Stroke is the second leading cause of death and a major source of long-term disability globally. Among stroke types, Large Vessel Occlusion (LVO) is the most severe and time-sensitive. Timely intervention, particularly mechanical thrombectomy, can greatly improve outcomes—but only if patients are rapidly and correctly identified.
Existing prehospital triage methods, typically clinical scales, lack sufficient accuracy, often leading to under- or over-triage, treatment delays, and inefficient use of stroke centers. While Mobile Stroke Units (MSUs) are effective, they remain expensive and largely unavailable, especially in rural or underserved regions.
The LVOCheck project addresses this gap with a portable, AI-supported diagnostic tool designed for ambulance or emergency use. It identifies suspected LVO stroke patients in under 15 minutes by combining three blood-based biomarkers (NT-proBNP, D-Dimer, H-FABP) with a machine learning algorithm accessible via a mobile app, delivering real-time decision support to emergency responders.
Key achievements:
• Developed a point-of-care lateral flow assay for quantifying the biomarker panel
• Created an AI-based clinical decision support (CDS) app integrating biomarkers and clinical indicators
• Conducted two clinical studies (Spain and Germany) with over 800 patients, validating performance in real-world prehospital settings
• Achieved 64–74% sensitivity at 93% specificity, significantly outperforming current clinical triage scores
• Initiated FDA Breakthrough Device Designation submission and advanced CE marking preparation under EU IVDR
• Implemented a QMS compliant with ISO 13485:2016, supporting regulatory scalability
These results confirm LVOCheck’s value as a disruptive diagnostic solution for stroke triage. The system is intuitive, scalable, and fits seamlessly into existing emergency workflows, enabling faster decisions, improved outcomes, and reduced system costs.
Future potential:
LVOCheck can transform stroke triage worldwide, particularly in areas lacking imaging or stroke expertise. By improving access to thrombectomy, it may prevent irreversible brain damage and reduce long-term disability. Health economic modelling suggests meaningful cost savings per patient by streamlining care pathways and avoiding unnecessary transfers.
Moreover, LVOCheck promotes equity in stroke care, bringing cutting-edge diagnostics to underserved regions. Its portability makes it suitable for ambulances, remote clinics, and low-resource settings. The platform also holds promise for expansion into other emergency or cardiovascular indications, leveraging its biomarker-AI synergy.
Conclusion:
LVOCheck represents a major innovation in stroke diagnostics. With strong validation, regulatory momentum, and growing interest from investors and clinical partners, ABCDx is positioned to scale deployment across Europe, North America, and the Gulf region. Support from the EIC Accelerator has been instrumental in translating a bold scientific concept into a market-ready solution with global impact.
