4DMedical gets US FDA green light clearance for CT-based ventilation product

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Image credit: 4DMedical's LinkedIn

Respiratory imaging technology company 4DMedical Limited announced the receipt of clearance from the US Food and Drug Administration (FDA) for its CT-based ventilation product CT LVAS.

This regulatory milestone significantly expands the accessibility of functional lung imaging in the United States, providing clinicians and patients with greater access to 4DMedical’s cutting-edge XV Technology, the ASX-listed company said in a press release.

The CT LVAS clearance follows its successful rollout in Australia, chosen as the initial market due to its high density of CT scanners per head of population.

The US boasts a substantial install base for CT scanners, with 43 scanners per million population, positioning CT LVAS to significantly broaden access to functional lung imaging for individuals in the US living with lung disease.

Last week, 4DMedical celebrated another achievement as the US Centres for Medicare & Medicaid Services (CMS) approved reimbursement for its XV LVAS product at a rate of USD 299 per procedure, effective 1 January 2024.

Following the FDA clearance for CT LVAS, the company plans to implement a similar reimbursement strategy.

It will first apply to the American Medical Association (AMA) to establish a new Category III CPT code for CT LVAS use, facilitating reimbursement by public and private health insurance schemes.

De-risking the regulatory pathway for CT:VQ, a breakthrough product in 4DMedical’s pipeline, the company released early clinical data in May.

CT:VQ combines quantitative perfusion data with ventilation data provided by CT LVAS, allowing for detailed assessments of ventilation/perfusion (V/Q) mismatch.

The technology aids in diagnosing pulmonary embolism, chronic obstructive pulmonary disease, pulmonary hypertension, and pulmonary vascular disorders.

According to the company, Acute Pulmonary Embolus (PE) diagnosis, a critical assessment of pulmonary perfusion, is currently challenging for clinicians.

Existing imaging modalities involve contrast media administration, but CT:VQ utilises non-contrast paired inspiratory-expiratory CT scans, eliminating the need for contrast agents.

The estimated market size for CT:VQ in the US is 15 per cent of the 4,000,000 annual patient procedures for Nuclear Medicine VQ assessment, offering a cost-effective alternative.

4DMedical aims to submit its CT:VQ application to the FDA by the end of 2023. With CT LVAS™ clearance, the company can use it as the predicate for CT:VQ, significantly de-risking the regulatory pathway.

The strategic timing of FDA clearance aligns with 4DMedical’s participation in the Radiological Society of North America (RSNA) Congress in Chicago, from November 26th to November 29th.

Dr Greg Mogel, MD, consultant radiologist at 4DMedical, expressed excitement, stating, “CT LVAS as an FDA-cleared product will provide my U.S. radiology colleagues immense value for their referring clinicians needing answers in chest CTs.”

4DMedical MD/CEO and Founder Andreas Fouras expressed his excitement about the progress in the commercialisation efforts.

“As we head to RSNA, I am thrilled that reimbursement has been approved for our XV LVAS product, and to now also share that we have clearance for CT LVAS in the US, which, both in their own rights, create material impetus for doctors and patients to adopt our technology. The clearance for CT LVAS offers further validation of our development and represents significant progress towards commercial release of our CT:VQ technology,” he explained.