News & Press Releases
Integrity Applications Receives CE Mark Approval for Self-Calibration Version of its GlucoTrack® Non-Invasive Glucose Monitoring Device
January 21st, 2020
Major Milestone Simplifies Use and Opens Up Additional Sales and Distribution Channels
Wilmington, DE and Ashdod, Israel, Jan. 21, 2020 (GLOBE NEWSWIRE) — Integrity Applications, Inc. (www.integrity-app.com) (OTCQB: IGAP), innovator of GlucoTrack®, a non-invasive device for measuring glucose levels in people with Type 2 diabetes and prediabetes, announced today that it has received CE Mark approval for a major enhancement to GlucoTrack, allowing for a user to perform the calibration process by themselves, without the need for a certified calibrator.
The initial CE Mark approval received for GlucoTrack required a calibration process that took three hours to complete, required eight invasive finger stick reference measurements, needed to be repeated every thirty days and required a certified calibrator to perform the calibration.
After a series of successful enhancements and approvals, the calibration process now takes just thirty minutes, requires just three invasive reference measurements, and needs to be repeated only once every six months. With self-calibration, a user can now perform this simplified process in the privacy and convenience of their own home.
“This is a major milestone and its importance cannot be overstated”, said David Malka, President of Integrity Applications. “With the ability for a user to self-calibrate and not be dependent on the availability of a certified calibrator, the Company now has a pathway to commercialize GlucoTrack on a mass scale through its distribution partners, and in certain markets, directly to the consumer.” Mr. Malka further stated, “this enhancement is a direct result of the Company’s aggressive R&D program and product roadmap, which it will continue as it develops and delivers innovative solutions for those living with Type 2 diabetes and prediabetes.”
GlucoTrack® is a truly non-invasive monitoring device that rapidly measures and displays an individual’s glucose level in about a minute without finger pricking or any pain. GlucoTrack® features an ear clip with sensors that clips to the earlobe and measures the user’s glucose level using innovative and patented sensor technologies. The measured signals are analyzed using a proprietary algorithm and then a calculated glucose level is displayed on a small handheld device the size of a small mobile phone. The glucose results are stored in the device and used to estimate HbA1c level using a proprietary algorithm. The device can also display glucose values graphically, enabling the user to monitor glucose levels over time. GlucoTrack® has received approvals for CE Mark in Europe and from the Ministry of Food and Drug Safety in South Korea for type 2 diabetes and prediabetes and is currently available in selected markets in Europe and Asia.
About Integrity Applications, Inc.
Integrity Applications, Inc. (OTCQB: IGAP) was founded in 2001 and is focused on the design, development, and commercialization of non-invasive glucose monitoring technologies for people with type 2 diabetes and prediabetes. The Company has developed GlucoTrack®, a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements in about a minute without the pain, incremental cost, difficulty, or discomfort of conventional invasive finger stick devices. Integrity Applications Inc. is a Delaware corporation, with headquarters in the United States and an R&D site in Ashdod, Israel. For more information, please visit http://www.integrity-app.com/ and http://www.glucotrack.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”, “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 (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on April 12, 2019.Back to all news & press releases