Category: News

08 Sep 2017

4Dx assigned Intellectual Property relating to core 4Dx technology

4Dx is pleased to announce that key intellectual property relating to the Company’s 4DxV technology has been assigned from Monash University to 4Dx Limited.

The intellectual property (IP) was developed by 4Dx Chairman and CEO, Andreas Fouras, while working at Monash University and was previously licenced by 4Dx from Monash University. After reaching an investment milestone in the licence agreement between 4Dx Limited and Monash University, Monash University assigned the IP to 4Dx Limited on 1 September 2017. The assigned IP includes nine granted patents and eight patent applications across jurisdictions such as the United States of America, Europe, Australia, Japan, Singapore, Canada, India and New Zealand.

4Dx will now begin the process of having the patents and patent applications amended to list 4Dx Limited as the patentee/applicant.

28 Aug 2017

FDA Update & Future Plans

Earlier this year, 4Dx delivered a 510(k) submission to the FDA for clearance of its 4DxV technology in the radiotherapy setting. Following that submission, the FDA responded with a Request for Additional Information. To clarify the FDA’s request, 4Dx sought and gained a meeting with the FDA. While the FDA identified a potential pathway for success regarding the application, it is clear that significant time and resources would be required.

Through the meeting with the FDA, and further discussions with our regulatory consultants, 4Dx has chosen to take a more streamlined approach in taking its technology to market. This will involve progressing directly with an application for products in the Company’s core target market – the respiratory diagnostics space.  To fully focus on this plan, 4Dx has decided to withdraw the current application.

4Dx will focus efforts on this plan to gain clearance for its core product by capitalising on the open dialogue we have with the FDA about the core product’s development. The Company expects to be in a position to present a plan to the FDA in late 2017 and will report back to shareholders in early 2018 with an update.

In forming this strategy, 4Dx sought to increase its access to regulatory expertise beyond our regulatory consultant and FDA agent, Emergo. 4Dx is pleased to announce that Brian Bollwage, a regulatory strategy veteran with nearly 40 years of experience working with the FDA, is now assisting 4Dx in this important area.

In parallel with its regulatory efforts, 4Dx continues to make strong progress in building revenue opportunities, particulalry in business to business market sectors where regulatory clearance is not required.

20 Apr 2017

4Dx Preclinical Scanner Project to Rapidly Manufacture 2 Preclinical Scanner Units for Delivery in Major US Hospitals

Melbourne, Australia, 19 April 2017: 4Dx  Group “4Dx”, Hydrix Pty Ltd “Hydrix”, and Monash University are collaborating “4Dx Pre-Clinical Scanner Project consortium” to rapidly manufacture two pre-clinical scanners for delivery to two major American medical research hospitals by the end of the year. A further three units will be supplied to other world leading hospitals by the end of the 2018.

This project will deliver technology that is a world first in innovative respiratory analysis and diagnostic systems. 4Dx provides a unique 4-Dimensional perspective and expert analysis of data to clinical practitioners.  The technology results in lower costs, provides more information and faster validation of treatment with reduced radiation exposure, while also allowing for earlier detection of disease and intervention by doctors. The technology enables clinicians to capture images that effectively provide highly detailed footage of the motion and airflow within breathing lungs.

162 million respiratory diagnostic procedures are performed within the OECD each year, at a cost in excess of AU$25 billion per annum. A share of this market will create a new multi-billion-dollar industry in Victoria. This industry will see the creation of highly skilled jobs in design, engineering, software development, R&D and clinical trials in the Victorian economy.

4Dx technologies are globally unique and with strong interest from a number of major US hospitals 4Dx has the opportunity to secure a strong share of the US respiratory health clinical technology market. The technology opens up a new niche for the export of high value advanced technology manufactured in Victoria.

This innovative diagnostic was developed through research programs conducted at Monash University, with support and funding from a number of Australian and American government agencies and peak body groups.

