Unassociated Document
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 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): May 12, 2008
ARBIOS
SYSTEMS, INC.
(Exact
Name of Registrant as Specified in its Charter)
Delaware
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000-32603
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91-1955323
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(State
or other
jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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1050
Winter Street, Suite 1000, Waltham, Massachusetts, 02451
(Address
of Principal Executive Offices) (Zip Code)
(781)
839-7292
(Registrant’s
Telephone Number, Including Area Code)
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):
o Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
o Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
ITEM
7.01 Regulation FD Disclosure.
On
May
12, 2008, Arbios Systems, Inc. (the “Company”) announced that
the
Company received approval from the U.S. Food and Drug Administration of an
Investigational Device Exemption to begin the pivotal clinical trial for SEPET™,
the Company’s extracorporeal (outside the body) liver assist device for blood
purification of chronically ill patients suffering from acute liver failure.
We
anticipate that a significant capital raise is necessary in order to continue
operations and development of planned products, including the
development of SEPET™ and the commencement of the SEPET™ pivotal
trial.
A
copy of
the press release announcing the approval is attached as Exhibit 99.1 to this
report and is incorporated by reference.
ITEM
9.01 Financial Statements And Exhibits.
(d)
Exhibits.
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Exhibit No.
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Exhibit
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99.1
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Press
Release dated May 12, 2008.
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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.
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ARBIOS
SYSTEMS, INC.
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Date: May
12,
2008 |
By: |
/s/ SHAWN
P.
CAIN |
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Shawn
P. Cain, Interim President and Chief Executive Officer
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EXHIBIT
INDEX
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Exhibit No.
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Exhibit
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99.1
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Press
Release dated May 12, 2008.
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