NEW YORK,NY-September 13, 2013 - Delcath Systems, Inc. (NASDAQ: DCTH) today
announced that the U.S. Food and Drug Administration (FDA) has issued a
complete response letter (CRL) received September 12, 2013 regarding the New
Drug Application (NDA) for Delcath's Melblez^TM Kit (Melblez (melphalan) for
Injection for use with the Delcath Hepatic Delivery System) for the treatment
of patients with unresectable ocular melanoma metastatic to the liver.

A CRL is issued by the FDA when the review of a file is completed and
questions remain that precludes approval of the NDA in its current form. The
FDA comments included a statement that Delcath must perform another
"well-controlled randomized trial(s) to establish the safety and efficacy of
Melblez Kit using overall survival as the primary efficacy outcome measure,"
and which "demonstrates that the clinical benefits of Melblez Kit outweigh its
risks." In addition to the FDA requirement to conduct an additional clinical
trial(s) using the product the Company intends to market, Delcath is
evaluating the other requirements contained in the letter, and will review
potential regulatory paths forward with the FDA.

About Delcath Systems

Delcath Systems, Inc. is a specialty pharmaceutical and medical device company
focused on oncology. Our proprietary drug/device combination product, the
Delcath Hepatic Delivery System, is designed to administer high dose
chemotherapy and other therapeutic agents to the liver, while controlling the
systemic exposure of those agents. The Company's initial focus is on the
treatment of primary and metastatic liver cancers. Outside of the United
States, our proprietary product to deliver and filter melphalan hydrochloride
is marketed under the trade name Delcath Hepatic CHEMOSAT® Delivery System for
melphalan hydrochloride. The Company obtained authorization to affix a CE Mark
for the Generation Two CHEMOSAT Delivery System for Melphalan in April 2012.
The right to affix the CE mark allows the Company to market and sell the
CHEMOSAT Delivery System for Melphalan in Europe. In addition, the Company has
initiated plans to investigate the Melblez Kit for primary liver cancer. For
more information, please visit the Company's website at

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 Company's ability to satisfy
the requirements of the FDA's Complete Response Letter and provide the same in
a timely manner, adoption, use and resulting sales, if any, for the CHEMOSAT
system to deliver and filter melphalan in the EEA, our ability to successfully
commercialize the chemosaturation system and the potential of the
chemosaturation system as a treatment for patients with primary and metastatic
disease in the liver, market acceptance of the Gen Two CHEMOSAT system and
patient outcomes using the same, approval of the current or future
chemosaturation system for delivery and filtration of melphalan, doxorubicin
or other chemotherapeutic agents for various indications in the US and/or in
foreign markets, actions by the FDA or other foreign regulatory agencies, our
ability to successfully enter into strategic partnership and distribution
arrangements in foreign markets including Australia and key Asian markets and
timing and revenue, if any, of the same, the approval of the Hepatic CHEMOSAT
Delivery System device to deliver and filter doxorubicin in key Asian markets
and patient outcomes using the same, our ability to obtain reimbursement for
the CHEMOSAT system, uncertainties relating to the timing and results of
research and development projects, uncertainties relating to the timing and
results of 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 to
publicly update or revise these forward-looking statements to reflect events
or circumstances after the date they are made.

Contact Information:
Investors:                       Financial Media:
Michael Polyviou/Patty Eisenhaur John Carter
EVC Group                       EVC Group
(212) 850-6020/(951) 316-0577    (212) 850-6021


This announcement is distributed by Thomson Reuters on behalf of Thomson
Reuters clients.

The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and other
applicable laws; and
(ii) they are solely responsible for the content, accuracy and originality of
information contained therein.

Source: Delcath Systems, Inc via Thomson Reuters ONE
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