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<SEC-DOCUMENT>0001178913-09-000519.txt : 20090302
<SEC-HEADER>0001178913-09-000519.hdr.sgml : 20090302
<ACCEPTANCE-DATETIME>20090302095802
ACCESSION NUMBER:		0001178913-09-000519
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20090302
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090302
DATE AS OF CHANGE:		20090302

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			PLURISTEM THERAPEUTICS INC
		CENTRAL INDEX KEY:			0001158780
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				980351734
		STATE OF INCORPORATION:			NV
		FISCAL YEAR END:			0630

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-31392
		FILM NUMBER:		09645605

	BUSINESS ADDRESS:	
		STREET 1:		MATAM ADVANCED TECHNOLOGY PARK
		STREET 2:		BUILDING NO. 20
		CITY:			HAIFA
		STATE:			L3
		ZIP:			31905
		BUSINESS PHONE:		972-4-850-1080

	MAIL ADDRESS:	
		STREET 1:		MATAM ADVANCED TECHNOLOGY PARK
		STREET 2:		BUILDING NO. 20
		CITY:			HAIFA
		STATE:			L3
		ZIP:			31905

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	PLURISTEM LIFE SYSTEMS INC
		DATE OF NAME CHANGE:	20030701

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AI SOFTWARE INC
		DATE OF NAME CHANGE:	20010906
</SEC-HEADER>
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<TYPE>8-K
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     <!-- Control Number: 96468                                                            -->
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     <!-- Project Name:   8-K                                                              -->
     <!-- Firm Name:      Zadok-Keinan Ltd                                                 -->
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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=3>UNITED STATES </FONT><BR>
<FONT FACE="Times New Roman, Times, Serif" SIZE=4>SECURITIES AND
EXCHANGE COMMISSION </FONT><BR>
<FONT FACE="Times New Roman, Times, Serif" SIZE=2>Washington, DC 20549 </FONT></H1>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=4>Form&nbsp;8-K </FONT></H1>

<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><B>Current Report
<BR>Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934</B> </FONT></P>


<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2">Date of report (Date of earliest event reported): <B>March 2, 2009</B> </FONT></P>

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<P ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE="5"><B>PLURISTEM THERAPEUTICS
INC.</B> </FONT> <BR>
<FONT FACE="Times New Roman, Times, Serif" SIZE=2>(Exact name of
registrant as specified in its charter) </FONT></P>

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     <TD WIDTH=33% ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>Nevada</B> </FONT></TD>
     <TD WIDTH=34% ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>001-31392</B> </FONT></TD>
     <TD WIDTH=33% ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>98-0351734</B> </FONT></TD></TR>
<TR VALIGN=Bottom>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE=2>(State or other jurisdiction of incorporation)</FONT></TD>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE=2>(Commission file number)</FONT></TD>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE=2>(I.R.S. Employer Identification Number)</FONT></TD></TR>
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     <TD WIDTH=50% ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>MATAM Advanced Technology Park</B> </FONT></TD>
     <TD WIDTH=50% ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>&nbsp;</B> </FONT></TD></TR>
<TR VALIGN=Bottom>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>Building No. 20</B> </FONT></TD>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>&nbsp;</B> </FONT></TD></TR>
<TR VALIGN=Bottom>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>Haifa, Israel</B> </FONT></TD>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE="2"><B>31905</B> </FONT></TD></TR>
<TR VALIGN=Bottom>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE=2>(Address of principal executive offices)</FONT></TD>
     <TD ALIGN=CENTER><FONT FACE="Times New Roman" SIZE=2>(Zip Code)</FONT></TD></TR>
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     <TD></TD>
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<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2">Registrant's telephone number, including area code: <B>011 972 74 710 7171</B> </FONT></P>

<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><B>N/A
</B><BR>(Former name or former address, if changed since last report) </FONT></P>



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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Check
the appropriate box below if the Form&nbsp;8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following provisions: </FONT></P>

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</font> </FONT></TD>
<TD WIDTH=90%><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)</FONT></TD>
</TR>
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<BR>

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<TD WIDTH=5%><FONT FACE="Times New Roman, Times, Serif" SIZE=2>     <FONT size="3" face="Wingdings">o
</font> </FONT></TD>
<TD WIDTH=90%><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)</FONT></TD>
</TR>
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<BR>

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</font> </FONT></TD>
<TD WIDTH=90%><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))</FONT></TD>
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</font> </FONT></TD>
<TD WIDTH=90%><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))</FONT></TD>
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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Item 8.01 Other Events. </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>On March 2, 2009, the registrant
issued a press release announcing that the US Food &amp; Drug Administration has cleared
the registrant&#146;s Investigational New Drug application to initiate a Phase I clinical
trial for the treatment of critical limb ischemia using its PLX-PAD product. A copy of the
Press Release is attached hereto as Exhibit 99.1 and incorporated by reference herein. </FONT></P>

