GlucoTrack (GCTK) investor relations material

Market opportunity and unmet needs

• Global CGM market valued at $13.4B in 2025, with ~50% of eligible patients still not using CGM.

• Diabetes prevalence is high, with 40 million Americans affected and over 25% of healthcare spending linked to diabetes.

• High-needs diabetes segments remain underserved despite CGM expansion, especially among type 2 non-insulin users.

• Patients report dissatisfaction with current CGMs due to sensor wear time, accuracy, and device burden.

Product innovation and differentiation

• CBGM system is fully implantable, requires no wearables, and offers 3-year sensor longevity.

• Direct blood sensing provides real-time, blood-true accuracy and eliminates skin adhesives and frequent sensor changes.

• Designed using FDA-approved components and techniques from cardiac monitoring to reduce regulatory risk.

• 20-minute outpatient procedure for device placement, with simplified management and no ongoing reordering.

Clinical validation and regulatory pathway

• First-in-human feasibility study showed reliable continuous glucose monitoring with MARD of 5.9% and no serious adverse events.

• Early data demonstrated strong sensor accuracy (MARD 7.7%) and 91.6% of readings within safe error grid zones.

• Clinical and regulatory timeline targets FDA DeNovo 510k submission after 1-year pilot IDE data, with pivotal trial and market launch planned by 2029.