GlucoTrack® Moves Forward with FDA Approval Process
Clinical Trial Initiation Planned for Early 2016
Oct 29, 2015, 11:42 ET
ASHKELON, Israel, Oct. 29, 2015 /PRNewswire/ -- Integrity Applications, Inc. (OTCQB: IGAP), maker of GlucoTrack®, a non-invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes, announced today that on October 19, 2015, it met with the U.S. Food and Drug Administration (FDA), to discuss its clinical trial protocol for GlucoTrack® Model DF-F.
The meeting followed submission in August 2015 of pre-submission documents to the FDA, including the U.S. clinical trial protocol.
Subject to approval of the clinical trial protocol by the FDA, the Company expects to begin clinical trials in the United States in early 2016.
"We continue to be diligent with our FDA approval process efforts," said Avner Gal, Integrity Applications CEO and President. "We plan to work closely with the FDA, our clinical investigators, and our regulatory team to implement the FDA's feedback and execute the study protocol."
About GlucoTrack®
GlucoTrack® is a non-invasive device for measuring glucose levels of people with Type 2 diabetes or at risk of developing diabetes.
The GlucoTrack® Model DF-F is expected to begin clinical trials for United States FDA approval in early 2016, subject to approval of Integrity Applications' clinical trial protocol by the FDA. The device is not available for sale in the United States.
GlucoTrack® Model DF-F 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.
GlucoTrack® Model DF-F is currently under assessment with the China Food and Drug Administration (CFDA) as well as food and drug governing bodies in Japan, South Korea Canada and Australia.
GlucoTrack® 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.
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 more frequent 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); risks relating to obtaining regulatory approval in the United States and in foreign jurisdictions; risks relating to the conduct of clinical trials; 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.