UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 30, 2004 DELCATH SYSTEMS, INC. (Exact name of registrant as specified in its charter) Delaware 001-16133 06-1245881 (State or other jurisdiction (Commission File Number) (IRS Employer of incorporation) Identification No.) 1100 Summer Street, Stamford, Connecticut 06905 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (203) 323-8668 N/A (Former name or former address, if changes since last report) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 2 Section 8 - Other Events Item 8.01 Other Events. On September 30, 2004, Delcath Systems, Inc. (the "Company") issued a press release relating to the commencement at the National Cancer Institute of a Phase II clinical trial using the Company's technology to deliver high dosages of melphalan for patients with inoperable cancers in the liver. The Company's press release dated September 30, 2004 is incorporated herein by reference and filed as an exhibit hereto. Section 9 - Financial Statements and Exhibits Item 9.01. Financial Statements and Exhibits. (a) Not applicable (b) Not applicable. (c) Exhibits: Exhibit Description 99 Press Release dated September 30, 2004 of Delcath Systems, Inc. 3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DELCATH SYSTEMS, INC. By: /s/ M. S. KOLY ----------------------- President and Chief Executive Officer Date: September 30, 2004 EXHIBIT INDEX Exhibit Description 99 Press Release dated September 30, 2004 of Delcath Systems, Inc.