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.
Large market being targeted
4DMedical said in a statement to the ASX that CLEAR â contrast-free lung evaluation for acute risk in pulmonary embolism â 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 â 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 3â10%, 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 â the largest teaching hospital of Harvard Medical School â to conduct the CLEAR program.
This will compare CT:VQ head to head with CTPA.
4DMedical is valued at $2.43 billion.
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Motley Fool contributor Cameron England has no position in any of the stocks mentioned. The Motley Fool Australia’s parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.