NEW
YORK, June 7, 2023 /PRNewswire/ -- Delcath
Systems, Inc. (Nasdaq: DCTH) (the "Company" or "Delcath"), an
interventional oncology company focused on the treatment of primary
and metastatic cancers of the liver, is pleased to announce that
the Company has appointed Sandra Pennell as its new Senior
Vice President of Finance. Ms. Pennell will also serve as an
Executive Officer of the Company and its Principal Accounting
Officer and Principal Financial Officer.
Ms. Pennell joins the Company with over twenty-years of
experience in a variety of financial oversight roles within the
biotechnology industry and she will be responsible for managing all
the Company's financial affairs, including preparing global
financial statements for the guidance of management in accordance
with U.S. Generally Accepted Accounting Principles (GAAP).
She will lead the Company's financial team as the Company prepares
to transition into a commercial organization.
Ms. Pennell previously held the position of Vice President,
Finance at Invivyd, Inc. and prior to that she was a Vice
President, Corporate Controller, and Principal Accounting Officer
at Vericel Corporation. Sandra earned a Bachelor and Master of
Science in Accountancy from University of
Illinois at Urbana-Champaign.
"We are pleased to welcome Sandra to the Delcath management
team," said Gerard Michel, Chief Executive Officer. "Given her
experience in rapidly growing commercial companies she is well
positioned to manage Delcath's financial operations and strategy as
we approach the possible commercialization of the HEPZATO Kit
in the US."
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,
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). FDA has established an August 14,
2023 Prescription Drug User Fee Act (PDUFA) date for the
resubmission. In Europe, the
device-only configuration of the HDS is regulated as a Class III
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.
Contact:
Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com
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SOURCE Delcath Systems, Inc.