NEW YORK –
Delcath Systems, Inc. (NASDAQ: DCTH), an interventional oncology Company
focused on developing safe and effective treatments for primary and
metastatic liver cancers, announces that results from two
single-institution studies conducted in Germany of use of the Delcath
Hepatic CHEMOSAT® Delivery System to treat patients with liver
metastases were presented as posters at the Cardiovascular and
Interventional Radiology Society of Europe (CIRSE) annual meeting.

The first study, Secondary Resectability of Ocular Melanoma Liver
Metastases (OMLM) Following Percutaneous Hepatic Perfusion (PFP) by
M. Zeile, et al. of the Asklepios Barmbek Clinic in Hamburg,
Germany, evaluated 7 patients with unresectable ocular melanoma liver
metastases treated with CHEMOSAT. There were 12 CHEMOSAT procedures
administered in total, with a median of 2 cycles per patient, and a
range of 1 to 3. The objective response rate after 1-2 treatments was
71.4%. Two patients showed secondary resectability on imaging after
completing two treatments and remain alive for over 26 months following
resections. Progression free survival was 9.9 months and hepatic
progression free survival was 11.2 months. Median survival for the study
has not yet been reached, but is higher than 16.9 months. There were no
adverse events of grade 3 or higher. Investigators concluded that
CHEMOSAT is safe to use in these patients and that significant
downsizing of ocular melanoma liver metastases can be achieved with
CHEMOSAT. These researchers concluded that if these promising results
were further validated it “may lead to a new standard of therapy for the
treatment of patients with ocular melanoma liver metastases.”

The second study, Percutaneous Isolated Hepatic Perfusion
(Chemosaturation) In Patients With Primary Or Secondary Liver Tumours:
Experience In 20 Patients, by S. Marquardt et al., of Hanover
Medical School in Hanover, Germany, retrospectively evaluated patients
with advanced disease from primary or metastatic cancers of the liver.
The local response rate (stable disease or partial response) was 80%.
Mean progression free survival was 3.2 months. The investigators
reported no major complications and that bone marrow suppression was
common but controllable. The investigators concluded that patients with
primary or secondary liver tumors that have disease progression under
standard therapy “may profit from PHP with Melphalan,” that technical
execution is problem-free, and complications are manageable.

We are very pleased with the results of these studies, which both show
noteworthy results achieved with CHEMOSAT in difficult to treat patients
with few effective options,” said Jennifer K. Simpson, Ph.D., MSN, CRNP,
President and Chief Executive Officer of Delcath. “These
single-institution studies add to the growing body of research that
support a significant role for CHEMOSAT in the management of patients
with cancers of the liver.”

The CIRSE conference is being held in Barcelona, Spain at the Centre de
Convencions Internacional de Barcelona from September 10-14, 2016.
Additional information for the CIRSE Scientific Program is available here.

About Delcath Systems

Delcath Systems, Inc. is an interventional oncology Company focused on
the treatment of primary and metastatic liver cancers. Our
investigational product-Melphalan Hydrochloride for Injection for use
with the Delcath Hepatic Delivery System (Melphalan/HDS) -is designed to
administer high-dose chemotherapy to the liver while controlling
systemic exposure and associated side effects. We have commenced a
global Phase 3 FOCUS clinical trial for Patients with Hepatic Dominant
Ocular Melanoma (OM) and a global Phase 2 clinical trial in Europe and
the U.S. to investigate the Melphalan/HDS system for the treatment of
primary liver cancer (HCC) and intrahepatic cholangiocarcinoma (ICC).
Melphalan/HDS has not been approved by the U.S. Food & Drug
Administration (FDA) for sale in the U.S. In Europe, our system has been
commercially available since 2012 under the trade name Delcath Hepatic
CHEMOSAT® Delivery System for Melphalan (CHEMOSAT), where it has been
used at major medical centers to treat a wide range of cancers of the
liver.

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:
our ability to repay and comply with the obligations under our senior
secured convertible notes, the timing and results of the Company’s clinical
trials including without limitation the OM, HCC ,and ICC clinical
trial programs, timely enrollment and treatment of patients in
the global Phase 3 FOCUS Clinical Trial for Patients with Hepatic
Dominant Ocular Melanoma and the global Phase 2 HCC and ICC clinical
trials, IRB or ethics committee clearance of the Phase 2 HCC/ICC and/or
Phase 3 OM protocols from participating sites and the
timing of site activation and subject enrollment in each trial, the
impact, if any, of publication of the Phase 3 trial manuscript to
support the Company’s efforts, the impact of the presentations at major
medical conferences and future clinical results consistent with the data
presented, the impact, if any of ZE reimbursement on potential
CHEMOSAT product use and sales in Germany, clinical adoption, use and
resulting sales, if any, for the CHEMOSAT system to deliver and filter
melphalan in Europe, the Company’s ability to successfully commercialize
the CHEMOSAT/Melphalan HDS system and the potential of the
CHEMOSAT/Melphalan HDS system as a treatment for patients with primary
and metastatic disease in the liver, our ability to obtain reimbursement
for the CHEMOSAT system in various markets, the Company’s ability to
satisfy the remaining requirements of the FDA’s Complete Response Letter
and provide the same in a timely manner, approval of the current or
future Melphalan HDS/CHEMOSAT system for delivery and filtration of
melphalan for various indications in the U.S. and/or in foreign markets,
actions by the FDA or other foreign regulatory agencies, the Company’s
ability to successfully enter into strategic partnership and
distribution arrangements in foreign markets and the timing and revenue,
if any, of the same, uncertainties relating to the timing and results of
research and development projects, our ability to maintain NASDAQ
listing, and uncertainties regarding the Company’s ability to obtain
financial and other resources for any research, development, clinical
trials 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.

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LHA
Investor Contact:
Anne Marie Fields, 212-838-3777
afields@lhai.com