WILMINGTON, Del. and ASHDOD, Israel, Sept. 14, 2020), a non-invasive device for measuring glucose levels in people with Type 2 diabetes and prediabetes, today provided an update as to its commercialization activities.
Earlier this year, the Company announced that it had received CE Mark approval to simplify the use of GlucoTrack by allowing a user to perform the calibration process by themselves without the need for an on-site trainer for guidance. With this major enhancement, the Company believes it has a pathway to commercialize GlucoTrack on a mass scale through its distribution partners, and in certain markets, directly to the consumer.
Since receiving this approval, the Company has been conducting testing and internal trials of upgraded software and has been developing a redesigned personal ear clip to enhance usability and comfort of the device, all of which have been completed.
The Company has now begun the implementation of its commercial launch with the completion of its initial shipment of redesigned GlucoTrack personal ear clip units and software upgrade to MediReva, its exclusive distribution partner in the Netherlands.
Prior to going into full production, MediReva will conduct field testing on the new units with the self-calibration feature embedded, with the expectation for GlucoTrack to be available to the public early next year. The Company is currently working with several insurance companies on steps towards reimbursement approval.
As part of its planned rollout, in addition to the Netherlands, the Company is in the process of identifying and negotiating with additional distributors in other key geographic regions.
"Low compliance to glucose self-monitoring among patients with Type 2 diabetes and prediabetes is still highly prevalent," said Erez Ben-Zvi, Integrity's Vice President of Product. "Launching our first non-invasive GlucoTrack units with the self-calibration software is key for increased monitoring compliance and a major milestone for the Company. We look forward to a successful launch in the Netherlands and continued execution on our commercial strategy."
"The market desperately needs the solution that GlucoTrack provides. We continue to make progress in our efforts to receive insurance reimbursement for GlucoTrack in the Dutch market, and we are excited to be the first to offer such an innovative product for those suffering with Type 2 diabetes and prediabetes," said Paul Ummels, CEO of MediReva.
About GlucoTrack
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. and http://www.glucotrack.com.
Investor Contact:investors@integrity-app.com
Media Contact: media@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", "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, 2019 as filed with the SEC on April 14, 2020.
