- The disease
- Lung ventilation analysis is the measurement of how air moves through the airways and into different regions of the lungs. Abnormal ventilation patterns are associated with conditions including chronic obstructive pulmonary disease (COPD), post-acute sequelae of SARS-CoV-2 (long COVID), constrictive bronchiolitis, and chronic lung allograft dysfunction (CLAD) following lung transplantation. These conditions can impair quality of life and are often difficult to characterise with standard imaging tools. Early and accurate detection of ventilation abnormalities can inform clinical management.
- What the asset is trying to do
- XV LVAS (X-ray Velocimetry Lung Ventilation Analysis Software) is a software-based diagnostic device that analyses standard fluoroscopic (X-ray) chest imaging to map regional lung ventilation. Unlike nuclear medicine ventilation scans, which require inhaled radioactive tracers, XV LVAS processes motion from routine fluoroscopy images to generate a functional ventilation map (per NCT04892719 and NCT04489758 intervention descriptions). The approach does not introduce a new therapeutic agent; it provides a diagnostic readout from existing imaging infrastructure.
- What the trial is measuring, and why it matters
- The active trial (NCT05866952) is studying ventilatory and perfusion abnormalities in individuals with post-acute sequelae of SARS-CoV-2 infection, using computed tomography of the chest alongside ventilation analysis, with a primary completion date of 2026-05-31 (per ClinicalTrials.gov NCT05866952). A completed trial (NCT04489758) assessed the device for diagnosis of constrictive bronchiolitis, and a second completed trial (NCT04892719) examined its use in diagnosing CLAD after lung transplantation (per ClinicalTrials.gov NCT04489758 and NCT04892719). A further trial in mild-to-moderate COPD (NCT04880551) has an unknown status as of the registry (per ClinicalTrials.gov NCT04880551). These trials measure the device's ability to detect and characterise regional ventilation abnormalities, which matters because accurate functional imaging can distinguish disease subtypes and monitor progression.
- Efficacy benchmarks in this setting
- For lung ventilation imaging, the established reference standard in nuclear medicine is the ventilation-perfusion (V/Q) scintigraphy scan, and high-resolution computed tomography (HRCT) is widely used to assess structural lung disease. Specific sensitivity and specificity benchmarks for V/Q scintigraphy and HRCT in settings such as CLAD diagnosis and constrictive bronchiolitis vary across published studies; the relevant comparators and their diagnostic accuracy figures in these specific settings are with citations. Because the completed trials of XV LVAS enrolled small numbers of participants (18 patients each per NCT04489758 and NCT04892719), any diagnostic performance figures from those studies are not statistically comparable to established reference standards evaluated in larger populations.
- Commercial context
- 4DMedical announced that the Therapeutic Goods Administration (TGA) granted approval for a related product, CTVQ, in Australia (per ASX announcement 2026-06-25). XV LVAS has previously received clearance from the US Food and Drug Administration; the specific FDA clearance details and date are . On 2026-05-31, 4DMedical announced the acquisition of contextflow, described as creating a European Union platform (per ASX announcement 2026-05-31). Whether XV LVAS is the company's lead commercial asset, and disclosed deal or revenue terms, are .