Rutherford, NJ, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Glucotrack, Inc. (Nasdaq: GCTK) (“Glucotrack” or the “Company”), a medical device company focused on glucose monitoring technologies for people with 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,
As we near the end of 2023, we would like to express our gratitude for your continued support of the Company. We welcome this opportunity to announce a redefined strategic direction as we take a step closer to achieving our vision of becoming a leader in the diabetes market by providing a range of unique products and services addressing multiple categories.
In recent years, the diabetes market has experienced a significant transformation, driven by the growth of continuous glucose monitoring (CGM). As momentum for CGM has continued to intensify, the market has been shifting away from point-in-time (i.e. non-continuous) glucose monitoring. With our goal of commercializing market-leading diabetes technology, the Company is shifting its focus from non-invasive point-in-time glucose monitoring to continuous glucose monitoring technology within our portfolio. We are excited about this transition, which expands our commercial opportunity into both the type 1 and type 2 diabetes market and ensures we are on the optimal path for the long-term growth and sustainability of the Company.
Within the clinical landscape, the expanding body of clinical evidence supporting the value of CGM in people with type 1 and type 2 diabetes has contributed to, and even driven, interest and utilization of the category within the patient and healthcare provider communities. Conversely, recent changes in the clinical landscape for blood glucose monitoring (BGM), which is a type of point-in-time glucose monitoring, have called into question its value for non-insulin using people with type 2 diabetes, the target population for non-invasive point-in-time glucose monitors.
New clinical guidelines were published in August on the diagnosis and management of diabetes, titled, “Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus.” These guidelines were reviewed by the Evidence Based Laboratory Medicine Committee and the Board of Directors of the American Association for Clinical Chemistry as well as the Professional Practice Committee of the American Diabetes Association (ADA) and were published in Clinical Chemistry. This was the first update to the guidelines since 2011 and included major shifts in clinical thinking. In particular, the guidelines state that “routine use of BGM is not recommended for people with type 2 diabetes treated with diet and/or oral agents alone”1. This is a notable change from the 2011 guidelines, which said the BGM “may help achieve better control, particularly when therapy is initiated or changed” in this population2. Additionally, the ADA Standards of Care 2023 state “in people with type 2 diabetes not taking insulin, routine glucose monitoring may be of limited additional clinical benefit.”3 These new clinical guidelines suggest that use of point-in-time glucose monitoring should not focus on non-insulin using people with type 2 diabetes who are treated with diet and/or oral agents. Thus, these new guidelines question the value of non-invasive point-in-time glucose monitoring for its key patient population and thus cast uncertainty about the size of the commercial opportunity.
An additional shift has occurred in the access and coverage landscape where there has been expansion of insurance coverage for CGM beyond the type 1 diabetes market and into the insulin using type 2 diabetes market, driven by the considerable body of clinical evidence demonstrating CGM utility in this population. Earlier this year, the Centers for Medicare & Medicaid Services (CMS) granted CGM coverage for all people with diabetes who are on insulin or who meet a defined hypoglycemia profile. Our expectation is that CGM utilization will continue to expand in this population given the favorable reimbursement environment while point-in-time glucose monitoring slowly declines. This shift in the landscape demonstrates the increasing market demand and acceptance for continuous glucose monitoring.
Within the glucose sensing competitive landscape, CGM devices have reached similar accuracy as BGM devices, fueling their market acceptance and utilization. In the last shareholder update, we had recognized that this would raise the regulatory bar for any non-invasive glucose sensor performance. To date, our understanding is that the current generation of BGMs and CGMs have attained levels of accuracy and performance that outpace all known non-invasive point-in-time technologies that have progressed to real-world evaluations. As a result, the ability to achieve regulatory approval remains elusive and a substantial challenge for many non-invasive glucose sensor companies. This is further evidence supporting the transition of our business strategy to the CGM category, where current and future performance standards are more clearly defined, accepted and attainable.
Today represents an important step in Glucotrack’s journey as we reset our priorities, improve our commercial outlook and refine our business strategy to focus on our implantable CGM technology. We have significantly advanced the development program for the implantable CGM since launching its development in late Q4 last year and having recently achieved several key milestones. In July, we announced the completion and positive results of a laboratory-based feasibility study demonstrating that the CGM sensor is capable of measuring glucose for at least two years post-implant. In October, we announced the progression into initial preclinical animal studies which has established that the sensor functions as expected after the implant procedure and 30 days thereafter. Subsequently, we have initiated preparations for long-term preclinical studies on sensor performance that are expected to start in late Q4 of this year.
The implantable CGM is designed to be truly long-term, with a sensor longevity of at least two years, with no on-body wearable component, a once-only calibration event and a simple insertion and removal procedure. This impressive feature set differentiates our system from currently available CGM options and will be a unique offering in the diabetes market. Our implantable CGM development program continues to meet and even outperform our expectations and we remain confident as we move towards regulatory approval and commercialization of this innovative technology.
At Glucotrack, we remain committed to commercializing novel solutions for improving healthcare outcomes among people with diabetes and prediabetes and to exploring additional acquisitions and strategic collaborations to grow our portfolio. With this new direction, we are better positioned to deliver strong business and financial results for the Company and our shareholders.
On behalf of our dedicated leadership team and employees, I would like to thank you for your continued trust and support. We are very excited by what lies ahead for the duration of 2023, into 2024 and beyond and we look forward to your continued support.
Paul V. Goode, PhD
President and Chief Executive Officer
About Glucotrack, Inc.
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 is currently developing a long-term implantable continuous glucose monitoring system for people living with diabetes. For more information, please visit http://www.glucotrack.com.
Investor Contact: investors@glucotrack.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 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, 2022 as filed with the SEC on March 31, 2023.
1David B Sacks, Mark Arnold, George L Bakris, David E Bruns, Andrea R Horvath, Åke Lernmark, Boyd E Metzger, David M Nathan, M Sue Kirkman, Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus, Clinical Chemistry, Volume 69, Issue 8, August 2023, Pages 808–868, https://doi.org/10.1093/clinchem/hvad080
2David B Sacks, Mark Arnold, George L Bakris, David E Bruns, Andrea Rita Horvath, M Sue Kirkman, Ake Lernmark, Boyd E Metzger, David M Nathan, Guidelines and Recommendations for Laboratory Analysis in the Diagnosis and Management of Diabetes Mellitus, Clinical Chemistry, Volume 57, Issue 6, 1 June 2011, Pages e1–e47, https://doi.org/10.1373/clinchem.2010.161596
3ElSayed, N.A., Aleppo, G., Aroda, V.R., Bannuru, R.R., Brown, F.M., Bruemmer, D., Collins, B.S., Hilliard, M.E., Isaacs, D., Johnson, E.L. and Kahan, S., 2023. 7. Diabetes technology: standards of care in diabetes—2023. Diabetes Care, 46(Supplement_1), pp.S111-S127.
