ASHDOD, Israel, Nov. 10, 2016 /PRNewswire/ -- Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non-invasive device for measuring glucose levels of people with Type 2 diabetes and pre-diabetics, announced that it is presenting today at the 16th Annual Diabetes Technology Meeting in Bethesda, Maryland.
The Company had recently disclosed that it had engaged with a leading clinic in Germany, Pfutzner Science & Health Institute, GmbH, headed by Prof. Dr. Andreas Pfutzner, to conduct additional clinical trials on subjects with Type 2 diabetes and pre-diabetics. These trials have been completed with favorable results and the Company will present these results, as well as recent results from trial conducted at Soroka University Medical Center, Beer-Sheva, Israel in its presentation. Most notably, the presentation will include data supporting that the GlucoTrack's accuracy has been improved significantly. Results from the trials show 99.7% of the study data points were within the clinically accepted A and B zones of the Consensus Error Grid (type 2), 99.3% of the study data points were within the clinically accepted A and B zones of the Clarke Error Grid, 17.0% Mean Absolute Relative Difference, and 12.9% Median Absolute Relative Difference.
In addition, the German trial concluded that the data confirms the performance of the GlucoTrack® among its intended users, including pre-diabetic patients.
About GlucoTrack®
GlucoTrack® is a non-invasive 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 DF-F is expected to begin clinical trials for United States FDA approval in early 2017. The product is currently experimental in the United States and is limited to investigational use only.
GlucoTrack® Model DF-F obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and in December 2015 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 DF-F non-invasive 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 [email protected]
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The Company had recently disclosed that it had engaged with a leading clinic in Germany, Pfutzner Science & Health Institute, GmbH, headed by Prof. Dr. Andreas Pfutzner, to conduct additional clinical trials on subjects with Type 2 diabetes and pre-diabetics. These trials have been completed with favorable results and the Company will present these results, as well as recent results from trial conducted at Soroka University Medical Center, Beer-Sheva, Israel in its presentation. Most notably, the presentation will include data supporting that the GlucoTrack's accuracy has been improved significantly. Results from the trials show 99.7% of the study data points were within the clinically accepted A and B zones of the Consensus Error Grid (type 2), 99.3% of the study data points were within the clinically accepted A and B zones of the Clarke Error Grid, 17.0% Mean Absolute Relative Difference, and 12.9% Median Absolute Relative Difference.
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In addition, the German trial concluded that the data confirms the performance of the GlucoTrack® among its intended users, including pre-diabetic patients.
About GlucoTrack®
GlucoTrack® is a non-invasive 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 DF-F is expected to begin clinical trials for United States FDA approval in early 2017. The product is currently experimental in the United States and is limited to investigational use only.
GlucoTrack® Model DF-F obtained a CE Mark approval in Europe (June 2013) and final CE Mark approval in March 2014 and in December 2015 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 DF-F non-invasive 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 [email protected]
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SOURCE Integrity Applications, Inc.
