4DMedical secures Australian TGA approval for XV Lung Ventilation Analysis software ahead of schedule

4DMedical ASX 4DX Lung Ventilation SaaS TGA approval FDA
4DMedical has established a sales and marketing team to begin delivering its lung ventilation software technology to Australian customers in 2021.

Another potential treatment for coronavirus patients may be available after Australia’s Therapeutic Goods Administration approved 4DMedical’s (ASX: 4DX) XV Lung Ventilation Analysis (LVA) software earlier than expected.

The software will now be included on the Australian Register of Therapeutic Goods.

Based on 4DMedical’s XV technology, LVA converts x-ray image sequences into four-dimensional quantitative data.

This enables physicians to better diagnose and treat patients with respiratory diseases by providing objective measurements of regional lung motion and airflow.

4DMedical founder and chief executive officer Andreas Fouras said the company was “extremely pleased” to secure TGA approval “ahead of schedule” enabling the technology to be offered in Australia using existing hospital equipment.

“This is an endorsement of the value of government support for Australian technology companies as we have evolved our technology that was seeded at Monash University, funded via National Health and Medical Research Council grants and spun out and subsequently raised capital from Australian investors.”

Commercialising XV LVA in Australia

Mr Fouras said he believes the company’s technology would quickly gain traction across Australia to “dramatically improve patient outcomes”.

“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 the company had established a sales and marketing team to begin delivering technology to Australian customers in 2021.

“This is significantly ahead of schedule and something we are extremely passionate about – making a difference to the Australian healthcare system where we can leverage existing equipment to dramatically improve patient outcomes.”

XV LVA technology and growth plans

Mr Fouras describes the XV LVA technology as unique and non-invasive. He added it provides doctors with “unprecedented insight” into pulmonary function.

The technology has been underpinned by 15 years’ research and development. It uses mathematical models and algorithms to convert x-ray image sequences into the four-dimensional quantitative data.

XV LVA is a SaaS offering, which 4DMedical claims can provide “immediate benefit” to Australian physicians and patients.

Today’s TGA approval news follows US Food and Drug Administration clearance in May this year.

The approvals are part of 4DMedical’s global roll-out plans for the technology.

4DMedical is an ASX newcomer after listing last month.

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