<SEC-DOCUMENT>0001341004-12-000160.txt : 20120202
<SEC-HEADER>0001341004-12-000160.hdr.sgml : 20120202
<ACCEPTANCE-DATETIME>20120202172324
ACCESSION NUMBER:		0001341004-12-000160
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20120202
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120202
DATE AS OF CHANGE:		20120202

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			DELCATH SYSTEMS INC
		CENTRAL INDEX KEY:			0000872912
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				061245881
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-16133
		FILM NUMBER:		12566900

	BUSINESS ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
		BUSINESS PHONE:		212-489-2100

	MAIL ADDRESS:	
		STREET 1:		810 SEVENTH AVENUE
		STREET 2:		FL 35
		CITY:			NEW YORK
		STATE:			NY
		ZIP:			10019
</SEC-HEADER>
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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">CURRENT REPORT</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Date of report (Date of earliest event reported): <font style="DISPLAY: inline; FONT-WEIGHT: bold">February 2, 2012</font></font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Item 8.01. Other Events.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">On February 2, 2012, Delcath Systems, Inc. (the "Company") issued a press release announcing that the first patients in Europe have been treated with the Delcath Hepatic CHEMOSAT&#174; Delivery System at the European Institute of Oncology (Instituto Europeo di Oncologia &#8211; IEO), a premier cancer treatment and research center in Milan.&#160;&#160;A copy of the press release is filed as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font size="3">In addition, the Company is currently negotiating the terms of a $20 million credit facility.&#160; The Company expects to enter into a definitive agreement with a commercial bank in the first quarter of 2012.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Item 9.01.&#160;&#160;Financial Statements and Exhibits.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The following exhibits are filed herewith:</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: times new roman, serif; FONT-SIZE: 12pt">Press Release of Delcath Systems, Inc., dated February 2, 2012</font></div>
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<div style="LINE-HEIGHT: 17.15pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Procedures Conducted At European Institute of Oncology Signals Significant Step Forward In Commercialization of the CHEMOSAT Delivery System to Treat Cancers in the Liver</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">NEW YORK, February 2, 2012 &#8211; <font style="DISPLAY: inline">Delcath Systems, Inc. (NASDAQ: DCTH) announced today that the first patients in Europe have been treated with the </font>Delcath Hepatic CHEMOSAT<font style="DISPLAY: inline; FONT-SIZE: 70%; VERTICAL-ALIGN: text-top">&#174;</font> Delivery System at the European Institute of Oncology (Instituto Europeo di Oncologia &#8211; IEO), a premier cancer treatment and research center in Milan. The cases were treated as part of the initial launch and training agreement the Company announced with the IEO in November 2011.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Two patients were treated for inoperable liver-dominant metastases from ocular melanoma and gastric cancer. All CHEMOSAT procedures were successfully completed without procedure-related complications. Delcath and the IEO will host a joint-press conference, on February 15, 2012 at the IEO, at which time an update on patient status will be presented.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The procedures were conducted with the Generation One version of the CHEMOSAT system, while the Generation Two version is under review for CE Mark approval by the Notified Body.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">"The CHEMOSAT system represents an important advancement in treatment options for cancers in the liver, which have significantly poorer survival rates compared to cancers that have spread predominantly to other organs," said Dr. Alessandro<font style="DISPLAY: inline"> Testori, a surgical oncologist and Director of the Division of Melanoma and Skin-Muscle Sarcoma at the IEO. "We believe this technology will help fill an important gap in the treatment of multiple tumor types in the liver because of its demonstrated ability to deliver concentrated doses of chemotherapeutic agent directly to the liver while helping to minimize systemic exposure. We are pleased to be the first center in Europe to begin offering this treatment to patients and look forward to exploring its potential with Delcath."</font></font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt"><font style="DISPLAY: inline">CHEMOSAT</font> <font style="DISPLAY: inline">is a proprietary product that utilizes chemosaturation technology, a minimally invasive, repeatable procedure that delivers high doses of </font>chemotherapeutic drugs directly to the liver while minimizing systemic exposure of such drugs. <font style="DISPLAY: inline">CHEMOSAT received CE Mark in April 2011 as a Class III medical device with an indication for the percutaneous intra-arterial administration of a chemotherapeutic agent (melphalan hydrochloride) to the liver.</font></font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">"Since obtaining our CE Mark, Delcath has been committed to supporting the technology in the substantial international liver cancer market,&#8221; said Eamonn P. Hobbs, President and CEO of Delcath. &#8220;These cases represent the first uses of CHEMOSAT outside of a clinical trial&#8212;an exciting milestone for Delcath. There is no greater endorsement for CHEMOSAT than to have the first European patients treated at an organization as prestigious as the IEO. We are delighted that the procedures were successfully performed, and look forward to continued collaborative</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">progress with the IEO and the opportunity to open additional CHEMOSAT treatment centers across Europe."</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">About the IEO</font></font></div>

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<div style="LINE-HEIGHT: 14.4pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">The European Institute of Oncology was established in 1994 to implement an innovative model for health and advanced research in the international oncology field. The IEO's mission is focused on state-of-the-art cancer research and treatment, from basic laboratory research that grapples with the genetic roots of cancer, to advanced clinical research such as testing new drugs, all with the unifying goal of finding ways to treat patients more effectively.</font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="FONT-STYLE: italic; DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt; FONT-WEIGHT: bold"><font style="DISPLAY: inline; TEXT-DECORATION: underline">About Delcath Systems</font></font></div>

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<div style="LINE-HEIGHT: 13.7pt; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman, serif; FONT-SIZE: 12pt">Delcath Systems, Inc. is a development-stage 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 organs or regions of the body, while controlling the systemic exposure of those agents. The Company's initial focus is on the treatment of primary and metastatic liver cancers. In 2010, Delcath concluded a Phase III metastatic melanoma study, and the Company recently completed a multi-arm Phase II trial to treat other liver cancers. The Company obtained authorization to affix a CE Mark for the Hepatic CHEMOSAT delivery system in April 2011. The Company has not yet received FDA approval for commercial sale of its system in the United States. For more information, please visit the Company's website at <font style="DISPLAY: inline; TEXT-DECORATION: underline">http://www.delcath.com/</font>.</font></div>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
