22 May Biotech Daily – May 21
4D MEDICAL (FORMERLY 4DX)
Melbourne’s 4D says the US Food and Drug Administration has cleared its “four-dimensional” XV lung ventilation analysis software imaging product for sale in the US.
4D said that the XV technology was not intended to replace primary diagnostic tests, such as the molecular tests to prove the presence of Covid-19, but was “designed to provide … quantitative support for diagnosis and follow-up examinations”.
4D chief executive officer Dr Andreas Fouras said the XV technology provided “critical information about the functional state of a patient’s lungs in the treatment of all illnesses of the lungs, such as asthma, emphysema, pulmonary fibrosis and lung cancer”.
“In the case of Covid-19, XV can be used to triage patients into the right treatment setting and to quickly determine how well a treatment is working,” Dr Fouras said.
4D said the XV could be implemented immediately, using existing hospital and clinical infrastructure with no capital expenditure or training required.
The company said that the XV was provided as a software-as-a-service diagnostic tool, available through an internet “cloud” subscription.
4D said that imaging departments conduct an X-ray sequence using existing fluoroscopy equipment and the software “rapidly and automatically analyzes and applies its proprietary algorithms to identify and quantify any functional impairment”.
The company said that the XV lung ventilation analysis software generated a Ventilation Report which was sent to the hospital to enable clinicians to determine the most effective treatment course of action and allocation of finite hospital resources.
4D said the end-to-end process could be completed and generate a report in three hours.
“The clinical trials and peer reviews that have been undertaken over the past 15 years in conjunction with the FDA’s 510(k) clearance, provide a solid foundation for 4D Medical to obtain regulatory approval to offer its XV technology in other geographic markets such as Australia, Europe and Asia,” Dr Fouras said.
4D said it began the Australian Therapeutic Goods Administration approval process in January 2020 and had partnerships with medical researchers and hospitals in Australia for clinical trials of the XV technology.
Dr Fouras told Biotech Daily that 4D had “a small US sales team and we are increasing it as we speak”.
“We want to build the evidence and data and then make a decision on partnering for distribution,” Dr Fouras said. “It is quite likely we will keep it in-house.”
Last year, the then 4Dx said it had raised $15 million in a pre-initial public offer and intended to conduct an initial public offer within 12 months (BD: Dec 10, 2019).
4D is a public unlisted company.