4DMedical (4DX) investor relations material

Commercialization progress and clinical studies

• Three major announcements: CLEAR study launch, contextflow acquisition, and SimonMed contract.

• CLEAR study, led by Harvard Medical School (MGB), aims to demonstrate non-inferiority of CT:VQ versus CTPA for pulmonary embolism diagnosis, targeting a large U.S. market, with interim results to be shared before full publication.

• Study design includes patient follow-up and adjudication by a committee of doctors to validate results.

• SimonMed contract covers 170 clinics across 10 U.S. states, supporting reimbursement and Category I code pursuit.

Product and market expansion

• CT:VQ offers blood flow imaging without contrast agents, reducing risks and workflow complexity.

• Reimbursement is expected to be straightforward due to existing CPT codes and workflow benefits.

• Philips reseller agreement will benefit from a more robust product suite, supporting broader adoption.

• Veterans hospitals (VA) are showing increasing interest in adopting VQ due to better CT access.

European market entry, acquisitions, and strategic fit

• Acquisition of contextflow provides immediate European presence, sales, and regulatory teams, expanding presence to three major regions.

• contextflow brings a CE-marked lung cancer screening product, unique reimbursement contracts in Germany, and complements the existing lung imaging portfolio.

• European radiologists have shown strong interest in VQ, with the new team positioned for rapid rollout and further expansion planned.

• Lung cancer screening product has potential for expansion in Australia and the U.S., with significant market opportunity.

• Retention plans are in place to keep key contextflow staff post-acquisition, with regional leadership continuity maintained.