NEW YORK, May 31, 2016 /PRNewswire/ -- Delcath
Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and
medical device company focused on oncology with an emphasis on the
treatment of primary and metastatic liver cancers, announces that
Company management will participate at the 6th Annual LD
Micro Invitational taking place from June
7-9, 2016 in Los Angeles.
Jennifer K. Simpson, Ph.D., MSN,
CRNP, President and Chief Executive Officer of Delcath, will
present a corporate overview on June
8th at 12:30 p.m. Pacific
time.
Dr. Simpson's presentation at the LD Micro Invitational will be
webcast live and will be archived on the Company's website at
www.delcath.com.
About Delcath Systems
Delcath Systems, Inc. is a specialty pharmaceutical and
medical device company focused on oncology with a principal focus
on the treatment of primary and metastatic liver cancers. Our
proprietary 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. In April 2012 we obtained
authorization to affix a CE Mark to our second-generation system,
which is currently marketed in Europe as a device under
the trade name Delcath Hepatic CHEMOSAT® Delivery System for
Melphalan (CHEMOSAT). In the U.S. the Melphalan/HDS system is
considered a combination drug and device product, and is regulated
as a drug by the U.S. Food and Drug Administration (FDA).
Melphalan/HDS has not been approved for sale in the U.S. We have
commenced our 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).
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 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, approval of
Individual Funding Requests for reimbursement of the CHEMOSAT
procedure, 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 or other chemotherapeutic agents 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.
Investor Contact:
Anne Marie
Fields
LHA
212-838-3777
afields@lhai.com
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SOURCE Delcath Systems, Inc.