Medical imaging technology company 4DMedical (ASX:4DX) has announced the first clinical pilot for its XV Lung Ventilation Analysis Software will be conducted at St Joseph Hospital located in California.
The company said the clinical pilot represents the first clinical usage of its XV LVAS on patients in the US and will be used to aid hospital physicians to screen for a variety of lung conditions, including asthma, emphysema, pulmonary fibrosis, lung cancer and COVID-19.
St Joseph Hospital will conduct a full review of XV LVAS over the coming months.
The clinical pilot signifies the commencement of 4DMedical's commercialisation phase in the US. It follows XV LVAS receiving FDA 510(k) clearance in May 2020 and Class 1 regulatory approval from the Australian TGA in September 2020.
The company said clinical pilots will form an important part of the commercial rollout of XV LVAS.
XV LVAS is designed to support the capacity of physicians to diagnose and treat patients with respiratory diseases more efficiently, by providing objective measurements of regional lung motion and airflow.
According to Andreas Fouras, founder and CEO of 4DMedical, “We are extremely pleased to announce the commencement of the clinical pilot in collaboration with St. Joseph Hospital as it signifies the commencement of our commercialisation phase in the U.S. We believe that XV LVAS is a unique tool that can assist physicians in diagnosing and managing patients with various lung diseases, including COVID-19, as it provides physicians with a unique picture of how air moves in the lungs.
“We have been extremely pleased with the feedback received from leading hospitals and clinics in the U.S., our priority market, and remain focused on continuing to progress the commercial rollout of XV LVAS.”