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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Item 9.01 Financial
Statements and Exhibits. </FONT></H1>

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<P ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>(d) Exhibits </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>99.1 Press release issued by the
registrant on March 2, 2009. </FONT></P>

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<H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>SIGNATURES </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;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. </FONT></P>


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<TD WIDTH=40%><FONT FACE="Times New Roman, Times, Serif" SIZE=2><BR><BR><BR>Date: March 2, 2009 </FONT></TD>
<TD WIDTH=10%><FONT FACE="Times New Roman, Times, Serif" SIZE=2></FONT></TD>
<TD WIDTH=50%><FONT FACE="Times New Roman, Times, Serif" SIZE=2><B>PLURISTEM THERAPEUTICS INC.</B><BR><BR>
<BR>By: /s/ Yaky Yanay<BR>&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;&#151;<BR>
Yaky Yanay<BR>Chief Financial Officer</FONT></TD>
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     <!-- Control Number: 96468                                                            -->
     <!-- Rev Number:     1                                                                -->
     <!-- Client Name:    Pluristem Therapeutics Inc                                       -->
     <!-- Project Name:   8-K                                                              -->
     <!-- Firm Name:      Zadok-Keinan Ltd                                                 -->
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<P align=right><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><U><B>Exhibit 99.1</B></U> </FONT> </P>

<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE=2>
<IMG SRC="pluristem.jpg"></FONT></P>

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<P ALIGN=center><FONT FACE="Times New Roman, Times, Serif" SIZE="3"><B>Pluristem
Therapeutics Receives FDA Clearance to Begin &#147;First-In-<BR>Human&#148; Placenta-Derived
Stem Cell Clinical Trial</B> </FONT></P>

<P align=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><B><I>Clearance of IND Filing Paves Way for US-based Trial That Will Enroll Patients with
<BR>Critical Limb Ischemia Who Are Facing Amputation</I></B> </FONT> </P>


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<P ALIGN=center><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><B>Company
to Hold Conference Call at 10:30 am Eastern Time to Discuss Development</B> </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2><B>NEW YORK &#150; (BUSINESS WIRE)
&#150; </B><U>Pluristem Therapeutics Inc.</U> (NasdaqCM: PSTI; DAX: PJT), a
bio-therapeutics company dedicated to the commercialization of unrelated donor-patient
(<U>allogeneic</U>) cell therapy products for a variety of disorders, announced today that
the US Food &amp; Drug Administration (FDA) has cleared the Company&#146;s Investigational
New Drug (IND) application to initiate a Phase I clinical trial for the treatment of
Critical Limb Ischemia (CLI), the end stage of peripheral artery disease (PAD), using
Pluristem&#146;s PLX-PAD. This will be the world&#146;s first clinical trial using
PLX-PAD, Pluristem&#146;s placenta-derived stem cells that are expanded using the
Company&#146;s proprietary 3D PluriX&#153; technology. PLX-PAD is an off-the-shelf,
one-size-fits-all product that needs no tissue matching prior to being administered to
patients. In this Phase I dose ranging trial, to be conducted at multiple locations in the
US, PLX-PAD will be administered to patients considered &#147;late stage&#148; and defined
as patients afflicted with CLI that have not responded to traditional medical or surgical
interventions. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Zami Aberman, Chairman, President and
CEO of Pluristem stated: &#147;We are excited the FDA has cleared our IND application for
our PLX-PAD product so quickly. PLX-PAD is our first product candidate in our PLX pipeline
and this clinical trial will be the first time a placenta-derived stem cell product, grown
using our 3D expansion technology, will be used in humans. Our PLX cells are an
off-the-shelf, one-size-fits-all product that needs no tissue matching prior to being
administered to patients. We believe this unique approach can provide patients with an
affordable, immediate source of cell therapy and will position Pluristem as a leader in
the cell therapy field.&#148; </FONT></P>


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<P><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><B>Conference Call:</B> <BR>The Company will hold a conference
call at 10:30 am Eastern time today to discuss this development. To access the call,
interested parties should dial 877-852-6581 (domestically) or 719-325-4745
(internationally) and use passcode 8547397. Interested parties in Israel should dial
180-944-8286 and use passcode 236197063 (the Q&amp;A session will not be open on the
Israeli dial in number). There will also be a replay of the call available for 10 days. To
access the replay, interested parties should dial 888-203-1112 (domestically) or
719-457-0820 (internationally) and use passcode 8547397. The call will also be webcast and
can be accessed at <U>www.pluristem.com</U>. </FONT> </P>

