How Will 4DMedical’s $10M Pro Medicus Boost Transform Lung Imaging?

Strong Financial Momentum and Strategic Capital Injection

4DMedical Limited (ASX – 4DX) has delivered a robust FY25 performance, reporting a 56% increase in operating revenue to $5.9 million, underpinned by SaaS revenue growth of 95%. This financial uplift reflects the company’s expanding footprint in respiratory imaging technology, particularly its software-as-a-service offerings that now operate at 388 global sites, a 7.5% increase quarter-on-quarter and a 60% rise year-on-year.

Crucially, 4DMedical secured a $10 million strategic investment from Pro Medicus, a global leader in medical imaging software. This capital injection is designed to accelerate commercial expansion and support the regulatory pathway for the company’s flagship CT – VQ™ product, a non-invasive lung ventilation and perfusion imaging tool. The investment structure aligns interests between both companies and offers Pro Medicus distribution rights, signaling a deepening partnership with significant growth potential.

Advancing Regulatory Milestones with CT – VQ™

In May 2025, 4DMedical filed its FDA 510(k) submission for CT – VQ™, marking a pivotal step toward regulatory clearance in the United States. The technology promises to revolutionize lung imaging by providing high-resolution functional assessments without the need for contrast agents or radiotracers, addressing longstanding clinical and logistical challenges in ventilation-perfusion imaging.

The FDA review process is progressing within expected timelines, with an average response time of approximately 112 days. Meanwhile, leading institutions such as Stanford University have adopted CT – VQ™ for research use ahead of clearance, underscoring strong clinical interest and validating the product’s potential impact on respiratory diagnostics.

Expanding Commercial Footprint and Partnerships

4DMedical’s commercial momentum is further evidenced by renewed and expanded contracts with prestigious US academic medical centers, including a three-year SaaS renewal with the University of Michigan and an enhanced agreement with Stanford University. These partnerships grant access to a comprehensive suite of lung analysis applications and position 4DMedical’s technology at the forefront of pulmonary disease diagnosis and monitoring.

Additionally, the company’s collaboration with Olympus Corporation has led to the launch of SeleCT™ Screening, a population-level emphysema screening program powered by 4DMedical’s lung density analysis technology. This initiative addresses the global underdiagnosis of chronic obstructive pulmonary disease (COPD) and expands 4DMedical’s reach into interventional respiratory care.

Further commercial traction includes a contract with Intermountain Health via Nuance Communications, integrating 4DMedical’s pulmonary hypertension analysis into a major US health system, and a new agreement with Northwell Health for lung texture analysis software, including beta testing of next-generation AI algorithms.

Operational Efficiency and Funding Outlook

Operationally, 4DMedical has improved cash flow dynamics, with a 16% reduction in net operating cash outflows quarter-on-quarter, driven by cost reduction initiatives and a leaner staff structure. The company’s proforma cash balance stood at $16.9 million as of June 30, 2025, including the Pro Medicus investment, with an expected $6 million R&D tax credit inflow forthcoming.

While the company acknowledges some consultancy cost increases related to cybersecurity and regulatory advisory services, these are modest and offset by broader savings. The management team expresses confidence in sustaining operations and achieving strategic milestones, supported by a diversified funding base and a strong pipeline of commercial contracts.

Clinical Validation and Future Prospects

4DMedical’s technologies continue to gain clinical validation, highlighted by recent independent multicenter studies demonstrating the utility of its imaging biomarkers in detecting subtle lung diseases often missed by conventional tests. The company’s XV LVAS® technology, already FDA-cleared, is poised to transform respiratory diagnostics by enabling earlier and more precise disease detection.

Looking ahead, the anticipated FDA clearance of CT – VQ™ and the ongoing expansion of commercial partnerships, including with Philips and Olympus, position 4DMedical for accelerated growth. The company’s innovative imaging solutions are set to redefine respiratory care by integrating seamlessly into existing clinical workflows and addressing significant unmet needs in lung health.