• 4DMedical files FDA 510(k) submission for CT:VQ™, a non-contrast CT-based lung imaging software
• CT:VQ™ represents a revolution in ventilation perfusion imaging, solving key clinical and logistical limitations
• Compelling clinical validation package, demonstrating equivalence (or superiority) to SPECT ventilation perfusion

4DMedical Limited (ASX: 4DX), a global leader in respiratory imaging technology, has announced that it has received an acknowledgement letter from the U.S. Food and Drug Administration (FDA) confirming the filing of an FDA 510(k) submission for CT:VQ™. CT:VQ™ represents a revolution in ventilation perfusion imaging, enabling quantitative VQ data and visualisations to be extracted from a routine CT scan, without the need for any radiotracer or contrast agent. It achieves this by measuring both the regional motion and local density changes of lung tissue. CT:VQ™ solves key clinical and logistical limitations across all forms of nuclear VQ imaging, including no radiotracers, simplified workflows, higher resolution and quantification without artifacts, and leveraging the large installed base of CT scanners. Over one million nuclear VQ scans are performed annually in the U.S. alone, with an average reimbursement rate of approximately USD $1,150 per scan. 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 submission follows extensive technical development, internal validation, and regulatory documentation, and includes a comprehensive validation package that demonstrates the equivalence (or superiority) of CT:VQ™ to SPECT ventilation perfusion across multiple lung conditions. 4DMedical expects to receive FDA clearance within the average 120-day timeline for 510(k) decisions.

4DMedical believes CT:VQ™ has the potential to completely transform how respiratory disease is diagnosed and managed, offering clinicians a faster, more convenient, and more accessible tool for functional lung assessment. The company expects CT:VQ™ to rapidly disrupt the existing market and even grow clinician demand for complete functional lung imaging in other patient populations.