NEW YORK, April 13, 2011 /PRNewswire/ — Delcath Systems, Inc.
DCTH) today announced that the Company has been notified of CE
Mark approval for its proprietary Hepatic CHEMOSAT™ Delivery
System. The product has been approved with an indication for the
percutaneous intra-arterial administration of a chemotherapeutic
agent (melphalan hydrochloride) to the liver.
CE Marking confirms that a medical device complies with the
Essential Requirements of the Medical Device Directive, and that
the device has been subjected to conformity assessment procedures.
Receipt of the CE Mark allows Delcath to market and sell the
product in countries in the European Economic Area.
“Receipt of our CE Mark represents the first regulatory approval
for this product, and marks the beginning of the Company’s
transition into a fully commercial enterprise,” said Eamonn P.
Hobbs, CEO & President of Delcath Systems. “With its rising
liver cancer rates, Europe represents a large opportunity for this
product. We believe the Hepatic CHEMOSAT Delivery System may
ultimately fulfill an annual unmet clinical need for as many as
100,000 liver cancer patients in this region. With the CE
Mark in hand, we will now begin to build inventory and establish
the commercialization infrastructure in Europe, including
assembling a direct sales organization to cover countries in
Northern Europe and establishing a network of third party
distributors in Southern Europe. We will also begin establishing
and training initial sites in select European countries as Centers
of Clinical Excellence for the chemosaturation procedure.”
About Delcath SystemsDelcath 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 o