4DMedical (4DX) Investor Update summary

FDA approval and market opportunity

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

• Addressable market estimated at $1.1 billion in the U.S. and $2.6 billion globally, with over a million nuclear VQ scans performed annually in the U.S.

• CTV-Q leverages existing CT infrastructure, enabling instant scalability with 14,500 CT scanners in the U.S. and no need for new equipment.

• Technology is positioned to displace nuclear VQ scans and expand functional imaging access.

Clinical validation and workflow integration

• Clinical validation included quantitative device performance, qualitative reader assessment, and case-based review, all showing strong agreement with SPECT VQ.

• FDA clearance was granted with no questions on clinical evidence, reflecting robust data and methodology.

• Reports are integrated into existing radiology workflows, using standard protocols and customizable image layers for seamless adoption.

• No learning curve for radiologists, as images are designed to match current nuclear VQ displays.

Economic and patient benefits

• CTV-Q offers lower cost, improved workflow, and better patient experience compared to nuclear medicine, eliminating the need for radioactive materials and contrast agents.

• Enhanced accessibility, especially in rural areas, due to widespread CT availability.

• Estimated procedure price is $600–$650, with a delivery cost of about $4, allowing revenue sharing with hospitals and partners.