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, PhDPresident 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.
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