Summary of 4DMedical (4DX) Update / Briefing September 01, 2025 Company Overview - **Company**: 4DMedical (4DX) - **Product**: CTVQ, a non-contrast ventilation and perfusion imaging technology - **FDA Approval**: Recently received FDA approval, marking a significant milestone for the company [1][15] Industry Insights - **Market Opportunity**: - The U.S. market for nuclear VQ scans is over $1.1 billion annually, with a global opportunity estimated at $2.6 billion [2] - CTVQ is expected to displace nuclear VQ scans and expand functional imaging due to its scalability and existing infrastructure [3][28] Core Technology Advantages - **No Contrast Agents**: CTVQ eliminates the need for contrast agents, providing clearer and faster diagnostics [4] - **Accessibility**: With 14,500 CT scanners in the U.S., CTVQ can be deployed without the need for new infrastructure [3][28] - **Cost Efficiency**: The technology offers lower costs of care and improved economics for healthcare providers [4][14] Clinical Validation and Performance - **Clinical Evidence**: The FDA approval was supported by robust clinical evidence, including quantitative performance assessments and qualitative evaluations by expert radiologists [16][18] - **Comparison with Existing Technologies**: CTVQ demonstrated strong agreement with SPECT VQ scans, with a statistical analysis showing high correlation [19][25] Commercial Strategy - **Market Readiness**: The company is ready for rollout following FDA approval, with established relationships and evidence to support clinical adoption [32][34] - **Partnerships**: 4DX is leveraging partnerships, including with Philips, to enhance market penetration [34][52] - **Target Hospitals**: The company has identified key hospitals with high volumes of nuclear VQ scans, such as UCSD and Cleveland Clinic, for initial commercialization efforts [35] Financial Projections - **Pricing Strategy**: Expected pricing for the CTVQ scan is around $600 per procedure, with a cost of delivery estimated at $4 [43] - **Revenue Potential**: With an annualized run rate of 300,000 scans, potential revenue could reach $300 million [49][51] Challenges and Market Dynamics - **Transition from Nuclear Medicine**: While there is strong interest, challenges include contracting and IT connectivity with existing providers [44] - **User Adoption**: The technology is designed to integrate seamlessly into existing workflows, minimizing barriers for radiologists [56] Future Outlook - **Reimbursement Timeline**: The company anticipates achieving reimbursement for CTVQ within the year, which would further accelerate market adoption [38][39] - **Global Expansion**: While focusing on the U.S. market, 4DX has ambitions for international expansion once the domestic market is established [59] Conclusion - **Strategic Positioning**: 4DMedical is well-positioned to capitalize on a significant market opportunity with its innovative CTVQ technology, aiming to improve patient outcomes and streamline healthcare processes [30][61]