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DELCATH, SKY RIDGE MEDICAL CENTER INITIATE U.S. EXPANDED ACCESS PROGRAM



2013-01-09 21:11:32 -


EAP Provides U.S. Patients Access to Second-Generation Hemofiltration Cartridge
Currently Under Active FDA Review
NEW YORK, Jan. 9, 2013 -- Delcath Systems, Inc. (NASDAQ: DCTH) today announced
that Sky Ridge Medical Center in Lone Tree, Colo., has become the first U.S.
center to initiate the Expanded Access Program (EAP), which will provide
eligible patients access to treatment with the Company's second-generation
hemofiltration cartridge of its proprietary chemosaturation system.  The
Company's New Drug Application (NDA) is currently under review by the U.S. Food
and Drug Administration (FDA) for the treatment of patients with unresectable
metastatic ocular melanoma in the liver with a PDUFA goal date of June 15, 2013.

Under certain circumstances, the FDA allows companies to offer early access
programs to patients who have serious or immediately life-threatening illnesses
for which there are no comparable alternative therapies. Sky Ridge Medical
Center, an American College of Surgeons (ACoS) accredited cancer center, is the
first of several prestigious U.S. medical centers expected to offer eligible
patients access to the treatment option under the Delcath EAP program.

"Patients with unresectable metastatic ocular melanoma in the liver often have
few choices with regard to treatments," said Dr. Charles W. Nutting, an
interventional radiologist with Sky Ridge Medical Center. "Liver involvement is
a life-limiting factor for these patients. We believe the expanded access
program provides patients an important access to treatment that could
potentially be beneficial."

"As an investigator in our Phase 3 clinical trial, Dr. Nutting has been a
pioneer in the development of chemosaturation therapy, and we are pleased that
Sky Ridge Medical Center is participating in our EAP under his leadership" said
Eamonn P. Hobbs, President & CEO of Delcath Systems.   "The EAP is a beneficial
program offered by the FDA that provides patients with limited treatment options
the opportunity to access drugs that are still in investigational stages. We
felt it was important to pursue EAP approval for our chemosaturation system with
the Generation Two filter because many of the patients with metastatic melanoma
cannot wait while our New Drug Application is under review by the FDA."

"Dr. Nutting and his Interventional Radiology team at Sky Ridge have led the way
in advancing this and other life enhancing treatments for patients," said
Maureen Tarrant, CEO of Sky Ridge Medical Center.  "As a destination center for
high quality, compassionate care, we are proud of Dr. Nutting's leadership,
innovation and commitment to our oncology program."

About Sky Ridge Medical Center

As Douglas County, Colorado's first hospital, Sky Ridge Medical Center opened on
August 20, 2003 and has since become a destination center for healthcare,
providing a depth and breadth of quality services and advanced treatment options
to the region. Sky Ridge has earned not only quality designations from the Joint
Commission and other governing bodies but has earned high marks for patient
satisfaction. Sky Ridge Medical Center is a member of the HealthONE system of
excellence, which includes seven hospitals; three surgery centers; more than 30
occupational medicine/rehabilitation, specialty clinics; and AirLife, which
provides critical care air and ground transportation for the HealthONE system.
More information can be found online at www.skyridgemedcenter.com.
About Delcath Systems

Delcath Systems, Inc. is a 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 announced that its randomized Phase
3 clinical trial for patients with metastatic melanoma in the liver had
successfully achieved the study's primary endpoint of extended hepatic
progression-free survival. The Company also completed a multi-arm Phase 2 trial
to treat other liver cancers. The Company obtained authorization to affix a CE
Mark for the Generation Two CHEMOSAT® delivery system for melphalan
hydrochloride in April 2012.  The right to affix the CE mark allows the Company
to market and sell the CHEMOSAT system for melphalan hydrochloride in Europe. In
October 2012, the Company satisfied all of the requirements to affix the CE Mark
to the Hepatic CHEMOSAT Delivery System device for intra-hepatic arterial
delivery and extracorporeal filtration of doxorubicin hydrochloride injection,
providing a regulatory pathway for the CHEMOSAT Delivery System to deliver and
filter doxorubicin for countries in Asia that accept the CE Marking as part of
their national regulatory requirements.  The Company has not yet received FDA
approval for commercial sale of its system in the United States. The Company's
NDA has been accepted for filing and substantive review by the FDA.  For more
information, please visit the Company's website at www.delcath.com.

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: patient outcomes using the chemosaturation system
in the EAP,  timing of completion of the FDA's review of our NDA, the extent to
which the FDA may request additional information or data and our ability to
provide the same in a timely manner, acceptability of the Phase 1, 2 and 3
clinical trial data by the FDA, FDA approval of the Company's NDA for the
treatment of ocular metastatic melanoma to the liver, adoption, use and
resulting sales, if any, in the United States, 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 an 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:


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