29 October 2019
Melbourne, Australia, 29 October 2019
Australian medical technology company 4Dx Limited has attained excellent results in a major clinical trial of its patented four-dimensional lung imaging technology.
The confirmatory clinical trial showed that XV Technology™ gave clinicians much more detailed information than the commonly used pulmonary function test (PFT) and computed tomography (CT) imaging methods, confirming peer-reviewed preclinical evidence that the unique and non-invasive XV Technology™ enables unprecedented insight into pulmonary function, which is critical in the analysis and treatment of respiratory diseases such as COPD, Asthma and Cystic Fibrosis.
The trial examined whether clinical data generated using XV was consistent with current ‘gold-standard’ measures and other clinically available measures; and whether XV was more predictive than other measures in assessing changes to lung function, such as the onset of off-target effects of treatment.
The trial was conducted on patients undergoing treatment for cancer. XV scans were acquired, in combination with PFT, CT and other diagnostics, over a 13-month period following admission.
XV Technology™ showed excellent reliability and repeatability, and demonstrated good correlation with the standard of care tests, PFT and CT. Results showed that XV was superior in detecting and locating loss of lung function either as a result of disease or off target effects of treatment.
The trial showed that XV can be used to identify subtle changes not reflected in PFT data, and delivers increased predictive power and greater certainty than PFT testing through increased sensitivity and richer data.
In an expert clinical panel convened to review XV Technology™ and the results of the trial, clinicians unanimously agreed that the XV report data was “clinically meaningful,” and more so, in fact, than CT or PFT data.
The clinical trial results will be incorporated into 4Dx’s 510(k) application to the United States Food & Drug Administration (FDA) for clearance to market a medical device, which 4Dx expects to lodge by the end of 2019. 4Dx submitted a pre-submission enquiry with the FDA for XV in 2018.
Rudi Michelson, Monsoon Communications
Mobile (+61) 411 402 737
4Dx is a software company aiming to deliver the global gold standard in respiratory diagnostics for all lung disorders, including, asthma, chronic obstructive pulmonary disease (COPD), cystic fibrosis and cancer.
The unique 4Dx technology accurately and quickly scans lung function as the patient breathes, to provide sensitive, early diagnosis and to monitor changes over time. Our Software-as-a-Service (SaaS) scans deliver much more complete results, showing the subtlest variations in lung function down to the finest details, using lower levels of radiation than traditional methods.
Respiratory diagnosis is a $30 billion per annum global industry that 4Dx aims to disrupt and grow through technology that provides clinicians with greater insights into diseases of the lung. 4Dx will bring about a step change in lung health by providing better information to doctors and patients.
Better information means better decisions, and better outcomes.
Level 1, 121 Flinders Lane
Melbourne VIC 3000
Ph: 03 9620 3333