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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>About Critical Limb
Ischemia </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>In the US alone, it is estimated that
8-12 million people suffer from critical limb ischemia associated with peripheral artery
diseases (PAD). The disease is characterized by narrowing and hardening of the arteries in
the patient&#146;s limb(s) caused and/or aggravated by diabetes, Buerger&#146;s Disease,
other diseases and smoking. With decreased blood flow to the affected extremity, patients
can suffer a host of complications including nerve and tissue damage. In advanced stages,
critical limb ischemia can lead to gangrene, which often requires treatment with
amputation. The disease is associated with a high rate of mortality and the need for
frequent hospitalization from surgical complications. </FONT></P>

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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>About Pluristem </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Pluristem Therapeutics Inc. is a
bio-therapeutics company dedicated to the commercialization of unrelated donor-patient
(allogeneic) cell therapy products for the treatment of several severe degenerative,
ischemic and autoimmune disorders. The Company is developing a pipeline of products,
stored ready-to-use, that are derived from human <U>placenta</U>, a non-controversial,
non-embryonic, adult stem cell source. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>These placental adherent stromal
cells (ASCs) are expanded in the Company&#146;s proprietary PluriX<SUP>TM</SUP> 3D
bioreactor, which imitates the natural 3D microenvironment of these cells and does not
require supplemental growth factors or other exogenous materials. Pluristem believes that
the resultant PLX (PLacental eXpanded) cells&#146; efficacy may be related to the
secretion of cytokines or other potent immune modulators. Furthermore, PLX cells are
immune privileged and possess immunomodulatory properties, thus protecting the recipient
from immunological reactions that often accompany transplantations. </FONT></P>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Pluristem&#146;s first product in
development, PLX-PAD, is intended to improve the quality of life of millions of people
suffering from peripheral artery disease (PAD). The Company&#146;s products in development
also include PLX-IBD, targeting Inflammatory Bowel Disease (IBD); PLX-MS, targeting
Multiple Sclerosis; PLX-BMT, targeting the global shortfall of matched tissue for bone
marrow transplantation (BMT) by improving the engraftment of hematopoietic stem cells
(HSCs) contained in umbilical cord blood; and PLX-STROKE, targeting ischemic stroke.
<BR><BR>Pluristem has offices in the USA with research and manufacturing facilities in Israel. <BR><BR>See
our product animation on YouTube: <B><U>Animation</U></B><U></U>, the content of which is
not part of this press release. </FONT></P>

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<H1 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Safe Harbor Statement </FONT></H1>

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<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>This press release contains
forward-looking statements within the meaning of the &#147;safe harbor&#148; provisions of
the Private Securities Litigation Reform Act of 1995 and federal securities laws. For
example, when we discuss our clinical trial and say that in this Phase I dose ranging
trial, to be conducted at multiple locations in the US, PLX-PAD will be administered to
patients considered &#147;late stage&#148;, or that this clinical trial will be the first
time a placenta-derived stem cell product, grown using our 3D expansion technology, will
be used in humans, or that we believe that this unique approach can provide patients with
an affordable, immediate source of cell therapy and will position us as a leader in the
cell therapy field, we are using forward-looking statements. These forward-looking
statements are based on the current expectations of the management of Pluristem only, and
are subject to a number of factors and uncertainties that could cause actual results to
differ materially from those described in the forward-looking statements. The following
factors, among others, could cause actual results to differ materially from those
described in the forward-looking statements: changes in technology and market
requirements; our technology may not be validated as we progress further and our methods
may not be accepted by the scientific community; we may be unable to retain or attract key
employees whose knowledge is essential to the development of our products; unforeseen
scientific difficulties may develop with our process; results in the laboratory may not
translate to equally good results in real surgical settings; our patents may not be
sufficient; our products may harm recipients; changes in legislation; inability to timely
develop and introduce new technologies, products and applications; loss of market share
and pressure on pricing resulting from competition, which could cause the actual results
or performance of Pluristem to differ materially from those contemplated in such
forward-looking statements. Except as otherwise required by law, Pluristem undertakes no
obligation to publicly release any revisions to these forward-looking statements to
reflect events or circumstances after the date hereof or to reflect the occurrence of
unanticipated events. For a more detailed description of the risk and uncertainties
affecting Pluristem, reference is made to Pluristem&#146;s reports filed from time to time
with the Securities and Exchange Commission. </FONT></P>

<!-- MARKER FORMAT-SHEET="Para Flush Lv 0-TNR" FSL="Workstation" -->
<P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>For more information visit our
website at <U>www.pluristem.com</U>, the content of which is not part of this press
release. </FONT></P>

<!-- MARKER FORMAT-SHEET="Head Left-TNR" FSL="Default" -->
<P ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><I>Contact:</I> </FONT> </P>

<P><FONT FACE="Times New Roman, Times, Serif" SIZE="2"><I>Pluristem Therapeutics Inc.
<BR>William Prather RPh, MD
<BR>Sr. VP Corporate Development
<BR>+1-303-883-4954
<BR><U>William.PratherMD@pluristem.com</U></I> </FONT> </P>


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