IGAP Integrity Applications Inc

 Integrity Applications, Inc. (www.integrity-app.com) (NASDAQ: IGAP), innovator of GlucoTrack®, a non-invasive device for measuring glucose levels in people with Type II diabetes and prediabetes announced today that Paul V. Goode, PhD, President and Chief Executive Officer has provided a message and year-to-date shareholder update letter. 

To our valued shareholders:

On November 1st, I stepped down from my position on the board to become President and Chief Operating Officer of the company. In connection with our Nasdaq listing, I was asked to take on the role of Chief Executive Officer, to be effective today, a request that I happily accepted. These moves reflect both my belief in GlucoTrack as well as my firm commitment to driving its progress forward. I intend to bring my experience working with novel and innovative diabetes management devices at companies such as MiniMed and Dexcom to successfully bring GlucoTrack to market. I am excited and thankful for the company’s board of directors’ vote of confidence in me, and it is a great honor to be part of the company's executive management team.

This has been a remarkable year for us, as we continued to advance our R&D, technology, clinical programs and add extremely talented and capable members to our team. I remain confident that we are developing a groundbreaking and innovative solution to managing Type II diabetes and prediabetes, which has the potential to change the lives of the many afflicted. I am very grateful to all who continue to support our vision.

On December 10th we successfully completed our uplisting to Nasdaq. We believe this listing will enable the company and its shareholders greater access to liquidity, increased corporate visibility and a broader shareholder base. The company is now in the process of completing its corporate name change to GlucoTrack, Inc., along with a new ticker symbol. This name change marks a new chapter in the company’s growth and development, and we believe that it is strategic in aligning our corporate identity with our flagship product.

We are proud to have achieved a great deal in a short amount of time while maintaining very strong fiscal control over expenses and closely managing our balance sheet and cash position. In addition, as disclosed in September, we have a $100.0 million shelf registration on file and effective with the SEC, providing us with increased financial flexibility and more efficient access to the capital markets to support our future growth opportunities.

Talent development, recruiting and organizational health continue to be a critical focus for us, and we have been fortunate to add several exceptionally qualified individuals to the company this year.

Under the leadership of Erez Ben-Zvi, General Manager of our advanced technology center located in Israel, we have built a team with a deep understanding and experience in unique sensor and mobile/cloud-based technologies. This new team has the experience and expertise to accelerate the development of our next generation product, GlucoTrack 2.0, as well as future iterations.

In July, Luis J. Malavé joined as an independent board member. He has spent his career driving innovation in diabetes technologies at several high-profile companies, including leadership positions at MiniMed, as Chief Operating Officer of Insulet Corporation, and as President of EOFlow, Inc. Luis has been an invaluable addition to the company’s board of directors.

Recently, James P. Thrower, PhD, joined the company as Vice President of Engineering. James will be leading the product development activities here in the United States in coordination with our Israeli advanced technology team led by our Chief Technology Officer, Shalom Shushan. I worked with James in the early years at DexCom, and his talent will be of immense value to us as we continue to expand our operations here in the United States.

In addition, world-renowned endocrinologist, David C. Klonoff, MD, joined the company as Chair of our Scientific Advisory Board. Dr. Klonoff has been a Principal Investigator on over 120 clinical trials of diabetes drugs and devices, as well as Editor in Chief of the Diabetes Science Technology journal. He is advising on our clinical and regulatory strategies, assisting with clinical research, and will be assisting in the design of our U.S. clinical trials, and in our FDA submission.

Earlier this year, after concluding our GlucoTrack 1.0 pilot programs in the Netherlands, the company made a strategic decision to focus on the advancement and introduction of GlucoTrack 2.0, our next generation device. GlucoTrack 2.0 will incorporate significant improvements to form factor and sensing technology, while providing wireless connectivity.

GlucoTrack 2.0 form factor will shed the wired handheld unit from the GlucoTrack 1.0 design to be a completely wireless earclip with Bluetooth connectivity for pairing directly with the user’s own mobile device (smartphone and/or tablet). The earclip will be rechargeable and stored in a small carrying case for storage and recharging when not in use, similar to wireless earbuds. This facilitates the smallest earclip design by reducing battery size requirements. Eliminating the cabled main unit hardware is also expected to significantly lower our manufacturing costs. This will enable an attractive end-user price point while maintaining healthy margins for the company.

GlucoTrack 2.0 will incorporate improvements to our core sensing technology that will improve system performance. More specifically, the GlucoTrack 1.0 sensor system will be modified with various circuit and parameter adjustments leveraging the state-of-the art in key sensing technology. This modified sensing system will be further augmented with additional new supportive sensing techniques. The combination of these changes will improve overall glucose estimation accuracy while also reducing the time required to take a measurement. These improvements will be accompanied by a set of next generation algorithms for user self-calibration, outlier detection, and calculation of key values such as glucose concentration, time in range, and HbA1c.

The GlucoTrack 2.0 wireless mobile platform will support capturing anonymized data that can leverage novel machine learning (AI) and data analytic techniques to facilitate device iterations and glucose sensing accuracy improvements. In addition, mobile device pairing will facilitate data transfer to electronic medical records (EMRs) used by managing physicians to effectively treat their patients. Moreover, this data can provide a potential revenue stream for valuable T2DM and pre-T2DM de-identified patient data that can be used by third-party organizations such as pharma, insurance, and others.

We believe GlucoTrack 2.0 has the potential to create a ground-breaking shift in the diabetes and prediabetes industry and become a leader in this market.

All of our engineering, software, and clinical programs for the upcoming GlucoTrack 2.0 are progressing rapidly. The engineering design and fabrication of the initial GlucoTrack 2.0 prototype version is complete with the electronics and earclip units currently in lab testing which is expected to be completed in Q1 2022. Iterative improvements for all electronic components are already underway and also expected to be ready for in-house testing in Q1 2022. Our mobile app software development has progressed and is now undergoing initial human factors testing in both Israel and the U.S. In addition, our in-house testing of the cloud server software is expected to be completed in late Q1 2022. Dr. Klonoff is collaborating diligently with the company on planning for our U.S. clinical trials. Key clinical centers and supportive clinical resources have been recruited in preparation for initial clinical activity in Q2 2022. While the exact timing of when we expect our U.S. clinical trials to be completed and submitted to the FDA is still dependent on several factors, we are moving as expeditiously as possible.

These are exciting times at the company. There is much to be proud of, and yet much more to do. We believe we have the potential to become a leader in diabetes and prediabetes management and help people live longer and better through our innovative technology. Our deep appreciation goes out to our employees, the board of directors and our shareholders for their continued support. We greatly appreciate the trust you have placed in us and look forward to reporting our continuing progress during 2022.

Sincerely, Paul V. Goode, PhDPresident and Chief Executive Officer

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.

About Integrity Applications, Inc.

Integrity Applications, Inc. (NASDAQ: 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

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 13, 2021.