Integrity Applications Issues Shareholder Update Letter
Integrity Applications, Inc. (IGAP) provided an operational update for 2020, emphasizing its response to the COVID-19 pandemic and need for digital health solutions for diabetes. The company expanded its management team, reducing debt and completing a $15 million capital raise. A new development plan for the next-generation GlucoTrack (GT 2.0) aims to enhance accuracy and reduce costs. The company is pursuing U.S. market entry and potential FDA trials while progressing with insurance reimbursement in the Netherlands. Integrity Applications remains optimistic about future growth and market opportunities.
- Completed a $15 million capital raise in 2020.
- Strengthened leadership with experienced hires, including a new CTO and VP of Product.
- Accelerated development of the next-generation GlucoTrack (GT 2.0) for enhanced features and cost-efficiency.
- Progressing towards U.S. market entry and FDA trials.
- Working on insurance reimbursement in the Netherlands.
- Existing debt from prior management may pose financial risks.
- Dependence on successful regulatory approvals and clinical trials to enter the U.S. market.
Wilmington, DE and Ashdod, Israel, Feb. 18, 2021 (GLOBE NEWSWIRE) -- Integrity Applications, Inc. (www.integrity-app.com) (IGAP), innovator of GlucoTrack®, a non-invasive device for measuring glucose levels in people with Type 2 diabetes and prediabetes, issued a letter to its shareholders providing an update on its business.
Dear Fellow Shareholders,
2020 was an important operational year for the Company, even in light of the widespread effects of the COVID-19 pandemic. We hope all of you have stayed healthy and safe during these difficult times. This pandemic has exposed the need for the adoption of innovative digital health technologies for chronic diseases and we believe more than ever that the GlucoTrack platform that we are building will be well suited for addressing the critical market need as it relates to those suffering with diabetes and prediabetes.
Talent development, recruiting and organizational health have been a critical focus of the Company over the last 12 months. We are thrilled to have attracted high-quality individuals to the Company, each of whom bring extensive experience in their respective fields. We have bolstered our Senior Management with the recruitment of Erez Ben-Zvi, a highly experienced MedTech development professional who joined us last year as Vice President of Product, and recently took on the additional role of General Manager, and Shalom Shushan, a seasoned executive who joined us as Chief Technology Officer. Paul V. Goode PhD, who has a decorated career developing innovative medical technologies, including at DexCom and MiniMed, joined our board of directors. Several highly talented and accomplished executives joined the Company as senior advisors to the Board. These include Yair Briman, the former CEO of Philips Healthcare Informatics, Daniel McCaffrey MBA MA, a world-renowned behavioral scientist and digital health expert currently at Samsung Health and formerly of Dexcom, and Dr. Alexander Raykhman PhD, a measurement and artificial intelligence expert. We intend to continue to invest in our talent and to expand and strengthen all areas within the company.
We continue to manage our burn rate and reduce debt that had accumulated under prior management. Together with the
The Company has performed a top-down analysis of the current GlucoTrack model to identify areas of potential enhancement, as it relates to the platform, integrations, sensor technologies, accuracy as well as costs to manufacture. The result of this comprehensive review is an accelerated development plan for the next generation GlucoTrack, what we refer to as GT 2.0. GT 2.0 will be a completely wireless and rechargeable earclip to be paired with a smartphone, with more capabilities and features, increased accuracy, significantly greater margins for the Company and lower cost to the end-user as compared to the current model GlucoTrack. Management is executing and GT 2.0 is now under development.
As previously reported, we have made significant progress towards receiving insurance reimbursement in the Netherlands. With our new accelerated development plan for GT 2.0, with all of the expected advantages over the current GlucoTrack model, it made clear to us that introducing GT 2.0 rather than the current version will serve the diabetes market and the Company more effectively. We are currently working with our European partners on the roadmap for distribution of GT 2.0 when completed and ready to market.
In addition to the European markets, the Company is now focused on the U.S. market as well, including building out its U.S. go-to-market strategy and planning the required FDA clinical trials and field testing to support its entrance into the market. The Company is currently in the process of identifying clinical sites in the U.S., interviewing Contract Research Organizations (CRO’s), and forming its Scientific and Medical Advisory Boards. We intend to build out a team to support the U.S. activities, while continuing our technology development in our R&D facility located in Israel.
We are optimistic about the future and expect the next 12-18 months to be an exciting, event driven period for the Company and we look forward to updating you on an ongoing basis on our progress.
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. (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 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.
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