NEW
YORK, Feb. 16, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH), an interventional oncology
company focused on the treatment of primary and metastatic cancers
of the liver, announced that its Board of Directors has voted to
appoint John R. Sylvester as
Delcath's new Chairman. Mr. Sylvester has served as a Director of
Delcath since July 2019 and has
extensive experience building interventional oncology businesses,
most recently serving as Chief Executive Officer of both Curium's
SPECT and International business units. In addition, Mr. Sylvester
served as BTG plc's Chief Commercial Officer, leading both their
Interventional Oncology and Interventional Vascular businesses, as
well as BTG's Chief Development Officer accountable for Strategy,
M&A and Market access. His role at BTG culminated with
Boston Scientific's 2019 purchase of BTG for $4.2 billion. Mr. Sylvester also built
Biocompatibles International plc's Interventional Oncology
business, which BTG purchased for £166.0 million in 2010.
Dr. Roger Stoll, who has served
as Delcath's Chairman since October
2015 and has been a Delcath Director since December 2008, will continue to serve as an
active member of Delcath's Board of Directors and Committees.
"I look forward to my continued service as a Director at
Delcath. Given John's strong commercial background in
developing new markets, he is ideally suited to take the Board
leadership role at this time," said Dr. Stoll.
Gerard Michel, Delcath's CEO
stated, "We thank Roger for his many years of guidance and
leadership as the Company worked to secure approval for HEPZATO
Kit, and will value his continued contribution as an active member
of the Board. I look forward to partnering with John in his
new role and know that the Company will greatly benefit from his
extensive experience in commercializing innovative interventional
oncology products, as we prepare for launch in the US."
Mr. Sylvester stated, "I also want to thank Roger for his
leadership during the conduct of the FOCUS trial and the writing
and resubmission of the HEPZATO Kit NDA. The HEPZATO Kit is a
truly unique interventional oncology product which, if approved,
will offer unique advantages to healthcare professionals and
patients and I look forward to guiding the Company through its
planned growth."
About Delcath Systems, Inc.
Delcath Systems, Inc. is an interventional oncology company
focused on the treatment of primary and metastatic liver cancers.
The company's proprietary products, HEPZATO Kit (melphalan
hydrochloride for Injection/Hepatic Delivery System) and
CHEMOSAT® Hepatic Delivery System for Melphalan
percutaneous hepatic perfusion (PHP) are designed to administer
high-dose chemotherapy to the liver while controlling systemic
exposure and associated side effects during a PHP procedure.
In the United States, the
HEPZATO Kit is considered an investigational drug/device
combination product regulated as a drug by the United States Food
and Drug Administration (FDA). HEPZATO Kit is comprised of the
chemotherapeutic drug melphalan and Delcath's proprietary Hepatic
Delivery System (HDS). The HDS is used to surgically isolate
the liver while simultaneously filtrating hepatic venous blood
during melphalan infusion and washout. The use of the HDS results
in loco-regional delivery of a relatively high melphalan dose,
which can potentially induce a clinically meaningful tumor response
with minimal hepatotoxicity and reduce systemic exposure. In the
US, HEPZATO Kit was the subject of a February 14, 2023 new drug application
resubmission to FDA for the treatment of patients with unresectable
hepatic-dominant metastatic ocular melanoma (mOM), also known as
metastatic uveal melanoma (mUM). In Europe, the device-only configuration of the
HDS is regulated as a Class lll medical device and is approved for
sale under the trade name CHEMOSAT Hepatic Delivery System for
Melphalan, or CHEMOSAT, where it has been used in the conduct of
percutaneous hepatic perfusion procedures at major medical centers
to treat a wide range of cancers of the liver.
Safe Harbor/Forward-Looking Statements
The 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: actions by the FDA
relating to the application; the ability of the Company to respond
to FDA queries related to the application; the Company's successful
inspections by the FDA or foreign regulatory agencies; the timing
and results of the Company's clinical trials, our determination
whether to continue a clinical trial program or to focus on other
alternative indications, and the impact of the COVID-19 pandemic on
the completion of our clinical trials; the impact of the
presentations at major medical conferences and future clinical
results consistent with the data presented; the Company's ability
to successfully commercialize the HEPZATO Kit and the potential of
the HEPZATO Kit/CHEMOSAT system as a treatment for patients with
primary and metastatic disease in the liver; our ability to obtain
reimbursement for commercialized product in various markets; the
Company's ability to successfully enter into strategic partnership
and distribution arrangements and the timing and revenue, if any,
of the same; uncertainties relating to the timing and results of
research and development projects; 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.
Contact:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.