Monash University Deputy Vice-Chancellor and Vice President (Enterprise) Mr Ken Sloan says, “the technology provides an enormous opportunity to impact global health and is a brilliant example of the leading role Monash University research teams are playing in world class innovation. By harnessing our leading research capability and driving government and commercial partnerships, Monash enterprise is tackling real world, high impact challenges, while also advancing economic growth.”

The approval process for clinical human use will be undertaken in conjunction with the utilisation of the pre-clinical scanning technology on small animals at US medical research hospitals. The partnership with major US hospitals to take up the clinical scanner technology will enable human clinical use in key facilities with a view to rapid global adoption of the technology.

4Dx CEO and founder Andreas Fouras says, “having these key US hospitals commit to a 4Dx scanner demonstrates their confidence in our technology and lays the foundations for the introduction of human research scanners in the near future.”

The Pre-Clinical Scanner Project is supported by the Victorian Government, with the project expected to create 56 new jobs and generate at least AU$6.7 million export revenue over the two year period. The consortium will directly co-invest $1.395 million in the project, with 4Dx committing to an additional $6.85 million investment into research and development operations in Victoria.

Hydrix Business Development Manager Paul Carboon says, “we are excited to support 4Dx in the design finalisation and assembly of the first batch of preclinical scanners. It is a great Victorian success story of technology that was created at Monash and is now being commercialised by 4Dx. This project leverages Hydrix’s significant experience in the development and commercialisation of x-ray based innovative products targeted at the Global Markets. It is fantastic to be able to secure the development and manufacturing of these products here in Victoria.”

4Dx CEO and founder Andreas Fouras also says, “4Dx envisages this project will provide a significant new advanced manufacturing, export and jobs opportunity for Victoria from what will be rapid global demand for disruptive 4Dx research and clinical technologies.”

Gaining Victorian Government funding support under the Future Industries Fund Sector Growth Program is vital to ensure the consortium is able to provide certainty to manufacture in Victoria and supply of the first two ventilator-scanner units to US research hospitals by the end of the year.

Minister for Industry and Employment, Wade Noonan says “through the Sector Growth Program, the Victorian Government is making it possible for innovative organisations such as 4DX Limited, Hydrix Pty Ltd and Monash University to undertake this ground breaking project which will improve the management of respiratory conditions.”   

17 Mar 2017

4Dx visits London, participates in House of Lords event

4Dx is pleased to inform you that our Chairman and CEO, Andreas Fouras, will be lead speaker at a lunchtime debate at the All Party Parliamentary Engineering Group ‘APPEG’ in the House of Lords, London on Tuesday 21st March.  The debate series represents a plank of the APPEG program to enable contact and involvement between parliamentarians and the engineering profession.

Professor the Lord Broers, Co-Chair of the Group, will introduce the debate on exciting advances in medical imaging.  “We are delighted to have Professor Fouras, Chairman and CEO of medical technology company 4Dx who founded this life-changing medical technology company, which aims to augment the capabilities of respiratory diagnostics currently available, leveraging information that has until now remained hidden in X-ray images.”

4Dx Executive Director, Steve Peuschel, is currently in London with Andreas as part of a global 4Dx roadshow presenting data from the first 4Dx in-human study to a wide range of organizations key to the company’s strategy.  This included a presentation by Andreas at the International Imaging workshop at the University of Pennsylvania in the United States.  Steve was excited by feedback from the world leaders in lung imaging.  “The response to our presentations in Philadelphia was incredibly positive.”

In addition, the company delivered presentations in Washington DC to the Cystic Fibrosis Foundation – the U.S. peak body for Cystic Fibrosis research.  The 4Dx roadshow now continues in Europe with industry and potential hospital partners, a key focus of the latter half of the trip.

19 Feb 2017


Melbourne, Australia, 20 February, 2017: Dr. Andreas Fouras, founder and CEO of medical technology company 4Dx Limited, will present preliminary clinical data at the prestigious World Lung Imaging Workshop on the 2nd of March at the University of Pennsylvania.

