<SEC-DOCUMENT>0001079973-14-000069.txt : 20140124
<SEC-HEADER>0001079973-14-000069.hdr.sgml : 20140124
<ACCEPTANCE-DATETIME>20140124061905
ACCESSION NUMBER:		0001079973-14-000069
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20140124
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20140124
DATE AS OF CHANGE:		20140124

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Venaxis, Inc.
		CENTRAL INDEX KEY:			0001167419
		STANDARD INDUSTRIAL CLASSIFICATION:	IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835]
		IRS NUMBER:				841553387
		STATE OF INCORPORATION:			CO
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-33675
		FILM NUMBER:		14544451

	BUSINESS ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104
		BUSINESS PHONE:		(303) 794-2000

	MAIL ADDRESS:	
		STREET 1:		1585 S. PERRY STREET
		CITY:			CASTLE ROCK
		STATE:			CO
		ZIP:			80104

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	AspenBio Pharma, Inc.
		DATE OF NAME CHANGE:	20051110

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ASPENBIO INC
		DATE OF NAME CHANGE:	20020213
</SEC-HEADER>
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<TYPE>8-K
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<div style="TEXT-INDENT: 36pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On January 24, 2014, Venaxis, Inc. (the &#8220;Company&#8221;) issued a press release titled &#8212; &#8220;Venaxis Completes Patient Enrollment in Pivotal Clinical Trial of APPY1&#8482; Test.&#8221;&#160;&#160;The press release is filed as Exhibit 99.1 to this Form 8-K.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">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, thereunto duly authorized.</font></div>

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<font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Exhibit 99.1</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="center"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 12pt; FONT-WEIGHT: bold">Venaxis Completes Patient Enrollment in Pivotal Clinical Trial of <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1&#8482; Test</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold">CASTLE ROCK, Colo., January 24, 2014</font> &#8212; <font style="DISPLAY: inline; FONT-WEIGHT: bold">Venaxis, Inc.</font> (Nasdaq: <font style="DISPLAY: inline; TEXT-DECORATION: underline">APPY</font>), an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company focused on obtaining FDA clearance and commercializing its CE Marked <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1Test, a rapid, multiple biomarker-based assay for identifying patients that are at low risk for appendicitis, today announced completion of patient enrollment in its pivotal clinical study of the <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 Test in the United States.&#160;&#160;Venaxis expects to announce top-line data following the required patient follow-up period and subsequent database lock and required analysis of the data. The study enrolled patients at approximately 27 hospital sites across the United States, and the pivotal data will be based on approximately 2,000 net evaluable patients.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Steve Lundy, President and Chief Executive Officer of Venaxis&#8482;, commented, &#8220;Completing this significant pivotal U.S. study is a major milestone for Venaxis and we look forward to reporting the data when it is available.&#160;&#160;We will work to finalize our 501(k) and final data package for FDA submission at or near the end of the first quarter, assuming positive data.&#160;&#160;In the meantime, we remain committed to our diligent market development efforts and expect to be well positioned to launch the <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 Test in the United States upon receipt of clearance.&#8221;</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">About Venaxis, Inc.</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Venaxis, Inc. is an <font style="FONT-STYLE: italic; DISPLAY: inline">in vitro</font> diagnostic company focused on the clinical development and commercialization of its CE Marked <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 Test, the Company&#8217;s rapid, protein biomarker-based assay for appendicitis.&#160; This unique appendicitis test has projected high sensitivity and negative predictive value and is being developed to aid in the identification of patients at low risk for acute appendicitis, allowing for more conservative patient management.&#160; The <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 Test is being developed initially for pediatric, adolescent and young adult patients with abdominal pain, as this population is at the highest risk for appendicitis and has the highest risk of long-term health effects associated with CT imaging.&#160; While FDA clearance is being sought, an initial launch for the <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 Test is ongoing in select European countries.&#160;&#160;For more information, visit <font style="DISPLAY: inline; TEXT-DECORATION: underline">www.venaxis.com</font>.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Forward-Looking Statements</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">This press release includes "forward-looking statements" of Venaxis, Inc. (&#8220;Venaxis&#8221;) as defined by the Securities and Exchange Commission ("SEC"). All statements, other than statements of historical fact, included in this press release that address activities, events or developments that Venaxis believes or anticipates will or may occur in the future are forward-looking statements. These statements are based on certain assumptions made based on experience, expected future developments and other factors Venaxis believes are appropriate in the circumstances. Such statements are subject to a number of assumptions, risks and uncertainties, many of which are beyond the control of Venaxis. Investors are cautioned that any such statements are not guarantees of future performance. Actual results or developments may differ materially from those projected in the forward-looking statements as a result of many factors, including our ability to successfully complete required product development and modifications in a timely and cost effective manner, complete clinical trial activities for the <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1<font style="FONT-STYLE: italic; DISPLAY: inline">&#160;</font>Test required for FDA submission, obtain FDA clearance or approval, maintain CE Marking, cost effectively manufacture and generate revenues from the <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1<font style="FONT-STYLE: italic; DISPLAY: inline">&#160;</font>Test at a profitable price point, execute agreements required to successfully advance the company's objectives, retain the management team to advance the products, overcome adverse changes in market conditions and the regulatory environment, obtain and enforce intellectual property rights, and realize value of intangible assets. Furthermore, Venaxis does not intend (and is not obligated) to update publicly any forward-looking statements. The contents of this press release should be considered in conjunction with the risk factors contained in Venaxis&#8217; recent filings with the SEC, including its Form 10-Q for the quarter ended June 30, 2013.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Venaxis and <font style="FONT-STYLE: italic; DISPLAY: inline">APPY</font>1 are trademarks of Venaxis, Inc.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">For Investors and Media:</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; TEXT-DECORATION: underline">Tiberend Strategic Advisors, Inc.</font></font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Joshua Drumm, PhD</font></div>

<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; TEXT-DECORATION: underline">jdrumm@tiberend.com</font>; (212) 375-2664</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="left"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Claire Sojda</font></div>

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