath Systems, Inc.
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Related medicine technology :

1. Delcath CHEMOSAT Presented as Innovative Treatment for Liver Metastases by European Institute of Oncology
2. Delcath Receives Regulatory Approval to Commercialize Hepatic CHEMOSAT® Delivery System in Australia
3. Delcaths Ireland Operations Achieves ISO 13485 Certification
4. Delcath Announces Agreement With the Frankfurt University Hospital for Launch of Hepatic CHEMOSAT Delivery System in Germany
5. Delcath Appoints Gregory Gores, M.D. to Medical Advisory Board
6. Delcath Announces Agreement With European Institute of Oncology for Initial Launch of Hepatic Chemosat Delivery System in the European Union
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10. FDA Schedules Delcath Pre-New Drug Application Meeting Date
11. Delcath Announces Completion of Regulatory Notification Process in New Zealand
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