20 May Australian Financial Review: 4D Medical gets nod from FDA, pushes ahead with float plans
Written by Carrie LaFrenz, Senior Reporter
May 21, 2020 – 12.30am
Medical-technology developer 4D Medical is pushing ahead with its ASX float plans despite the market turmoil after getting the nod from the powerful US Food and Drug Administration to market its lung-imaging product.
The FDA clearance comes at a time when there is great focus on respiratory health around the world as countries deal with the COVID-19 pandemic.
Chief executive and founder Andreas Fouras is an Australian aeronautical engineer whose research into wind flow across plane wings expanded into lung health analysis technology. He moved his family to Los Angeles, where he hopes to tackle the most important healthcare market globally, where 80 million lung scans are done every year.
“We are very keen to take 4DMedical to the world, so by having the key opinion leaders and having the toughest regulator in the devices space [give us the tick], we have showed we are ready to take this to not just the US, but everywhere around the world,” he said.
There is a big opportunity with the respiratory diagnostics market valued at more than $US30 billion ($45.8 billion) a year.
“We see COVID something as additional layer, but we are not pivoting towards COVID, we are looking to cover every single lung disease,” said Mr Fouras.
Current lung-imaging techniques give an overall picture of the amount of air a lung is taking in, but 4D Medical’s technology highlights if there are parts of the lungs which are receiving less air, helping in the early diagnoses of diseases such as asthma, chronic obstructive pulmonary disease (COPD) or lung cancer. More effective treatment can then be offered to the patient.
Mr Fouras is hoping for TGA approval this year for its imaging technology, which has a three-hour turnaround from testing to diagnosis. Doctors send a lung X-ray to the company, which then runs through its software and applies algorithms to identify lung damage or reduced airflow. The hospital pays for each scan sent.
4D Medical, formerly known as 4Dx, in December raised $15 million through EL&C Baillieu. It later named Bell Potter and Evans & Partners as joint lead managers on the IPO after a scandal hit Baillieu.
It is believed that the company is seeking to raise between $30 million and $35 million this time around. Mr Fouras is predicting the company will break even by 2022 after posting an operating loss of $12 million this year.The group has already partnered with prestigious hospitals to conduct clinical trials, including LA-based Cedars Sinai Medical Centre, Cleveland Clinic and John Hopkins. Locally, it has teamed with The Telethon Kids Institute and is in talks with hospitals about partnerships, including The Alfred and The Royal in Melbourne.
Mr Fouras controls about 45 per cent of the company and has no plans to sell down in a possible float that could see his company valued at $200 million to $250 million.Other investors include CEO of Pro Medicus Dr Sam Hubert, Ryder Innovation Fund LP, Perennial Private to Public Opportunities Fund, Regal Emerging Companies Fund and Tall Oaks Asset Management.
4D Medical plans to kick off a non-deal roadshow next week to talk to fund managers. It is estimated the company will list by August.