<SEC-DOCUMENT>0001178913-12-003477.txt : 20121219
<SEC-HEADER>0001178913-12-003477.hdr.sgml : 20121219
<ACCEPTANCE-DATETIME>20121219144717
ACCESSION NUMBER:		0001178913-12-003477
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20121219
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20121219
DATE AS OF CHANGE:		20121219

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			Integrity Applications, Inc.
		CENTRAL INDEX KEY:			0001506983
		STANDARD INDUSTRIAL CLASSIFICATION:	SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841]
		IRS NUMBER:				980668934
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-54785
		FILM NUMBER:		121274048

	BUSINESS ADDRESS:	
		STREET 1:		102 HA'AVODA STREET
		STREET 2:		P.O.BOX 432
		CITY:			ASHKELON
		STATE:			L3
		ZIP:			78100
		BUSINESS PHONE:		972 (8) 675-7878

	MAIL ADDRESS:	
		STREET 1:		102 HA'AVODA STREET
		STREET 2:		P.O.BOX 432
		CITY:			ASHKELON
		STATE:			L3
		ZIP:			78100
</SEC-HEADER>
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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: 10pt; FONT-WEIGHT: bold">CURRENT REPORT</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Date of Report (Date of earliest event reported):&#160;&#160;<font style="DISPLAY: inline; TEXT-DECORATION: underline">December 16, 2012</font><font id="TAB2" style="LETTER-SPACING: 3pt; COLOR: black">&#160;</font></font></div>

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<td width="33%" style="BORDER-BOTTOM: black 2px solid; TEXT-ALIGN: center"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline">Delaware</font></font></td>
<td width="33%" style="BORDER-BOTTOM: black 2px solid; TEXT-ALIGN: center"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">0-54785&#160;&#160;&#160;</font></td>
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<td width="33%" style="TEXT-ALIGN: center"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">(State or other jurisdiction&#160;<font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">of incorporation)</font></font></td>
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<td width="67%" style="BORDER-BOTTOM: black 2px solid; TEXT-ALIGN: center"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">102 Ha&#8217;Avoda Street, P.O. Box 432, Ashkelon, Israel&#160;&#160;&#160;</font></td>
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<td width="67%" style="TEXT-ALIGN: center"><font style="FONT-FAMILY: times new roman; FONT-SIZE: 10pt">(Address of principal executive offices)&#160;&#160;</font></td>
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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">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):</font></div>

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<div style="TEXT-INDENT: 0pt; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">Item 8.01</font></div>
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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">On December 16, 2012, Integrity Applications, Inc. (the &#8220;<font style="DISPLAY: inline; TEXT-DECORATION: underline">Company</font>&#8221;) submitted its CE Mark Technical File to its European notified body, DEKRA Certification B.V. (the &#8220;<font style="DISPLAY: inline; TEXT-DECORATION: underline">Notified Body</font>), in connection with its application to obtain CE Mark approval for its GlucoTrack&#174; DF-F model non-invasive glucose monitoring device.&#160;&#160;The Company will be required to submit additional information to the Notified Body in connection with its CE Mark application, including clinical evaluation data.&#160;&#160;If (i) the Company completes the submission of the clinical evaluation data and any other information requested by the Notified Body, (ii) the Notified Body accepts the Company&#8217;s Technical File as satisfactory and (iii) the audits of the Company&#8217;s facilities, quality system and manufacturing process are completed to the satisfaction of the Notified Body, the Company would expect to receive CE Mark approval for the GlucoTrack DF-F glucose monitoring device and an ISO 13485:2003 quality system certificate as early as the end of the first quarter of 2013 under the present timeline.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">The CE Mark is an indication that a medical device complies with the essential requirements of the Medical Devices Directive (93/42/EEC and 2007/47/EC) (the &#8220;<font style="DISPLAY: inline; TEXT-DECORATION: underline">MDD</font>&#8221;) and that the device has been subjected to conformity assessment procedures.&#160;&#160;Receipt of the CE Mark will allow the Company to market and sell the GlucoTrack DF-F glucose monitoring device in EU member countries that have adopted the MDD without being subject to additional national regulations with regard to demonstration of performance and safety (although certain EU member countries may request or require additional performance and/or safety data from time to time, on a case-by case basis).&#160;&#160;The CE mark also permits the sale in countries that have an MDD Mutual Recognition Agreement (&#8220;<font style="DISPLAY: inline; TEXT-DECORATION: underline">MRA</font>&#8221;) with the EU.&#160;&#160;There can be no assurance that the Company will receive CE Mark approval for the GlucoTrack DF-F glucose monitoring device in a timely manner or at all due to, among other things, (i) the Notified Body&#8217;s determination that the Company failed to submit the required clinical evaluation data and other information requested by the Notified Body in a timely manner or at all, (ii) the Notified Body&#8217;s rejection of the Company&#8217;s Technical File, (iii) negative results from the audits of the Company&#8217;s facilities, quality system and/or manufacturing process and (iv) the other risk factors described under the caption &#8220;Risk Factors&#8221; in the Company&#8217;s filings with the Securities and Exchange Commission, including its Annual Report for the fiscal year ended December 31, 2011 and its Quarterly Reports for the quarters ended March 31, 2012, June 30, 2012 and September 30, 2012.</font></div>

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<div style="TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt" align="justify"><font style="DISPLAY: inline; FONT-FAMILY: Times New Roman; FONT-SIZE: 10pt">Date:&#160;&#160;December 19, 2012</font></div>

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<div style="TEXT-ALIGN: left; TEXT-INDENT: 0pt; DISPLAY: block; MARGIN-LEFT: 0pt; MARGIN-RIGHT: 0pt"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt"><font style="DISPLAY: inline; FONT-WEIGHT: bold"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt; FONT-WEIGHT: bold">INTEGRITY APPLICATIONS, INC.</font></font></font></div>
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<td align="left" nowrap valign="top" width="35%" style="BORDER-BOTTOM: black 2px solid"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">/s/&#160;Avner Gal</font></td>
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<td align="left" nowrap valign="bottom" width="35%"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Name: Avner Gal</font></td>
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<td valign="top" width="35%"><font style="DISPLAY: inline; FONT-FAMILY: times new roman; FONT-SIZE: 10pt">Title:&#160;&#160; Chief Executive Officer</font></td>
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