4DMedical Limited’s half-year report reveals rapid commercial traction following FDA clearance of its CT:VQ™ imaging technology, alongside a $150 million institutional placement that bolsters its cash reserves for global expansion.
- FDA clearance and CMS reimbursement secured for CT:VQ™
- 43% growth in global SaaS delivery sites to 430 locations
- $150 million institutional placement completed in January 2026
- Rapid adoption by leading US academic medical centres
- Adjusted net loss improved 18% year-over-year despite statutory loss
Regulatory Milestone and Market Validation
4DMedical Limited (ASX:4DX) marked a pivotal half-year with the FDA clearance of its CT:VQ™ technology, the world’s first non-contrast, CT-based ventilation-perfusion imaging solution. This breakthrough was swiftly followed by CMS reimbursement approval at over US$650 per scan, removing a significant barrier to adoption in the US healthcare system. The technology’s ability to integrate with existing CT infrastructure and avoid radioactive tracers positions it as a disruptive alternative to traditional nuclear VQ imaging.
The clinical community’s response has been enthusiastic, with five top-tier US academic medical centres; including Stanford University and Cleveland Clinic; embracing CT:VQ™ within months of clearance. These early adopters serve as influential reference sites, accelerating clinical validation and physician education.
Commercial Expansion and Strategic Partnerships
Commercial momentum was further amplified by a major distribution agreement with Philips, enabling access to healthcare systems across North America. Philips’ commitment to minimum revenue targets and dedicated sales resources provides 4DMedical with a robust platform for scaling adoption.
In Australia, 4DMedical advanced its footprint through a pilot agreement with Royal Melbourne Hospital, integrating its full product suite into the National Lung Cancer Screening Program. Meanwhile, a partnership with AstraZeneca expanded lung health screening initiatives across Brazil, underscoring the company’s global reach.
Financial Performance and Capital Position
Operationally, 4DMedical reported a 31% increase in underlying SaaS revenue and a 43% rise in global SaaS delivery sites to 430, reflecting strong market penetration. The number of scans performed more than doubled year-over-year to 151,905 in H1 FY26.
Despite a statutory net loss of $154 million, largely driven by non-cash accounting for a derivative financial instrument linked to its Pro Medicus loan facility, the company’s adjusted net loss improved by 18% compared to the prior period. Operating expenditure was reduced by 17%, reflecting disciplined cost management alongside strategic commercial investments.
Crucially, a $150 million institutional placement completed in January 2026 significantly strengthened 4DMedical’s balance sheet, delivering a proforma cash position exceeding $206 million. This capital injection is earmarked to accelerate CT:VQ™ commercialisation in the US, expand sales and marketing efforts, and fund ongoing research and development.
Leadership and Outlook
The appointment of Julian Sutton as Chief Financial Officer in January 2026 formalises leadership at a critical growth juncture. Sutton’s deep familiarity with the company and capital markets expertise is expected to support the next phase of commercial execution.
With regulatory approvals progressing in Canada, New Zealand, and Europe, and ongoing clinical education initiatives at major conferences, 4DMedical is well positioned to extend its global footprint. The company’s SaaS model and AI-enhanced imaging portfolio continue to redefine respiratory care diagnostics, promising to reshape clinical pathways worldwide.
Bottom Line?
4DMedical’s robust capital raise and regulatory wins set the stage for accelerated global adoption, but investors will watch closely as commercial execution scales.
Questions in the middle?
- How quickly will CT:VQ™ adoption translate into meaningful revenue growth in the US market?
- What is the timeline for securing CE marking and TGA clearance to unlock European and Australian markets?
- How will the company manage the accounting impact and market perception of its large non-cash derivative financial liability?