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Delcath Receives Regulatory Approval to Commercialize Hepatic CHEMOSAT® Delivery System in Australia
Date:2/14/2012

NEW YORK, Feb. 14, 2012 /PRNewswire/ -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced the Therapeutic Goods Administration (TGA) division of the Australian government has approved the Delcath Hepatic CHEMOSAT® Delivery system for listing on the Australian Register of Therapeutic Goods (ARTG).  The TGA's approval allows Delcath to market and sell the system in Australia.

"Regulatory approval in Australia represents another achievement for Delcath as we seek to expand the global addressable markets for our CHEMOSAT system," said Eamonn P. Hobbs, President and CEO of Delcath.  "We believe chemosaturation therapy via our CHEMOSAT system will provide an important treatment alternative for liver cancer patients in the Australian market."

Delcath received CE Marking for CHEMOSAT in April 2011 in the European Union, allowing Delcath to market and sell the product in countries in the European Economic Area.  In October 2011, Delcath completed the product notification process through its designated sponsor for the CHEMOSAT system with the Medicines and Medical Device Safety Authority in New Zealand.

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 III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The Company has not y
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SOURCE Delcath Systems, Inc.
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