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07.11.2016 15:05
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GlucoTrack® Maker Announces Receipt of Final Regulatory Approval in South Korea
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PR Newswire
ASHDOD, Israel, Nov. 7, 2016
ASHDOD, Israel, Nov. 7, 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 today that it has received the final regulatory approval required to market and sell the GlucoTrack model DF-F in South Korea.
The Company had recently disclosed that it had received initial regulatory approval from the Korean Ministry of Food and Drug Safety (KMFDS, formerly KFDA) for the GlucoTrack® model DF-F; however, prior to commencing sales the Company would be required to undergo a GMP (Good Manufacturing Practice) audit. The audit has been completed and the Company has now received final approval to begin selling the device.
In addition, the Company announced that its South Korean distribution partner placed an immediate initial order for 100 GlucoTrack® model DF-F units upon receipt of the KMFDS' regulatory approval.
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,
eranh@integrity-app.com
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/glucotrack-maker-announces-receipt-of-final-regulatory-approval-in-south-korea-300358300.html
SOURCE Integrity Applications, Inc.
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