Delcath Submits CE Mark Technical File For Hepatic ChemoSAT™ Delivery System

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Delcath Submits CE Mark Technical File For Hepatic ChemoSAT™

Delivery System

07 Dec 2010   

Delcath Systems, Inc. (Nasdaq: DCTH) announced that the Company has

submitted its CE Mark Technical File to its European Notified Body

to obtain CE Mark approval for its proprietary chemosaturation

system, which the Company intends to market in the European Union

(EU) as the Delcath Hepatic ChemoSAT™ Delivery System. CE Marking is

an indication that a medical device complies with the essential

requirements of applicable medical device directives, and that the

device has been subjected to conformity assessment procedures.

Receipt of the CE Mark will allow Delcath to market and sell the

product in countries in the EU.

"The EU represents an attractive opportunity for this product," said

Eamonn P. Hobbs, CEO & President of Delcath Systems. "Our filing

in the EU is seeking an indication for the percutaneous

intra-arterial administration of a chemotherapeutic agent (melphalan

hydrochloride) to the liver. With the EU's aging population and

liver cancer rates on the rise we believe the Hepatic ChemoSAT

Delivery System will fulfill an unmet clinical need for many liver

cancer patients in this region. With the submission of our Technical

File, and successful completion of the audits of our quality system

and manufacturing facility, we expect potential CE Mark approval in

mid-2011."

"With respect to U.S. regulatory status, we continue to expect to

submit the remaining modules of our New Drug Application (NDA) to

the U.S. Food and Drug Administration (FDA) by the end of 2010, and

will make additional announcements as we progress," added Mr. Hobbs.

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 the acceptability of

the Phase III clinical trial data by the FDA, our ability to

successfully complete an FDA new drug application(NDA), acceptance

of the Company's NDA by the FDA, acceptance of the Company's CE

Mark Technical File by its Notified Body, receipt of CE Mark

approval, adoption, use and resulting sales in the EU, if any,

approval of the Company's NDA by the FDA or other regulatory

authorities of the current or future drug delivery system for the

treatment of metastatic melanoma, the potential of the

chemosaturation system as a treatment for patients with terminal

metastatic disease in the liver, actions by the FDA or other

regulatory agencies, our ability to successfully enter into

distribution and strategic partnership agreements in foreign

markets and the corresponding revenue associated with such foreign

markets, 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.

Source: Delcath Systems, Inc

Article URL: http://www.medicalnewstoday.com/articles/210483.php

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Bill Eastman

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