Clinical Trial

Validating AI models and expanding cardiovascular pathology datasets through strategic clinical partnerships

Overview

We are planning comprehensive clinical trials in collaboration with our partner clinics to validate our AI models and significantly expand our cardiovascular pathology datasets. These trials will provide the clinical evidence needed to bring our screening platform to market.

Trial Objectives

AI Model Validation

Validate the accuracy and reliability of our AI models for AMD, Diabetic Retinopathy, Glaucoma, and Stroke detection

Dataset Expansion

Expand our cardiovascular pathology datasets with diverse, clinically-validated fundus images

Clinical Integration

Test real-world integration of our platform in clinical settings with actual patient workflows

Performance Metrics

Establish sensitivity, specificity, and predictive value metrics for regulatory approval

Partner Clinics

Our clinical trials will be conducted in collaboration with leading ophthalmology and emergency care facilities:

Retina Clinic, Bucharest Active Partner

Working with Dr. Florian Balta, a top ophthalmologist, to validate our retinal pathology detection models in a specialized clinical setting.

Spitalul Universitar de Urgență București In Discussion

Bucharest University Emergency Hospital. Partnership would enable validation of stroke detection models in an emergency care context with diverse patient populations.

Visioofta In Discussion

Partnership discussions ongoing to expand our clinical trial network and access additional patient populations for model validation.

Trial Scope

The clinical trials will focus on:

Model Validation: Testing our AI models against gold-standard clinical diagnoses to establish accuracy metrics
Cardiovascular Dataset Expansion: Collecting and annotating fundus images with confirmed cardiovascular pathology diagnoses
Stroke Risk Assessment: Validating our stroke detection algorithms using our 68,000-image dataset and new clinical data
Multi-Pathology Screening: Testing simultaneous detection of multiple conditions (AMD, Diabetic Retinopathy, Glaucoma, Stroke) in a single screening session
Real-World Performance: Evaluating model performance in actual clinical workflows with varying image quality and patient demographics

Expected Outcomes

Upon completion of the clinical trials, we expect to:

Establish clinical validation for regulatory approval (CE marking, FDA pathways)
Expand our cardiovascular pathology dataset significantly
Publish peer-reviewed research on AI-powered retinal screening for stroke detection
Demonstrate real-world clinical utility and cost-effectiveness
Build a strong evidence base for insurance reimbursement and clinical adoption

Timeline

Clinical trials are planned to begin following successful pilot validation and will run concurrently with our platform development. The trials will be conducted in phases, starting with model validation and progressing to larger-scale multi-center studies.

For more information about our clinical trial protocols and participation opportunities, please contact us.

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