4DMedical (ASX:4DX), a medical technology company focused on commercialising its patented respiratory imaging platform, says it has successfully recruited and scanned the first cohort of participants of its clinical trial to validate its Ventilation-Perfusion (VQ) product at the University of Miami.
The company said its VQ product is its first combination diagnostic tool that measures both airflow (ventilation) and blood flow (perfusion) in the lungs without the use of any contrast agents.
Ventilation-perfusion measurements provide valuable insights to clinicians by enabling earlier detection and intervention of lung diseases.
The commencement of recruitment and scanning follows on from Institutional Review Board (IRB) approval of the ethical design of the study.
The company said the clinical trial aims to recruit and image 70 participants over the next 6 months, comprised of patients with obstructive lung disease, restrictive lung disease and controls.
The study’s objective is to compare the data obtained from 4DMedical’s VQ scans against nuclear medicine VQ scans. Nuclear medicine VQ scans are typically completed in 1-2 hours and undertaken in two procedures.
For the perfusion scan, a technician injects a radioactive dye into a patient’s bloodstream and monitors blood flow into the lungs using a nuclear VQ scanner.
For the pulmonary ventilation scan, airflow in the lungs is measured using a second nuclear VQ scanner that images a radioactive particulate that is inhaled by the patient and deposited into the lungs. In addition to exposing patients to radioactive materials, nuclear medicine VQ scans deliver lower resolution than other medical imaging modalities and require the availability of specialised capital equipment and operators that are not available at all hospitals at all times of the day.
4DMedical said its VQ product utilises standard hospital imaging equipment with the imaging protocol designed to be completed in less than 10 minutes and without the use of any contrast agents.
4DMedical founder and CEO Andreas Fouras said, “I am extremely proud of our team’s progress towards the development of our VQ product. The recommencement of U.S. hospital workflows, following relief from the COVID-19 vaccination program, has allowed our clinical trials to recommence recruitment and scanning. The ability of 4DMedical’s VQ product to measure ventilation-perfusion without the use of any contrast agents provides compelling advantages for clinicians to perform scans more frequently and on a broader patient population.”