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<SEC-DOCUMENT>0000950123-09-045770.txt : 20090924
<SEC-HEADER>0000950123-09-045770.hdr.sgml : 20090924
<ACCEPTANCE-DATETIME>20090924171022
ACCESSION NUMBER:		0000950123-09-045770
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20090922
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20090924
DATE AS OF CHANGE:		20090924

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Protalix BioTherapeutics, Inc.
		CENTRAL INDEX KEY:			0001006281
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				650643773
		STATE OF INCORPORATION:			FL
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33357
		FILM NUMBER:		091085562

	BUSINESS ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100
		BUSINESS PHONE:		972-4-988-9488

	MAIL ADDRESS:	
		STREET 1:		2 SNUNIT ST
		STREET 2:		SCIENCE PARK, POB 455
		CITY:			CARMIEL
		STATE:			L3
		ZIP:			20100

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ORTHODONTIX INC
		DATE OF NAME CHANGE:	19980422

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	EMBASSY ACQUISITION CORP
		DATE OF NAME CHANGE:	19960124
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<DOCUMENT>
<TYPE>8-K
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<FILENAME>y02301e8vk.htm
<DESCRIPTION>FORM 8-K
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<HTML>
<HEAD>
<TITLE>e8vk</TITLE>
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<BODY bgcolor="#FFFFFF">
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<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 1pt solid black; font-size: 1pt">&nbsp;</DIV>


<DIV align="center" style="font-size: 14pt; margin-top: 12pt"><B>UNITED STATES<BR>
SECURITIES AND EXCHANGE COMMISSION</B>
</DIV>

<DIV align="center" style="font-size: 12pt"><B>Washington, D.C. 20549</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="center" style="font-size: 18pt; margin-top: 12pt"><B>FORM 8-K</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>


<DIV align="center" style="font-size: 12pt; margin-top: 12pt"><B>CURRENT REPORT<BR>
Pursuant to Section&nbsp;13 or 15(d) of<BR>
the Securities Exchange Act of 1934</B>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Date of Report (Date of Earliest Event Reported): September&nbsp;22, 2009</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="center" style="font-size: 24pt; margin-top: 12pt"><B>Protalix BioTherapeutics, Inc.</B>
</DIV>

<DIV align="center" style="font-size: 10pt"><B>(Exact name of registrant as specified in its charter)</B></DIV>


<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="30%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>Florida</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>000-33357</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>65-0643773</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(State or other jurisdiction</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Commission File Number)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(IRS Employer</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>of incorporation)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>Identification No.)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="47%">&nbsp;</TD>
    <TD width="5%">&nbsp;</TD>
    <TD width="47%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD align="center" valign="top"><B>2 Snunit Street</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>20100</B></TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>Science Park, POB 455</B></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>Carmiel, Israel</B></TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD align="center" valign="top"><B>(Address of principal executive offices)</B>
</TD>
    <TD>&nbsp;</TD>
    <TD align="center" valign="top"><B>(Zip Code)</B></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>Registrant&#146;s telephone number, including area code &#043;972-4-988-9488</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><B>(Former name or former address, if changed since last report.)</B></DIV>

<DIV align="center" style="font-size: 10pt; margin-top: 12pt"><DIV align="center"><DIV style="font-size: 3pt; margin-top: 16pt; width: 26%; border-top: 1px solid #000000">&nbsp;</DIV></DIV></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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):
</DIV>


<DIV style="margin-top: 6pt">
<TABLE width="100%" border="0" cellpadding="0" cellspacing="0" style="font-size: 10pt">

<TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Written communications pursuant to Rule&nbsp;425 under the Securities Act (17 CFR 230.425)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Soliciting material pursuant to Rule&nbsp;14a-12 under the Exchange Act (17 CFR 240.14a-12)</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))</TD>
</TR>

<TR>
    <TD style="font-size: 6pt">&nbsp;</TD>
</TR><TR valign="top" style="font-size: 10pt; color: #000000; background: transparent">
    <TD width="1%" nowrap align="left"><FONT face="Wingdings">&#111;</FONT></TD>
    <TD width="1%">&nbsp;</TD>
    <TD>Pre-commencement communications pursuant to Rule&nbsp;13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c))</TD>
</TR>

