4DMedical Secures CE Mark and Raises $83M to Launch Lung Imaging into Europe
4DMedical secures CE Mark and launches $83 million placement to fund CT:VQ European expansion
4DMedical (ASX: 4DX) has announced CE Mark certification for its CT:VQ technology, enabling commercial deployment across the European Union. Simultaneously, the company has received firm commitments for an $83 million private placement at $5.90 per share to fund the 4DMedical CT:VQ European expansion, positioning the respiratory imaging specialist to replicate its US commercial success across a second major market with a proforma cash balance of $289 million as at 31 December 2025.
CT:VQ is the world’s first and only non-contrast, CT-based ventilation-perfusion imaging solution. The dual milestone removes both the regulatory barrier to European market access and the funding constraint that could have limited deployment speed. The placement price represented a 6.1% discount to the last closing price on 26 March 2026 and a 12.3% premium to the five-day volume-weighted average price, suggesting institutional investors viewed current valuation as an attractive entry point.
The capital raise will result in the issue of approximately 14.1 million new shares, representing dilution of 2.45%. Settlement is expected to occur on 1 April 2026, with shares expected to commence trading on 2 April 2026. Bell Potter Securities Limited acted as lead manager and bookrunner to the placement.
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What is CT:VQ and why does it matter?
Ventilation-perfusion imaging shows how air and blood flow through the lungs, helping physicians diagnose conditions such as pulmonary embolism and other cardiopulmonary disorders. Traditional nuclear VQ scans require radioactive tracers, specialist equipment, and trained nuclear medicine staff. Access to these scans remains constrained globally due to radiotracer supply chain issues, workforce limitations, and operational complexity.
CT:VQ solves this clinical bottleneck by delivering quantitative ventilation-perfusion insights from routine non-contrast CT scans, without requiring radiotracers or specialised infrastructure. The technology converts existing hospital CT scanner capacity into advanced diagnostic capability, creating a Software-as-a-Service revenue opportunity with minimal implementation friction.
For healthcare providers, CT:VQ removes dependency on radiotracer availability whilst leveraging CT infrastructure already in place across hospital networks. For 4DMedical (ASX: 4DX), the SaaS business model delivers recurring revenue as deployments scale, with high margins and no manufacturing complexity associated with hardware sales.
European market opportunity and commercial strategy
The European Union represents one of the largest global markets for advanced cardiothoracic imaging, with a population exceeding 450 million and highly developed hospital-based imaging infrastructure. An estimated 400,000 nuclear VQ scans are performed annually across the EU, yet access remains constrained in many regions due to the operational challenges of nuclear imaging.
CT is the dominant diagnostic imaging modality across European healthcare systems, supported by an extensive network of CT scanners and well-established clinical workflows. This existing infrastructure base provides immediate deployment potential for CT:VQ without requiring hospitals to invest in new capital equipment.
Beyond the direct commercial opportunity, Europe plays a critical role in shaping global clinical practice in respiratory imaging. Many of the world’s leading respiratory thought leaders, academic centres, and international congresses are based in Europe. Regulatory clearance enables 4DMedical to engage with these clinicians, support locally led research, and contribute to the global evidence base for CT:VQ.
Investment in Europe is also expected to increase visibility among US clinicians, many of whom regularly attend European congresses and collaborate closely with European research groups. This creates a flywheel effect where European adoption strengthens commercial momentum in the US market.
| Market | Population | Regulatory Status | Commercial Stage |
|---|---|---|---|
| United States | 330M+ | FDA Cleared | Six Academic Medical Centers deployed |
| European Union | 450M+ | CE Mark Certified | Commercial launch commencing |
US momentum provides the European playbook
CT:VQ is now deployed at six leading US Academic Medical Centers, providing a proven commercial playbook for European expansion. The institutions using the technology include:
- Stanford
- Cleveland Clinic
- University of Miami
- UC San Diego Health
- University of Chicago Medicine
- Mayo Clinic
The speed of US adoption since FDA clearance validates clinical demand for non-contrast CT-based ventilation-perfusion imaging. European expansion replicates this proven commercial approach rather than pioneering an uncertain strategy. With regulatory clearance now secured across both the US and EU, 4DMedical (ASX: 4DX) holds approval to commercialise CT:VQ across the world’s two largest healthcare markets.
Use of funds and strategic positioning
Proceeds from the $83 million placement will fund three primary uses. First, the capital will support the commercial launch of CT:VQ across Europe and international markets, including sales and marketing infrastructure, clinical support teams, and customer engagement programmes. Second, funds will support clinical integration for new customers as hospitals adopt the technology into existing workflows. Third, the placement strengthens the balance sheet to pursue strategic growth opportunities, including potential acquisitions.
The proforma cash position of $289 million as at 31 December 2025 provides substantial runway for European deployment without requiring further capital raising in the near term. The modest dilution of 2.45% and premium to five-day VWAP suggest institutional investors viewed the placement as an opportunity to establish positions ahead of European commercial rollout.
Andreas Fouras, MD/CEO and Founder
“This placement, timed alongside CE Mark certification, gives us the resources to carry that same momentum into Europe. The clinical need for CT:VQ is universal. The limitations of nuclear VQ scanning – radiotracer constraints, limited access, operational complexity – exist in every healthcare system. With an estimated 400,000 nuclear VQ scans performed annually across the EU, and an extensive network of CT scanners, the European opportunity is substantial and immediate. We are already developing exciting plans to deploy this capital in Europe, and we look forward to sharing those plans with you before the end of FY26.”
The strong balance sheet also provides optionality for strategic acquisitions without dilutive capital raising. Management has committed to sharing detailed European deployment plans before the end of FY26, providing visibility on how capital will be deployed to accelerate market penetration.
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What this means for the investment thesis
The 4DMedical CT:VQ European expansion announcement combines two material catalysts: regulatory clearance removes the market access barrier whilst the capital raise removes the funding constraint. CE Mark certification enables immediate commercial engagement with healthcare providers across the European Union, whilst $289 million in proforma cash provides multi-year runway and strategic flexibility.
4DMedical now holds first-mover advantage as the only provider of non-contrast, CT-based ventilation-perfusion imaging globally. The SaaS business model delivers recurring revenue as hospital deployments scale, with high margins and integration into existing CT infrastructure rather than requiring new capital equipment purchases. Regulatory clearance now extends across the US, EU, Canada, and Australia for various products within the imaging portfolio.
Five key investment takeaways emerge from the announcement:
- CE Mark certification unlocks Europe’s 450 million+ population market with immediate commercial access
- $289 million proforma cash balance provides multi-year runway and M&A optionality without near-term dilution risk
- Six premier US institutions validate the clinical adoption trajectory and provide a replicable commercial playbook
- SaaS model delivers high-margin recurring revenue as hospital deployments scale across both major markets
- First-mover status in non-contrast CT-based VQ imaging creates a structural competitive advantage globally
The announcement transforms 4DMedical (ASX: 4DX) from a US-focused commercial story to a global respiratory imaging platform with regulatory clearance across the world’s two largest healthcare markets. With $83 million in fresh capital and proven US institutional adoption, the company is positioned to execute European deployment without the financial constraints that typically limit early-stage medical technology companies expanding into new geographic markets.
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