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Delcath Announces Fiscal 2011 Third Quarter Results and Recent Developments
Date:11/7/2011

NEW YORK, Nov. 7, 2011 /PRNewswire/ -- Delcath Systems (NASDAQ: DCTH) today reported financial results for the fiscal 2011 third quarter ended September 30, 2011.  Highlights for the quarter and recent developments include:

  • Research & Development:  Accelerated development of Generation Two of the Delcath Hepatic CHEMOSAT® Delivery system, which has demonstrated significantly higher filtration efficiency of melphalan in pre-clinical testing compared to Generation One of the system.
  • European Commercialization: Submission of CE Mark application for high-efficiency filter of Generation Two CHEMOSAT system, and earlier than anticipated availability of Generation Two for initial launch in European markets in early Q1 2012, subject to CE Mark approval.
  • Establishment of European Business Entity & Headquarters: Formation of Delcath Systems Ltd. (Delcath Limited), an Irish company headquartered in Galway, Ireland, under which Delcath will conduct its European operations. Delcath Limited received a development grant from IDA Ireland to support the hiring of staff over the next three years.
  • U.S. Regulatory:  Pre-New Drug Application (NDA) meeting scheduled with U.S. Food and Drug Administration (FDA) for mid-January 2012.
  • International Regulatory:  Completion of product notification process for CHEMOSAT with the Medicines and Medical Device Safety Authority in New Zealand, and submission of applications to obtain regulatory approval for CHEMOSAT for several other markets including Australia, Singapore and Hong Kong. The Company also submitted an application to obtain European CE Mark approval for the Generation Two high efficiency filter.
  • Clinical Trial Data Update: Updated efficacy results from the Company's Phase 3 trial showed the potential for CHEMOSAT as a promising
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