Rutherford, NJ, March 14, 2023 (GLOBE NEWSWIRE) — GlucoTrack, Inc. (Nasdaq: GCTK) (“GlucoTrack” or the “Company”), a medical device and digital health platform company focused on diabetes and prediabetes, announced today that Paul V. Goode, PhD, President and Chief Executive Officer has provided a shareholder update letter.
To Our Valued Shareholders,
At the outset, we would like to express our gratitude to all of our shareholders for their continued support of the Company. We remain fully committed to executing our business strategy and could not be more excited about the outlook for the Company. We welcome this opportunity to share our thoughts and insights as to the developments of the past year and our plans going forward.
Our vision at Glucotrack is to become a leader in the diabetes market by providing a range of products and services addressing multiple verticals; those with Type 1 and Type 2, insulin dependent and non-insulin dependent, and prediabetes. The management team we have built has deep expertise in a variety of disciplines, including glucose monitoring, sensor development, and novel insulin delivery systems. Our senior leadership hail from leading companies in the field, including Dexcom, Medtronic, Samsung Health, and Insulet.
While our initial product, the Glucotrack non-invasive device is intended for the Type 2, non-insulin dependent market, in the fourth quarter of 2022 we added to our product portfolio by acquiring technology for an implantable continuous glucose monitor that is intended for the Type 1 insulin dependent market. While we are focused on these two current product programs, we continue to explore new avenues for growth and innovation by reviewing additional technologies within the diabetes market for strategic partnerships or acquisitions.
We continue to make progress on our flagship Glucotrack non-invasive monitor. Our development team began our Gen 2 redesign program as a project to miniaturize the Gen 1 technology into a smaller wireless ear clip that would connect to a smartphone via Bluetooth. As our miniaturization project progressed, the glucose sensing landscape evolved as continuous glucose monitoring (CGM) devices in the market reached similar accuracy as the conventional fingerstick blood glucose monitoring (BGM) devices. This inevitably raised the regulatory bar for any glucose sensor performance, as regulatory bodies such as the FDA could now point to the accuracy levels of BGM and CGM alternatives already available to the patient. In addition, the Company recognized the advent and significant growth of digital health. Particularly, CGM companies set a new bar for a mobile experience with diabetes data and its associated cloud management, with BGM companies quickly following. Also, from a user experience perspective, while a 60 second measurement time may have been acceptable to the market in the past, we determined this is no longer the case, and that we needed to significantly reduce the time it took to complete a measurement.
As a result of these changing dynamics, we concluded that the Gen 2 project scope not only had to reduce the size of our device, but also had to improve the user experience and to significantly improve sensor accuracy. Accordingly, the Company had to return to a research mode to design, develop, and test a new, more innovative device that would meet this criteria and to invest in software development to ensure that the Gen 2 product would be supported by both iOS and Android devices with a cloud-based infrastructure.
By the end of 2022 we had a clinical prototype of a newly designed system. This system utilizes ultrasound-only sensor technology, reduces the overall cost and complexity of the device, and reduces the measurement time from 60 seconds to 2 seconds. Initial testing produced promising results, suggesting measurement accuracies could be obtained similar to those of conventional, already in-the-market CGM technologies. Continued testing however, exposed certain human factors that complicated consistent sensor placement. We have identified several mechanical techniques to address this challenge and we expect to complete this process and begin our first-in-human (FIH) study in the second quarter of 2023. Collecting data for sensor characterization and algorithm development will be the primary goals of the FIH study. The results of this study will also drive the development of the commercial version of the device, which is expected to commence late in the third quarter of 2023. Once the development of the commercial device version is complete, we intend to conduct a scaled down version of the FDA pivotal trial to resolve any lingering device performance or human factors issues prior to executing the larger pivotal trial for FDA submission.
In the fourth quarter of 2022 we acquired certain IP relating to an implantable continuous glucose monitor. We designed and developed a laboratory CGM sensing system, integrated into a cloud-based automated data collection system and a prototype model of this system was implemented and validated. We also designed, manufactured, and tested a prototype sensor lead. In addition, we have identified and consummated key vendor relationships with expertise in designing and manufacturing implantable leads and electronics, and we are developing a sensor life simulation system that will take real bench data as inputs and predict total enzyme longevity.
Our focus now is to complete the feasibility assessment of achieving a multi-year implant life. In parallel, we have initiated an implantable electronics design effort. A paper-based design has been completed, and a physical mock-up is expected in the second quarter of 2023, with a targeted prototype design for an animal study to commence in the third quarter of 2023.
By the end of 2023 we intend to have completed the feasibility assessment based on bench data and sensor life modeling/prediction, have bench data (in solution) demonstrating at least six months of sensor life without significant degradation, have animal data demonstrating at least three months of sensor life without significant degradation, and have initiated a human clinical device/system design and development program.
We remain encouraged by our progress and the potential of our novel solutions for improving healthcare outcomes among patients with diabetes and prediabetes. On behalf of our dedicated management team and employees, I would like to thank you for your trust and support over this past year. We are excited by our prospects in 2023 and look forward to your continued support.
Paul V. Goode, PhD
President and Chief Executive Officer
GlucoTrack, Inc. (NASDAQ: GCTK), (formerly known as Integrity Applications, Inc.) is focused on the design, development, and commercialization of novel technologies for people with diabetes and prediabetes. The Company’s initial product, GlucoTrack®, is a proprietary non-invasive glucose monitoring device designed to obtain glucose level measurements without the pain, incremental cost, difficulty, or discomfort of conventional invasive finger stick devices. For more information, please visit and http://www.glucotrack.com.
Investor Contact: [email protected]
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 GlucoTrack’s 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 GlucoTrack’s results include, but are not limited to, the ability of GlucoTrack 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 GlucoTrack’s 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, 2021 as filed with the SEC on March 31, 2022.