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Delcath Announces Completion of Regulatory Notification Process in New Zealand
Date:10/19/2011

NEW YORK, Oct. 19, 2011 /PRNewswire/ -- Delcath Systems (NASDAQ: DCTH) announced today that the Company has, through its designated sponsor, completed the product notification process for the Delcath Hepatic CHEMOSAT® Delivery system with the Medicines and Medical Device Safety Authority (MEDSAFE) in New Zealand. Completion of this process permits Delcath to legally supply and distribute CHEMOSAT to the New Zealand market. The Company expects to begin supplying the system through an authorized distributor in 2012.

Commenting on the announcement, Eamonn P. Hobbs, President and CEO of Delcath, said, "Completion of the notification process in New Zealand is part of our plans to expand our addressable markets by leveraging our CE Mark for CHEMOSAT. New Zealand is just one of several markets that require CE Mark as a prerequisite that we expect to open over the next few years. We have also completed our filing with the Australian Therapeutic Goods Administration, and expect approval by year-end. We also intend to seek regulatory acceptance in other markets in Asia, Latin America and the Middle East. With market access in New Zealand and anticipated acceptance in Australia by the end of the year, our plans for introducing chemosaturation therapy into the Pacific region have begun."

About Delcath SystemsDelcath Systems, Inc. is a development stage specialty pharmaceutical and medical device company focused on oncology. Delcath's proprietary system for chemosaturation is designed to administer high dose chemotherapy and other therapeutic agents to diseased organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase 3 metastatic melanoma study, and the Company recently completed a multi-arm Phase 2 trial to treat other
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