Integrity Applications Receives CE Mark Approval for Multiple Improvements to GlucoTrack® Model DF-F
ASHKELON, Israel, Aug. 31, 2015 /PRNewswire/ -- Integrity Applications, Inc. (OTCQB: IGAP) (the "Company" or "Integrity"), has announced that it has received CE Mark approval from Dekra Certification B.V., its Notified Body in the European Union for improvements to the GlucoTrack model DF-F noninvasive glucose measurement device. As a result of these improvements, the calibration process for the device, which previously required eight finger stick measurements as a reference and took approximately two and half hours to complete, now requires just three finger stick measurements and takes less than thirty minutes to complete.
These improvements are expected to greatly enhance the user experience and allow for doctors and clinicians to calibrate more users, more expeditiously, which is expected to reduce or eliminate any backlog created as new device users await calibration.
In addition, the Notified Body has approved an expansion of the intended use of the GlucoTrack model DF-F to allow for the marketing of the device to the pre-diabetic population as well.
"Shortening the calibration time is a meaningful improvement to the practicality of the device and for its usability," said Prof. Lutz Heinemann, Ph.D, Chairman of Integrity's Scientific Advisory Board. "The updated intended use is extremely significant for the Company; providing those suffering from pre-diabetes a tool to monitor his or her glucose levels is crucial for postponing, or even preventing diabetes from developing."
Avner Gal, President and CEO of Integrity Applications, said, "This is a great day for the Company. Receiving the CE Mark approval for these improvements is extremely exciting for us. We believe that a calibration process requiring only three finger stick measurements, takes less than thirty minutes and still valid for six months is a major breakthrough for non-invasive glucose monitoring. In addition, receiving approval to market our device to pre-diabetics, practically doubles our addressable potential market. We are excited about bringing the device to the market and the opportunity that lies ahead of us."
About GlucoTrack
GlucoTrack features a small sensor that clips to the earlobe and measures the wearer's glucose level by taking measurements using three technologies. The measurements 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, making it suitable for the elderly and vision-impaired diabetes patients. The Company has obtained a CE Mark approval for its GlucoTrack model DF-F in Europe (June 2013) and final CE Mark approval in March 2014, and intends to seek Food and Drug Administration approval for GlucoTrack Model DF-F in the United States.
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" 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); the ability of Integrity Applications to successfully commercialize the GlucoTrack model DF-F; the ability of the GlucoTrack model DF-F to achieve acceptable pricing, adequate third party reimbursement or market acceptance; the ability of Integrity Applications to manage its growth and the expansion of its operations to include commercialization activities; risks relating to the use of third party manufacturers; risks relating to the development of Integrity Applications' sales, marketing and distribution capability, either on its own or through collaborations with marketing partners; the possibility that the distributors will not satisfy their minimum purchase commitments under their distribution agreements; and the additional risk factors described in Integrity Applications' filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2014.
Contact:
Eran Hertz,
CFO Integrity Applications
+972 (8) 675-7878 ext. #3
[email protected]
SOURCE Integrity Applications, Inc.
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