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): February 1, 2007
DELCATH SYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 001-16133 06-1245881
(State or other jurisdiction of Commission File (IRS Employer
incorporation) Number) 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 changed 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 5 - Corporate Governance and Management
Item 5.02 Departure of Directors or Certain Officers; Election of Directors;
Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
(a) Not applicable.
(b) Not applicable.
(c) Not applicable.
(d) Not applicable.
(e) At a meeting of the Compensation and Stock Option Committee of the
Board of Directors of Delcath Systems, Inc. (the "Company") on February 1, 2007,
the Committee approved an increase in the monthly compensation payable to
Richard Taney, the Company's Chief Executive Officer, from $20,000 to $30,000.
(f) Not applicable.
Section 8- Other Events
Item 8.01 Other Events.
Appointment of Chairman
On February 2, 2007 the Company issued a press release announcing that
Harold S. Koplewicz, M.D. had been appointed Chairman of the Company's Board of
Directors at the meeting of the Board held on February 1, 2007.
Further information concerning Dr. Koplewicz is contained in the Company's
press release dated February 2, 2007, a copy of which is filed as Exhibit 99
hereto and which is incorporated herein by reference.
Settlement of Litigation
In addition, the Company announced in its February 2, 2007 press release
that it had settled its lawsuit against Jonathan A. Foltz, the Company's former
Director of Operations. The settlement provides for mutual releases of claims
and for the Company to pay a portion of Mr. Foltz's attorneys fees.
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Filter Technology and Evaluation
On February 5, 2007 Delcath was informed of a voluntary commercial filter
recall by its current filter manufacturer due to issues concerning sterility
assurance. However, both because the Company's use of these filters is
investigational rather than commercial and because the FDA approved protocols
for the Company's clinical trials require filter sterilization at each study
center as part of the procedure, the commercial recall will not prevent the
Company from continuing its clinical trials currently in progress. In addition,
in response to a request from the Food and Drug Administration and in an effort
to further characterize the performance attributes of its current filters,
Delcath had already begun a series of detailed testing protocols with a number
of recognized filter testing laboratories. This comprehensive testing program
will establish a more complete set of baseline empirical data for our current
filters and provide the basis for comparative evaluations of new filters from
alternative suppliers. The Company is taking a number of steps to assess its
current filter and catheter technologies and has embarked on an active program
of research and development with leading hemo-filtration technology companies.
The objectives of this initiative are to improve and enlarge the Company's
intellectual property position and to develop novel filter technologies to
optimize performance and enable expanded clinical applications. The ongoing
filter testing program will both support the continued use of the current
filters in Delcath's clinical studies and provide a reference standard for the
development and assessment of new filters and filtration technologies.
Section 9 - Financial Statements and Exhibits.
Item 9.01. Financial Statements and Exhibits.
(a) Not applicable.
(b) Not applicable.
(c) Not applicable.
(d) Exhibits:
Exhibit Description
99 Press Release dated February 1, 2007 of Delcath Systems,
Inc.
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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/ RICHARD TANEY
---------------------------
Richard Taney
Chief Executive Officer
Date: February 7, 2007
EXHIBIT INDEX
Exhibit Description
99 Press Release dated February 1, 2007 of Delcath Systems,
Inc.
[GRAPHIC OMITTED]
Company Contact: Investor Contacts:
Delcath Systems, Inc. Todd Fromer / Garth Russell
Richard Taney KCSA Worldwide
203-323-8668 (212) 896-1215 / (212) 896-1250
www.delcath.com tfromer@kcsa.com / grussell@kcsa.com
- --------------- ---------------- -----------------
Media Contact:
Lewis Goldberg
KCSA Worldwide
(212) 896-1216
lgoldberg@kcsa.com
- ------------------
FOR IMMEDIATE RELEASE
Delcath Elects Dr. Harold Koplewicz
Chairman of the Board of Directors
- - -
Delcath Settles Litigation Against Former Director of Operations
STAMFORD, Conn., February 2, 2007 -- Delcath Systems, Inc. (NASDAQ: DCTH)
announced today that Harold S. Koplewicz, M.D. was appointed Chairman of the
Board of Directors at its meeting on Thursday, February 1, 2007. Dr. Koplewicz,
54, was initially appointed as an independent director of Delcath's Board in
September 2006.
"I am honored that the Board has selected me to be Delcath Systems' new
Chairman," stated Dr. Koplewicz. "Delcath has a fresh new outlook for moving
forward and the Board is taking on a more aggressive strategy to advance the
company." He added, "In earlier clinical trials, the Delcath system has shown
tremendous potential as an effective therapy for inoperable liver cancer.
Considering there is currently no effective therapy for inoperable liver cancer,
where patients have an average life expectancy of less than nine months, there
is an immediate real-world need for our technology and we need to move ahead
with a greater sense of urgency."
Richard Taney, CEO of Delcath Systems, stated, "Since joining the Board, Harold
has proven to be an excellent resource for Delcath. Through his association with
some of the country's premier medical centers along with his established
relationships with other leading medical professionals, Harold will help us in
our effort to recruit additional sites for the Phase III Melphalan trial and
explore additional applications for our intellectual property."
In addition, Delcath announced that it has settled its lawsuit against Mr.
Jonathan Foltz, the former Director of Operations of Delcath. Mr. Taney stated,
"The company is pleased that this matter has been satisfactorily resolved as we
continue to refocus our energies on our primary mission of obtaining regulatory
approval for the Delcath system."
About Harold S. Koplewicz, M.D.
Dr. Koplewicz was appointed by Governor George Pataki to the position of
Executive Director of the Nathan S. Kline Institute for Psychiatric Research
(NKI), one of only two research hospitals funded by New York State in May 2006.
He is only the third person to hold this prestigious title since 1952. Dr.
Koplewicz is also currently the Arnold and Debbie Simon Professor and Chairman
of the Department of Child and Adolescent Psychiatry and Professor of Pediatrics
and founder of the NYU Child Study Center at the New York University School of
Medicine.
Castle Connolly Medical, an extensive survey of thousands of physicians each
year, and New York Magazine have repeatedly named Dr. Koplewicz as one of
America's Top Doctors. He is a nationally renowned child and adolescent
psychiatrist, who regularly appears on national media, including The Today Show,
National Public Radio, Good Morning America, LIVE with Regis and Kelly, Oprah,
The View, CNN American Morning, CNN Weekend Housecalls, NBC Nightly News, ABC
World News Tonight and Dateline NBC.
He has served as a member of the National Board of Medical Examiners and as a
commissioner of the New York State Commission on Youth, Crime and Violence and
Reform of the Juvenile Justice System.
About Delcath Systems, Inc.
Delcath Systems is a developer of isolated perfusion technology for organ or
region-specific delivery of therapeutic agents. The Company's intellectual
property portfolio currently consists of 12 patents on a worldwide basis,
including the United States, Europe, Asia and Canada. For more information,
please visit the Company's website, www.delcath.com.
This 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 our ability to successfully complete Phase
III clinical trials and secure regulatory approval of our current or future
drug-delivery system 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.
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