4DMedical Ltd (ASX: 4DX) has launched a new clinical program which it says is designed to fast-track its entry into the large acute pulmonary embolism market.
The company's shares jumped as high as $4.48 on the news before settling back to be 4.4% higher at $4.28.
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Large market being targeted
4DMedical said in a statement to the ASX that CLEAR – contrast-free lung evaluation for acute risk in pulmonary embolism – was a clinical evidence program designed to fast-track its entry into the acute pulmonary embolism (PE) market, which would grow the addressable market for its CT:VQ product in the US to US$3 billion.
The company said PE accounts for about 600,000 to 650,000 diagnosed clinical episodes in the US per annum, with the true number of episodes likely much higher due to under-diagnosis.
The company added:
Because PE presents with non-specific symptoms such as chest pain and shortness of breath, and carries significant morbidity and mortality if untreated, clinical pathways are intentionally biased toward exclusion rather than confirmation. As a result, imaging volumes significantly exceed disease incidence.
4DMedical said CTPA – which its product could displace – had become the de facto imaging modality for suspected PE. This procedure involves injecting a contract dye into the bloodstream and taking x-ray scans.
Scan volumes had increased four-fold over the past 20 years or so, the company said.
The company added:
This persistent overuse has been accompanied by declining diagnostic efficiency. Across large cohorts, the positive diagnostic yield of CTPA has been reported in the range of approximately 3–10%, meaning the vast majority of patients (90-97%) undergo iodinated contrast exposure without confirmation of PE. Consequently, large volumes of patients are subjected to higher-cost imaging using contrast injections to rule-out PE as part of standard emergency and acute-care workflows.
4DMedical said there were an estimated five million CTPA scans carried out for suspected PE in the US each year.
Better outcome, less impact
Its CT:VQ product could achieve the same clinical outcome with less invasive scans, the company said.
CT:VQ generates quantitative, three-dimensional ventilation and perfusion maps from routine, non-contrast inspiratory and expiratory CT scans, enabling contrast-free functional lung assessment within standard CT workflows. Importantly, the underlying VQ (ventilation and perfusion) indication is already FDA-cleared, de-risking the regulatory pathway, while CLEAR generates the clinical evidence to drive adoption in acute PE. 4DMedical is already displacing nuclear VQ at pace. The Company believes the high-quality clinical evidence from CLEAR positions CT:VQ to extend beyond that core market into the materially larger (~5 million scans per annum in the U.S.) acute PE opportunity.
4DMedical also said it had entered into a clinical research agreement with Mass General Brigham at Massachusetts General Hospital – the largest teaching hospital of Harvard Medical School – to conduct the CLEAR program.
This will compare CT:VQ head to head with CTPA.
4DMedical is valued at $2.43 billion.
