- GlucoTrack® Link wireless module receives CE approval, further enhancing the GlucoTrack® solution.
- GlucoTrack® receives certification to the IEC 60601-1-2 standard in compliance with the January 2019 mandate.
- GlucoTrack® CE Marking gains renewal based on the ISO 13485 and MDD Annex II standards for product and service quality.
Wilmington, DE and Ashdod, Israel, Dec. 07, 2018 (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 pre-diabetes, announced today that the Company has achieved several product development milestones to further support its path to commercialization.
The Company’s new wireless module, GlucoTrack® Link, is now fully approved and lab certified. This is an important enhancement of the capabilities of the GlucoTrack® system and an important step in offering a fully integrated solution for effective diabetes management for people with type 2 diabetes and pre-diabetes.
The GlucoTrack® system has passed all tests and is in compliance with the fourth edition of IEC 60601-1-2 standard. This updated international standard defines the basic and essential performance for medical equipment and replaces the existing IEC standard at the end of 2018, after which time, medical devices that do not comply with this new standard cannot be sold in Europe or the United States.
In addition, the Company has successfully passed the renewal audit for CE Marking (assess conformity to ISO 13485:2016 and Medical Device Directives) for the GlucoTrack® system, including Annex ll capabilities ensuring a full quality assurance system. ISO 13485 is an internationally recognized and harmonized QMS standard, developed especially for medical device companies in order to provide guidance and tools to create an effective quality management system to ensure product and service performance.
“Achievement of these milestones is essential to accelerating GlucoTrack® commercialization in Europe, providing care providers and consumers with a reliable, seamless solution. GlucoTrack® is a unique non-invasive glucose monitoring solution that eliminates painful finger pricks allowing patients to test themselves easily and more frequently as part of an integrated diabetes management approach”, commented David Podwalski, President and Chief Operating Officer.
About GlucoTrack®
GlucoTrack® is a completely 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 a small sensor 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 pre-diabetics 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.
Investor and Media Contact
Sami Sassoun, CFO Integrity Applications
SamiS@integrity-app.com
+972 (8) 675-7878 Ext. 400
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 (the “SEC”), including its Annual Report on Form 10-K for the year ended December 31, 2017 as filed with the SEC on March 31, 2018.