</TABLE>
</DIV>

<DIV style="width: 100%; border-bottom: 1pt solid black; margin-top: 12pt; font-size: 1pt">&nbsp;</DIV>
<DIV style="width: 100%; border-bottom: 2pt solid black; font-size: 1pt">&nbsp;</DIV>



<P align="center" style="font-size: 10pt"><!-- Folio -->&nbsp;<!-- /Folio -->
</DIV>

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<H5 align="left" style="page-break-before:always">&nbsp;</H5><P>


<DIV style="font-family: 'Times New Roman',Times,serif">

<!--TOC-->
<A name="toc"><DIV align="CENTER"><U><B>TABLE OF CONTENTS</B></U></DIV></A>

<P><CENTER>
<TABLE border="0" width="90%" cellpadding="0" cellspacing="0">
<TR>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="3%"></TD>
        <TD width="76%"></TD>
</TR>
<TR><TD colspan="9"><A HREF="#000">Item&nbsp;8.01. Other Events</A></TD></TR>
<TR><TD colspan="9"><A HREF="#001">Item&nbsp;9.01. Financial Statements and Exhibits</A></TD></TR>
<TR><TD colspan="9"><A HREF="#002"> SIGNATURES</A></TD></TR>
<TR><TD colspan="9"><A HREF="y02301exv99w1.htm">EX-99.1</A></TD></TR>
</TABLE>
</CENTER>
<!--/TOC-->






<!-- link1 "Item&nbsp;8.01. Other Events" -->
<DIV align="left"><A NAME="000"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;8.01. Other Events</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">On September&nbsp;22, 2009, Protalix BioTherapeutics, Inc. (the &#147;Company&#148;) issued a press release
reporting preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel&#153;). A
copy of the press release is attached hereto as Exhibit&nbsp;99.1.
</DIV>

<!-- link1 "Item&nbsp;9.01. Financial Statements and Exhibits" -->
<DIV align="left"><A NAME="001"></A></DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Item&nbsp;9.01. Financial Statements and Exhibits</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>(d)&nbsp;Exhibits</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">99.1 Press release dated September&nbsp;22, 2009.
</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->2<!-- /Folio -->
</DIV>

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<DIV style="font-family: 'Times New Roman',Times,serif">



<!-- link1 " SIGNATURES" -->

<DIV align="center" style="font-size: 10pt; margin-top: 18pt"><B>SIGNATURES</B>
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">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.
</DIV>
<DIV align="center">
<TABLE style="font-size: 10pt" cellspacing="0" border="0" cellpadding="0" width="100%">
<!-- Begin Table Head -->
<TR valign="bottom">
    <TD width="40%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="3%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="35%">&nbsp;</TD>
    <TD width="1%">&nbsp;</TD>
    <TD width="15%">&nbsp;</TD>
</TR>
<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom">
    <TD valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD colspan="3" valign="top" align="left"><B>PROTALIX BIOTHERAPEUTICS, INC.</B></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom"><!-- Blank Space -->
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">Date: September&nbsp;24, 2009
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">By:<BR>
Name:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">/s/ David Aviezer
<DIV style="font-size: 1pt; border-top: 1px solid #000000">&nbsp;</DIV>
David Aviezer, Ph.D.
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Title:
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">President and</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
<TR valign="bottom">
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;
</DIV></TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">Chief Executive Officer</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top">&nbsp;</TD>
</TR>
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</DIV>


<P align="center" style="font-size: 10pt"><!-- Folio -->3<!-- /Folio -->
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<DIV style="font-family: 'Times New Roman',Times,serif">


