4DMedical gets the all-clear to roll out its lung imaging tech Down Under

4DMedical (ASX:4DX) wins approval to sell its lung imaging software in Australia
Company intends to deliver in 2021 although the US remains its primary focus
Shares up 130 per cent since listing less than two months ago

4DMedical’s (ASX:4DX) lung imaging software could soon be coming to a medical practice near you.

Australia’s medical regulator – the Therapeutic Goods Administration (TGA) – formally approved the company’s XV LVAS software for commercial sale in Australia. Specifically, it won the right of inclusion in the Australian Register of Therapeutic Goods (ARTG).

4DMedical’s technology platform, XV, helps physicians monitor lung performance and identify disorders utilising no dyes and lower radiation.

XV can help doctors follow-up COVID-19 patients in providing ventilation reports of their lung activity, however it falls short of being an alternative method of diagnosis to the molecular tests.

The XV LVAS specifically converts sequences of X-ray images into four-dimensional quantitative data.

The company obtained approval from America’s regulator, the FDA, before it even listed on the local bourse.

America is the company’s primary focus having the greatest share of the US$31 billion global respiratory diagnostic market, at 40 per cent.

Additionally it has a regulator with a reputation of being the world’s most stringent.

‘A truly exciting moment’

But with the technology having been developed in Australia, 4DMedical’s founder & CEO Andreas Fouras told shareholders it was a pleasure to offer its tech in 4D’s own backyard.

“To be able to commercialise and offer our software to the Australian market as an Australian technology story is a truly exciting moment for myself and the team,” he said.

“While the US market will continue to be our focus as the largest respiratory market, Australia is our home and we believe we can now move quickly to get traction through leveraging out hometown advantage and relationships faster than any other market.”

Fouras told Stockhead the approval was thanks to the Medical Device Single Audit Program (MDSAP) which is an quality management system allowing a single audit to satisfy multiple health regulators.

With the program’s help, his company is eyeing off further markets.

“Over time we would like to cover most of the planet,” Fouras declared.

The Australian approval came ahead of schedule and the company is preparing to sell Down Under in 2021 beginning at a pilot site.

Shares rose 11 per cent this morning and are up 130 per cent since 4DX listed in early August. It is one of the most successful ASX IPOs this year.