4DMedical has achieved CE Mark certification for its groundbreaking CT:VQ™ ventilation-perfusion imaging technology, unlocking the vast European market. The company also raised $83 million to fund rapid expansion across the EU.
- CT:VQ™ receives CE Mark, enabling commercial use across the European Union
- $83 million private placement completed at $5.90 per share to fund EU expansion
- Placement represents 2.45% increase in shares on issue and a 6.1% discount to last close
- CT:VQ™ already deployed at six leading U.S. academic medical centres
- Proforma cash balance of $289 million as of December 2025 supports growth plans
A Regulatory Breakthrough Opens Europe
4DMedical Limited (ASX:4DX) has reached a pivotal milestone with its CT:VQ™ technology securing CE Mark certification, allowing immediate commercial deployment across the European Union. This regulatory approval is a significant endorsement for the world’s first non-contrast, CT-based ventilation-perfusion imaging solution, positioning 4DMedical to tap into one of the largest and most sophisticated respiratory imaging markets globally.
The European Union, with its population exceeding 450 million and extensive hospital imaging infrastructure, represents a substantial opportunity. CT imaging dominates diagnostic workflows in Europe, yet traditional nuclear ventilation-perfusion scans face challenges such as limited radiotracer availability and operational complexity. CT:VQ™ addresses these issues by providing quantitative lung function insights from routine CT scans without the need for radiotracers, simplifying access and potentially improving patient outcomes.
Capital Raised to Fuel Expansion
Coinciding with the CE Mark announcement, 4DMedical completed an $83 million private placement at $5.90 per share, a price reflecting a modest discount to the last closing price but a premium to recent trading averages. This capital injection will underpin the commercial launch and scaling of CT:VQ™ across Europe, support clinical integration efforts, and maintain a robust balance sheet to pursue strategic growth opportunities, including acquisitions.
The placement will increase the company’s shares on issue by approximately 2.45%, with settlement expected in early April 2026. Bell Potter Securities Limited acted as lead manager and bookrunner, highlighting strong institutional demand for exposure to 4DMedical’s innovative respiratory imaging platform.
Building on U.S. Momentum
CT:VQ™ is already gaining traction in the United States, deployed at six leading academic medical centres including Stanford, Cleveland Clinic, and Mayo Clinic. The combination of FDA clearance and now CE Mark certification equips 4DMedical with regulatory approval in two of the world’s largest healthcare markets, setting the stage for rapid international commercialisation.
Managing Director and CEO Andreas Fouras emphasised the universal clinical need for CT:VQ™, noting the limitations of nuclear VQ scanning are common across healthcare systems. The European market alone performs an estimated 400,000 nuclear VQ scans annually, underscoring the immediate potential for CT:VQ™ adoption.
Strategic Outlook
Beyond direct sales, Europe’s role as a hub for respiratory research and clinical leadership offers 4DMedical a platform to influence global practice standards and collaborate with key opinion leaders. The company plans to leverage this regulatory milestone and capital raise to accelerate clinical adoption, expand partnerships, and enhance its evidence base.
While specific commercial launch timelines and customer agreements in Europe remain forthcoming, the company’s strong cash position of $289 million as of December 2025 provides a solid foundation for executing its growth strategy.
Bottom Line?
With regulatory clearance and fresh capital in hand, 4DMedical is poised to transform respiratory imaging across Europe; next steps will reveal how swiftly it can convert opportunity into market share.
Questions in the middle?
- How quickly will 4DMedical secure contracts with major European hospital networks?
- What reimbursement pathways will support CT:VQ™ adoption across diverse EU healthcare systems?
- Could competitive technologies or regulatory hurdles slow CT:VQ™’s European rollout?