• 4DMedical's CT:VQ is the world's first non-contrast, CT-based ventilation-perfusion imaging technology
• CT:VQ eliminates the need for radiotracers, streamlining workflows and improving patient access
• CT:VQ leverages the extensive installation base of CT scanners, democratizing access to advanced VQ imaging

4DMedical Limited (ASX:4DX), a global leader in respiratory imaging technology, has announced that its ventilation-perfusion product, CT:VQ, has received U.S. Food and Drug Administration (FDA) 510(k) clearance. This represents a historic moment in respiratory diagnostics, as CT:VQ becomes the world's first non-contrast imaging modality capable of delivering quantitative ventilation and perfusion analysis directly from standard chest CT scans. CT:VQ revolutionizes ventilation-perfusion imaging by eliminating the need for radiotracers, streamlining scheduling and improving patient access by removing the associated complex handling requirements and regulatory constraints. Traditional nuclear VQ imaging workflows are simplified through CT:VQ by seamless integration with existing CT protocols, requiring no additional infrastructure or specialized equipment. CT:VQ delivers superior image resolution and precise quantification while eliminating artifacts commonly associated with radiotracer clumping or contrast leakage. Most significantly, CT:VQ leverages the extensive installation base of approximately 14,500 CT scanners across the U.S. healthcare system, extending advanced VQ imaging capabilities to rural and smaller healthcare facilities that may lack nuclear medicine infrastructure. 4DMedical conducted extensive clinical testing to prove that CT:VQ produces the same diagnostic results as SPECT, the current gold standard for nuclear ventilation-perfusion imaging, while offering significant practical advantages. The robust clinical evidence positions CT:VQ for broad market adoption across the 14,500+ CT scanners already installed in U.S. healthcare facilities.

With over one million nuclear VQ scans performed annually in the U.S., CT:VQ has an initial addressable market of USD $1.1 billion. 4DMedical believes it can rapidly capture a significant part of this market, and over time expects to displace 100% of all nuclear VQ scans.

The introduction of CT:VQ into the market is expected to drive long-term growth in demand for ventilation-perfusion scans beyond the traditional nuclear VQ indications, as the technology enables expanded applications in disease monitoring, treatment planning, and population health screening.