FLUIDDA

Executive Summary

FLUIDDA is a Belgian medtech company that has established itself as a global leader in Functional Respiratory Imaging (FRI), a proprietary technology that combines high-resolution CT scans, computational fluid dynamics, and artificial intelligence to create patient-specific 3D models of the lungs. These models visualize regional lung function, enabling precise assessment of respiratory diseases. The company operates under a dual business model: as a Contract Research Organization (CRO) supporting pharmaceutical companies in clinical trials, and as a diagnostic software provider for healthcare professionals. Since its founding in 2005, FLUIDDA has built a strong intellectual property portfolio and collaborated with leading academic and industry partners, positioning itself at the intersection of medical imaging, computational modeling, and AI-driven diagnostics. The respiratory diagnostics market is expanding rapidly, driven by the need for personalized medicine and non-invasive monitoring. FLUIDDA’s FRI technology offers significant advantages over traditional spirometry, providing detailed regional analysis that can improve drug development and patient management. While the company remains private, its CRO business generates recurring revenue, and its software has the potential to become a standard tool in pulmonology. Key upcoming catalysts include potential regulatory clearances for expanded clinical use, new partnership announcements with major pharmaceutical companies, and the publication of clinical validation studies. With its differentiated technology and growing market adoption, FLUIDDA represents a compelling opportunity in the diagnostic space.

Upcoming Catalysts (preview)

• Q3 2026FDA 510(k) clearance for FRI diagnostic software in the U.S.60% success
• Q3 2026New CRO partnership with a top-10 pharmaceutical company for a respiratory clinical trial50% success
• TBDPublication of positive clinical validation data in a peer-reviewed journal (e.g., involving COPD or asthma)70% success