<DIV align="right" style="font-size: 10pt; margin-top: 12pt">Exhibit&nbsp;99.1
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt"><B>Protalix Reports Preclinical Data on Anti-TNF Follow-on Biologic Arthritis Drug</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">CARMIEL, Israel, September&nbsp;22, 2009 (Business Wire) &#151; Protalix Biotherapeutics, Inc. (NYSE-Amex:
PLX), reported today preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel&#153;).
Produced using the Company&#146;s proprietary ProCellEx&#153; technology, pr-antiTNF is a plant cell
expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR),
fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid
sequence to Enbrel&#153;.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity
to Enbrel&#153;. Specifically, pr-antiTNF binds TNF alpha thereby inhibiting it from binding to cellular
surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent
manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF
administered intraperitoneally significantly improved the clinical arthritis parameters associated
with this accepted arthritis mouse model including joint inflammation, swelling and tissue
degradation. Data from the collagen induced arthritis animal model studies are expected to be
presented at an upcoming scientific conference.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">&#147;We are very encouraged by the preclinical data generated from our pr-antiTNF thus far,&#148; said Dr.
Yoseph Shaaltiel, Executive Vice President, R&#038;D of Protalix. &#147;These data further validate our
ProCellEx&#153; technology and its ability to produce a wide range of complex therapeutic proteins in
plant cells. Given our highly efficient and cost effective manufacturing process, we feel the
Company is well positioned to be an active participant in the biosimilar market.&#148;
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>About Protalix BioTherapeutics</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Protalix is a biopharmaceutical company. Its goal is to become a fully integrated biopharmaceutical
company focused on the development and commercialization of proprietary recombinant therapeutic
proteins to be expressed through its proprietary plant cell based expression system. Protalix&#146;s
ProCellEx(TM) presents a proprietary method for the expression of recombinant proteins that
Protalix believes will allow for the cost-effective, industrial-scale production of recombinant
therapeutic proteins in an environment free of mammalian components and viruses. Protalix completed
a Phase III pivotal study for its lead product candidate, UPLYSO (prGCD), to be used in enzyme
replacement therapy for Gaucher disease, a rare and serious lysosomal storage disorder in humans
with severe and debilitating symptoms. Protalix and the U.S. Food and Drug Administration agreed on
the final design of the pivotal Phase III clinical trial through the FDA&#146;s Special Protocol
Assessment (SPA)&nbsp;process. Protalix is also advancing additional recombinant biopharmaceutical drug development programs.
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt"><B>Safe Harbor Statement:</B>
</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 6pt">To the extent that statements in this press release are not strictly historical, all such
statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private
</DIV>



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<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Securities Litigation Reform Act of 1995. These forward-looking statements are subject to known and
unknown risks and uncertainties that may cause actual future experience and results to differ
materially from the statements made. These statements are based on our current beliefs and
expectations as to such future outcomes. Drug discovery and development involve a high degree of
risk. Factors that might cause material differences include, among others, risks relating to: the
successful preclinical development of our product candidates; the completion of clinical trials;
the review process of the FDA, foreign regulatory bodies and other governmental regulation,
including the FDA&#146;s review of any filings we make in connection with the treatment protocol; delays
in the FDA&#146;s or other health regulatory authorities&#146; approval of any applications we file or
refusals to approve such filings; refusals by such regulatory authorities to approve the marketing
and sale of a drug product even after acceptance of an application we file for any such drug
product; the identification of lead compounds; the risk that we may fail to satisfy certain
conditions relating to grants we have received from the Office of the Chief Scientist of Israel&#146;s
Ministry of Industry and Trade which may lead to our being required to refund grants previously
received together with interest and penalties; the risk that the Office of the Chief Scientist may
not deliver to us all of the funds awarded to us; uncertainties related to the ability to attract
and retain partners for our technologies and products under development; and other factors
described in our filings with the Securities and Exchange Commission. Under the approved treatment
protocol, UPLYSO (prGCD) might be provided only to a limited number of patients and only for a
limited time. Pharmaceutical and biotechnology companies have suffered significant setbacks in
advanced clinical trials, even after promising results in earlier clinical trials or in preliminary
findings for such clinical trials. The FDA&#146;s approval of the treatment protocol for UPLYSO (prGCD)
or the fast track approval will not have any effect on the FDA&#146;s approval of any NDA we file with
respect to UPLYSO (prGCD), if any, and the review by the FDA of any data from the Phase III
clinical development programs in connection with the approval of the treatment protocol will not
have any effect on the FDA&#146;s subsequent review of our complete Phase III clinical trial data in the
future. The statements are valid only as of the date hereof and we disclaim any obligation to
update this information.
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 12pt">Contact:
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Marcy Nanus<BR>
The Trout Group, LLC<BR>
Telephone: 646-378-2927<BR>
Email: <u>mnanus@troutgroup.com</u>

</DIV>

<DIV align="left" style="font-size: 10pt; margin-top: 12pt">Media Contact:
</DIV>


<DIV align="left" style="font-size: 10pt; margin-top: 6pt">Brad Miles<BR>
BMC Communications Group, LLC<BR>
Telephone: 212-477-9007 x17<BR>
Email: <u>brad@bmccommunications.com</u>

</DIV>


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