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Integrity Applications Submits protocol to FDA (August 13 2015)
August 13th, 2015Download
Integrity Applications Submits Pre-Submission Documents for the GlucoTrack Model DF-F to U.S. FDA
ASHKELON, Israel, August 13, 2015 /PRNewswire/ — Integrity Applications, Inc. (OTCQB: IGAP) (the “Company” or “Integrity”), developer of the GlucoTrack® model DF-F noninvasive glucose measurement device, has announced that on August 10th, 2015 it submitted pre-submission documents to the U.S. Food and Drug Administration (the “FDA”) in connection with its proposed future application for FDA approval of its U.S. clinical trial protocol.
The pre-submission documentation has been submitted to the FDA in order to obtain the Agency’s guidance regarding the U.S. regulatory pathway for the GlucoTrack® model DF-F, the proper approach to refining the trial protocol and endpoints, and preparing the pre-marketing application. The FDA’s Pre-Submission Program is intended to allow applicants the opportunity to obtain targeted FDA feedback in response to specific questions related to product development, including planned non-clinical evaluations, proposed clinical study protocols, or data requirements, prior to making a submission to the Agency. For more information on the Pre-Submission Program, visit the FDA website at http://www.fda.gov.
If the clinical trial protocol is approved by the FDA, the Company expects to begin clinical trials in the United States in early 2016. Although a final agreement has not been reached, the Company is currently in advanced discussions with a well-known hospital and university to conduct such clinical trials. The GlucoTrack model DF-F is an investigational device in the United States and accordingly it is not available for sale in the United States.
Avner Gal, President and CEO of Integrity Applications, said, “This is an exciting time for the Company as we take the necessary steps to seek to bring the advantages of the GlucoTrack model DF-F non-invasive glucose monitor to the US market”.
The international law firm of Hogan Lovells is advising the Company with the regulatory and clinical pathway in connection with its seeking FDA approval.
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.
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 “propose” 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.
CFO Integrity Applications
+972 (8) 675-7878 ext. #3
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