Evidence & Validation

Objective: Summary of existing evidence and validation strategy.

TL;DR: Evidence Status

• Existing: Prospective pilot (2024) demonstrated execution capability and biomarker signal.
• Goal: Conduct rigorous RCT with TA3 to prove HF/Post-MI efficacy.

1. Prospective Pilot (2024)

• Context: Early prototype validation.
• Design: Prospective cohort, N=13 clinician users.
• Intervention: AI-guided lifestyle and preventive medicine.
• Key Finding: Observed signal for lipid biomarker improvement (Total/LDL Cholesterol).
• Significance: Validated the "Human-in-the-loop" workflow and data capture pipeline.

2. Operational Maturity

We are not "beta." The platform is deployed in production environments:

• Private Multi-specialty Clinic: Full clinical decision support workflow.
• Pediatric Medical Center: Complex care coordination and documentation.
• Note: These sites prove the software creates value and is stable, even outside the cardiology domain.

3. What We Proving With You (ADVOCATE)

We are partnering to generate specific evidence for:

1. Clinical Efficacy: Reduction in re-hospitalization for HF/Post-MI.
2. Safety: Non-inferiority to human-only care.
3. Efficiency: Reduction in clinician time-per-patient.

Last Updated: 2026-01-20