4DMedical (ASX:4DX) Gains Regulatory Approval for CT LVAS™ in Canada
Regulatory Approval
4DMedical Limited (ASX:4DX) has received regulatory approval from Health Canada for its CT Lung Ventilation Analysis Software (CT LVAS™) as a Class 2 medical device. This approval complements the company’s existing Canadian approvals for Lung Density Analysis (LDA), Lung Texture Analysis (LTA), and Lung Nodules, reinforcing its commitment to advanced respiratory imaging technology.
Market Opportunity
Canada’s healthcare expenditure is 63% higher than Australia’s, with a population exceeding 40 million and a GDP over US$2.1 trillion. The country has 560 CT scanners, primarily in hospitals, and respiratory imaging accounts for 12.7% of the 6.4 million annual CT examinations. This presents a significant opportunity for 4DMedical, supported by its US-based sales teams and the geographic proximity of 70% of Canada’s population to the US border.
Product Overview
CT LVAS™ enables clinicians to assess lung ventilation using standard CT scans without the need for additional imaging or contrast agents. The software enhances the diagnosis and monitoring of lung diseases, including chronic obstructive pulmonary disease (COPD), leading to improved patient outcomes.
Future Outlook
With CT LVAS™ approved in Canada, 4DMedical is well-positioned for the potential future approval of its CT:VQ™ imaging technology. CT:VQ™ aims to integrate ventilation and perfusion imaging for a more comprehensive assessment of lung function. The company will continue to pursue regulatory approvals in Canada to drive commercial adoption and advance respiratory care across North America.
Executive Comments
4DMedical MD/CEO and Founder Andreas Fouras said: “I am excited to be able to add functional imaging technology through CT LVAS™ to our structural imaging portfolio in Canada. With the vast majority of Canadians living near the north-east corner of the US and with easy travel and shared culture no region is more accessible to our US-based sales team. In the last half we grew our number of sites by 24%, scans per site at over 10% and average fee per scan by 12%. With our team having cracked the code on how to drive adoption, now is a great time to have CT:LVAS™ approved in Canada.”
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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