4DMedical (4DX) Status Update summary

Market Opportunity and Product Positioning

• Targets the multi-billion dollar global nuclear VQ imaging market, aiming to displace over one million annual scans in the US, representing a $1.1B addressable market.

• Leverages existing CT infrastructure and ~14,500 installed CT scanners in the US, expanding access to rural and smaller facilities.

• Eliminates the need for radioactive materials and contrast injections, improving patient experience and workflow.

• Product aligns with a $650 CPT code, supporting strong reimbursement incentives for adoption.

• Partnership with Philips expands sales coverage by 25 times, enhancing market reach.

Clinical Validation and Regulatory Progress

• Multicenter clinical studies demonstrated strong equivalence or superiority between CTVQ/CT:VQ™ and SPECT VQ, with r=0.872 for ventilation and r=0.842 for perfusion.

• Reader studies with experienced clinicians showed very strong agreement (Kendall's tau > 0.71), exceeding FDA targets.

• Data showed lower noise, fewer artifacts, and higher spatial resolution compared to SPECT, with higher correlation to physiological measures like DLCO.

• FDA 510(k) submission acknowledged; review process averages 90-112 days, leveraging CT LVAS™ as the predicate device.

• Commercial contracts in place for clinical trials at major U.S. medical centers.

Adoption Drivers and Customer Feedback

• Doctors report workflow bottlenecks and limited access to nuclear VQ, viewing CTVQ/CT:VQ™ as a superior, more convenient alternative.

• Can be added to routine CT scans, reducing delays and improving care delivery without additional infrastructure.

• Leading clinicians and early adopters express strong support, citing improved efficiency, data quality, and diagnostic benefits.

• Over 360 sites already deliver the technology, with revenue and customer base growing quarter on quarter.

• Positive feedback received at ATS 2025 and from leading pulmonary specialists.