• Canadian regulatory approval granted for CT LVAS
• Adds to existing Canadian approvals for Pulmonary Structure portfolio products
• Increases 4DMedical's access to the large and valuable Canadian healthcare market

4DMedical Limited, a respiratory imaging technology company, has announced that it has received regulatory approval for its CT Lung Ventilation Analysis Software (CT LVAS) in Canada. The Medical Device Licence has been granted by the Health Canada Medical Devices Directorate in accordance with the Medical Devices Regulations, Section 36, as a Class 2 medical device. The approval of CT LVAS in Canada adds to the existing approvals for Lung Density Analysis (LDA), Lung Texture Analysis (LTA) and Lung Nodules in Canada, reinforcing 4DMedical's commitment to delivering cutting-edge respiratory imaging technology to patients and healthcare providers. Canada spends 63% more on healthcare than Australia and has a population of over 40 million people, with a GDP of over US$ 2.1 trillion, ranking 10th in the world. Within Canada, there are 560 CT scanners, predominantly located within hospitals (94%), with 12.7% of 6.4 million total CT examinations per annum relating to respiratory imaging. This significant opportunity lies within easy reach of 4DMedical's US-based sales teams, with 70% of Canada's population living below the 49th parallel and a further 20% living within 160 km of the US border.CT LVAS enables clinicians to assess lung ventilation using standard CT scans, providing valuable insights into lung function without the need for additional imaging or contrast agents. The software is designed to improve the diagnosis and monitoring of lung diseases, including chronic obstructive pulmonary disease (COPD) and other respiratory conditions, ultimately enhancing patient outcomes.

With the addition of CT LVAS to 4DMedical's portfolio of cleared products in Canada, the Company is well-positioned for the potential future approval of its CT:VQ™ imaging technology. CT:VQ™, once cleared, would further enhance diagnostic capabilities by integrating ventilation and perfusion imaging for a more comprehensive assessment of lung function. The Company will continue to pursue regulatory approvals in Canada as part of its strategy to drive commercial adoption and improve respiratory care across North America.