4DMedical (4DX) investor relations material

FDA approval and product overview

• Achieved FDA approval for CTVQ, the first non-contrast ventilation and perfusion imaging technology, marking a transformational milestone.

• CTVQ offers instant scalability with 14,500 CT scanners in the US, requiring no new infrastructure.

• Technology provides clearer, faster diagnostics, improved patient experience, and lower costs compared to nuclear VQ scans.

• Reports are integrated into existing radiology workflows, streamlining adoption for clinicians.

Market opportunity and commercial strategy

• US market opportunity estimated at $1.1 billion, with global potential of $2.6 billion.

• Commercial rollout is ready, with FDA approval as the final requirement; partnerships and direct sales channels will be used.

• Early commercial traction includes major institutions like Stanford and Brooke Army Medical Center.

• Focus is on rapid market share growth, with initial pricing around $600–$650 per procedure and a cost of delivery near $4.

Clinical validation and competitive advantages

• Clinical equivalence to SPECT VQ demonstrated through quantitative and qualitative studies, with no FDA questions on evidence.

• Superior aspects include absence of contrast artifacts, lower noise, and higher correlation with physiology.

• Technology leapfrogs outdated nuclear imaging, offering 3D imaging and better accessibility, especially in underserved areas.