8-K: Glucotrack and OneTwo Analytics Announce Positive Final Results from First-in-Human Study for Implantable Continuous Blood Glucose Monitor

Glucotrack, Inc. announced positive final results from its first-in-human clinical study for its implantable Continuous Blood Glucose Monitor, demonstrating strong accuracy with a 7.7% MARD and excellent safety.

Summary

• Glucotrack, Inc. (Nasdaq: GCTK) and OneTwo Analytics presented positive final results from their first-in-human clinical study for Glucotrack's long-term, implantable Continuous Blood Glucose Monitor (CBGM) at the American Diabetes Association's (ADA) 85th Scientific Sessions.
• The study, conducted between December 13, 2024, and January 31, 2025, in São Paulo, Brazil, involved ten participants with Type 1 or Type 2 diabetes on intensive insulin therapy.
• All primary and secondary endpoints were met, demonstrating excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7% across 122 matched pairs.
• The device achieved a 99% data capture rate and reported no procedure or device-related serious adverse events.
• Analysis using the Diabetes Technology Society Error Grid showed 92% of CBGM measurement values in the green zone and none in unsafe zones, indicating very high clinical accuracy.
• The CBGM measures glucose directly from blood, eliminating the typical lag time associated with traditional continuous glucose monitoring systems that measure interstitial fluid.
• The system successfully remained in place throughout the study period and was removed at completion, with patients followed for 7 days post-removal.
• Glucotrack plans to initiate a long-term early feasibility study in Q3 2025 to further evaluate safety and performance over an extended period.

Sentiment

Score: 8

Explanation: The document reports highly positive clinical trial results for a novel medical device, meeting all endpoints with strong accuracy and safety data. This represents a significant milestone for the company and its product development.

Positives

• The first-in-human clinical study met all primary and secondary endpoints, validating the safety and performance of the CBGM.
• Demonstrated excellent accuracy with a Mean Absolute Relative Difference (MARD) of 7.7%, which is comparable to leading CGM systems.
• Achieved a high 99% data capture rate, indicating reliable performance.
• No procedure or device-related serious adverse events were reported, confirming the safety profile.
• Clinical accuracy was very high, with 92% of measurements in the green zone and none in unsafe zones according to the Diabetes Technology Society Error Grid.
• The CBGM measures glucose directly from blood, eliminating the lag time associated with interstitial fluid-based monitors.
• Designed for a three-year sensor life, offering a long-term solution for diabetes management.
• The system is fully implantable with no on-body wearable component, providing a less intrusive and more convenient solution.
• Requires minimal calibration, simplifying patient use.
• The device was successfully implanted and removed, and remained in place throughout the study period.

Risks

• 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 U.S. Food and Drug Administration (FDA) approval.
• Risks relating to enrollment of patients in, and the conduct of, future clinical trials.
• Risks relating to Glucotrack's future distribution agreements.
• Risks relating to its ability to hire and retain qualified personnel, including sales and distribution personnel.
• Other additional risk factors described in Glucotrack's filings with the U.S. Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024.

Future Outlook

Glucotrack expects to initiate a long-term early feasibility study in Q3 2025. This study will evaluate the safety and performance of the CBGM over an extended period, bringing the technology closer to its goal of providing patients with a less-intrusive alternative to continuous glucose monitoring.

Management Comments

• "This study represents an important milestone validating our CBGM technology’s potential. With a MARD of 7.7%, which is comparable to leading CGM systems but with direct blood measurement instead of interstitial fluid, we’re advancing our novel technology into further clinical trials, taking us closer to providing patients with a long-term, less burdensome solution for diabetes management. We are excited to be sharing our data at this important industry congress." Paul V. Goode, PhD, President and Chief Executive Officer of Glucotrack.
• "We’re proud to have applied our clinical analytics expertise to validate the performance of Glucotrack’s innovative CBGM technology. The results demonstrate excellent safety and accuracy profiles that could meaningfully improve diabetes care." Lars Cederblad, Chief Executive Officer of OneTwo Analytics.

Industry Context

This announcement highlights a significant advancement in diabetes management technology. By developing a fully implantable continuous blood glucose monitor that measures glucose directly from the blood, Glucotrack aims to overcome the lag time inherent in traditional interstitial fluid-based continuous glucose monitors. This innovation positions the CBGM as a potentially less burdensome and more convenient long-term solution for people with diabetes, offering a distinct advantage over existing wearable CGM systems and potentially disrupting the current market for diabetes monitoring devices.

Comparison to Industry Standards

• The Glucotrack CBGM achieved a Mean Absolute Relative Difference (MARD) of 7.7%, which Glucotrack states is "comparable to leading CGM systems."
• Unlike traditional continuous glucose monitors that measure glucose from interstitial fluid, the Glucotrack CBGM measures directly from the blood, eliminating typical lag time.
• The system is designed for a three-year sensor life, offering a significantly longer duration of use compared to most current CGM systems which require frequent sensor replacement (e.g., every 10-14 days).
• The CBGM is a fully implantable system with no on-body wearable component, differentiating it from current market leaders like Dexcom and Abbott's FreeStyle Libre, which are external wearable devices.

Stakeholder Impact

• **Shareholders/Investors:** Positive clinical trial results could increase investor confidence and potentially lead to an increase in share price due to reduced development risk and enhanced product potential.
• **Patients (People with Diabetes):** The development of a long-term, implantable, accurate, and less intrusive continuous blood glucose monitor could significantly improve their quality of life and diabetes management.
• **Healthcare Providers:** The technology offers a new tool for more precise and continuous glucose monitoring, potentially leading to better patient outcomes and simplified disease management.
• **Competitors:** This innovative technology, if successful in further trials and commercialization, could pose a competitive challenge to existing CGM manufacturers by offering a differentiated solution.

Next Steps

• Initiate a long-term early feasibility study in Q3 2025 to evaluate safety and performance over an extended period.

Key Dates

Keywords

Glucotrack, Continuous Glucose Monitor, CBGM, Diabetes, Medical Device, Implantable, Clinical Study, Blood Glucose, First-in-Human, OneTwo Analytics, ADA, GCTK