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GlucoTrack® Maker Submitted Pre-Submission Supplement to US FDA

June 1st, 2016

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GlucoTrack® Maker Submitted Pre-­Submission Supplement to US FDA

SHDOD, Israel, June 1, 2016 /PRNewswire/ – Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non­invasive device for measuring glucose levels of people with Type 2 diabetes, announced that it has set a conference call with the United States Food and Drug Administration (FDA), expected to take place in July 2016, for further discussion regarding the Company’s pre-submission supplement (including clinical trial protocol) for its GlucoTrack® Model DF­F device submitted to the FDA for review on May 10, 2016. Such protocol was modified to reflect FDA remarks and discussions with the Company during a Pre-Submission meeting which took place in October 2015. Following the July discussion and subject to FDA approval of the Company’s clinical trial protocol, the Company plans to initiate the pivotal clinical study in the third quarter of 2016.

 

About GlucoTrack®

GlucoTrack® is a non­invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes that does not require pricking of the fingers to draw blood for daily glucose monitoring. GlucoTrack® features a small sensor that clips to the earlobe and measures the wearer’s glucose level by taking measurements using three technologies. The measured signals are analyzed using a proprietary algorithm and displayed on a small handheld device the size of a mobile phone. The derived glucose measurement is also announced verbally, facilitating use by elderly and vision-impaired diabetes patients.

 

The GlucoTrack® Model DF­F is expected to begin clinical trials for United States FDA approval in 2016, subject to approval of Integrity Applications’ clinical trial protocol by the FDA. The product is experimental in the United States and is limited to investigational use.

 

GlucoTrack® Model DF­F obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and recently received approval to market the device also to pre-diabetics.

 

About Integrity Applications, Inc.        

Integrity Applications, Inc. is a medical device company focused on the design, development and commercialization of non-invasive glucose monitoring devices for use by people with diabetes. Integrity Applications has developed the GlucoTrack® model DF­F noninvasive glucose monitoring device, which is designed to help people with diabetes obtain glucose level measurements without the pain, inconvenience, incremental cost and difficulty or discomfort of conventional (invasive) spot finger stick devices. Integrity Applications operates primarily through its wholly-owned Israeli subsidiary, A.D. Integrity Applications, Ltd. For more information, please visit www.integrity-app.com.

 

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements contained in this news release that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “expect”, “plan” and “will” are intended to identify forward-looking statements. Readers are cautioned that certain important factors may affect Integrity Applications’ actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect Integrity Applications’ results include, but are not limited to, the ability of Integrity Applications to raise additional capital to finance its operations (whether through public or private equity offerings, debt financings, strategic collaborations or otherwise); risks relating to the receipt (and timing) of regulatory approvals (including FDA approval); risks relating to enrollment of patients in, and the conduct of, clinical trials; risks relating to its current and future distribution agreements; risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel; and the additional risk factors described in Integrity Applications’ filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2015 as filed with the SEC on March 30, 2016.

 

Contact:          

Eran Hertz, CFO Integrity Applications,

+972 (8) 675-7878 Ext. 400,

eranh@integrity-app.com

 

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