4DMedical (4DX) Status update summary

Clinical impact and technology overview

• CT:VQ provides non-contrast, functional lung imaging, offering both ventilation and perfusion data, which is not possible with standard anatomical CT scans.

• Enables more precise patient selection for lung volume reduction surgery (LVRS), potentially increasing surgical success rates from 46% to 76%.

• Functional imaging helps guide treatment decisions, such as surgery versus endobronchial valve placement, and allows for better monitoring of expensive therapies.

• Physicians report immediate clinical benefits and improved patient outcomes, with patients experiencing significant improvements post-surgery.

• The technology is well received by clinicians, with high interest and engagement at major conferences.

Commercial and operational developments

• High-volume centers like Duke perform up to 200 LVRS procedures annually, representing significant revenue potential.

• Adoption of CT:VQ is expected to streamline workflows, reduce reliance on nuclear medicine, and expand the pool of treatable patients.

• Partnerships with major pharmaceutical companies (e.g., GSK, AstraZeneca) are underway to support drug trials and patient selection.

• Distribution partnerships, notably with Philips, are driving sales and expanding reach into academic and VA medical centers.

• The sales pipeline is robust, with record leads and strong interest from both clinical and commercial stakeholders.

Future outlook and adoption

• Ongoing and upcoming multi-center studies aim to validate CT:VQ against CTPA for acute pulmonary embolism, with anticipated public announcements soon.

• Broader adoption is expected as more peer-reviewed publications emerge, increasing clinician confidence.

• The technology is positioned for expansion into Europe, with open doors at major London hospitals.

• Functional imaging is anticipated to become standard in monitoring chronic lung disease therapies, especially for high-cost drugs.

• The next 12 months are expected to bring significant clinical and commercial growth, with increased productivity and market penetration.