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Delcath Announces Agreement With Istituto Nazionale Tumori Fondazione G. Pascale for Further Expansion of CHEMOSAT in Italy
Date:3/27/2012

he United States. The Company continues with the preparation of its NDA submission and intends to seek FDA approval for commercial sale of its chemosaturation system with melphalan. For more information, please visit the Company's website at www.delcath.com.

The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by the Company or on its behalf. This news release contains forward-looking statements, which are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to, uncertainties relating to: the future use and adoption of the CHEMOSAT system by the Istituto Nazionale Tumori Fondazione G. Pascale, patient outcomes from CHEMOSAT procedures, 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
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SOURCE Delcath Systems, Inc.
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1. Delcath Announces Agreement with Instituto Oncologico Baselga for Launch of CHEMOSAT in Spain
2. Delcath Announces Agreement With Institut Gustave Roussy for Launch of Hepatic CHEMOSAT Delivery System in France
3. Delcath Announces First CHEMOSAT Procedures in Germany
4. Delcath Announces Agreement With University Medical Center Schleswig-Holstein for Use of Its Hepatic CHEMOSAT Delivery System
5. Delcath CHEMOSAT Presented as Innovative Treatment for Liver Metastases by European Institute of Oncology
6. Delcath Receives Regulatory Approval to Commercialize Hepatic CHEMOSAT® Delivery System in Australia
7. Delcaths Ireland Operations Achieves ISO 13485 Certification
8. Delcath Announces Agreement With the Frankfurt University Hospital for Launch of Hepatic CHEMOSAT Delivery System in Germany
9. Delcath Appoints Gregory Gores, M.D. to Medical Advisory Board
10. Delcath Announces Agreement With European Institute of Oncology for Initial Launch of Hepatic Chemosat Delivery System in the European Union
11. Delcath to Present at the Lazard Healthcare Conference on November 15
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