The software technology developed by 4Dx provides richer information, allowing for earlier detection of respiratory related disease.  Dr. Fouras, who founded the company in 2012, says that “presenting the first 4Dx in human clinical data is a great milestone for the company and we are excited to share these results to many of the world’s leading lung imaging experts at such a prestigious event”.

4Dx technology enables clinicians to capture images that effectively visualise and quantify motion of airflow at high resolution within the breathing lungs.  Currently more than 162 million respiratory diagnostic procedures are performed each year, at a cost of $25 billion per annum.

4Dx limited currently has a range of formal engagements with some of the leading institutions across the United States and is moving rapidly towards a commercial product in the United States by 2018.

09 Feb 2017

NEW STAFF APPOINTMENT: KAREN SIU, PhD- Programme Manager- Medical Device Development

Dr Karen Siu obtained her PhD from Monash University in 2003 in X-ray Physics. Her postdoctoral work as an Australian Synchrotron Research Program Fellow allowed her to explore the applications of synchrotrons, or highly intense x-ray sources, to biomedical research studying cancers of the brain and breast. She focussed on synchrotron imaging for understanding the origins and development of lung disease, in particular cystic fibrosis and asthma. In her 11 years at Monash, she built multidisciplinary and international research collaborations to investigate novel methods of preclinical imaging and new measures of airway health- attracting significant funding for her research.

As a synchrotron imaging expert, Dr Siu was a key player in early studies that demonstrated the feasibility of coupling state of the art x-ray imaging with particle imaging velocimetry (PIV) techniques from fluid mechanics. These early studies on various preclinical models built the foundations of 4Dx’s patented lung imaging technology.

Before joining 4Dx, Dr Siu was User Program Coordinator at the Australian Synchrotron, which oversaw the processes by which Australian and international researchers gain access to national research infrastructure. Coupled with her previous role as Head of X-ray Imaging at Monash Biomedical Imaging, Dr Siu brings a keen interest in research management, research infrastructure and stakeholder engagement to her new role at 4Dx.

Dr Siu will oversee the company’s first FDA Premarket Notification for 4Dx’s radiotherapy devices. Successful clearance of this device will allow the company to commercially market, a key milestone for this product and for the company’s product line. Dr Siu says, “I am excited to be joining 4Dx at a time when the company is growing and maturing rapidly. It’s a thrill to be a part of the evolution of a research idea into a marketable product that will change lives”.

22 Nov 2016

4Dx To Close Series A Capital Raise

Melbourne, Australia, November 23, 2016: 4Dx Limited is pleased to announce that, due to an overwhelming response, as of 5pm, Friday, 9th December, 2016, the company’s $4m Series A capital round will be officially closed.

It is anticipated that the round will close oversubscribed.

4Dx founder and Chairman, Andreas Fouras, said, “4Dx is extremely pleased with the response to our capital raise. The domestic investment community has demonstrated a deep understanding of our proposition, and the value inherent in it.”

“We believe this result indicates a very clear acceptance of the need for 21st century diagnostic technology in the medical marketplace. The enthusiastic reception 4Dx has received delivers 4Dx a broad base of investors and makes us highly optimistic about the prospects of a second round of capital raising in early 2017.”

4Dx has invented a four-dimensional, non-invasive, software-based imaging technology that maps regional lung motion and air flow as the lungs breathe.

The capital round places a valuation of $36m on 4Dx Limited.

Funds from the Series A investment round will be used to take the company’s first software product to market, including clinical studies to further validate the product, as well as the development and submission of its first application for U.S. Food and Drug Administration (FDA) clearance.

The respiratory diagnostic sector represents a global market of over US$25 billion per annum, and 4Dx has a clear plan to address this market, building the company one product at a time.

The 4Dx technology has been extensively patented, with core patents granted in key jurisdictions including the US and Australia. It has been proven through published preclinical studies over the past 10 years.


14 Nov 2016



4Dx was featured in an article in Australias national daily newspaper, The Australian today. Andreas Fouras, Founder and CEO of 4Dx is interviewed and the article discusses the new software for imaging lung function devised by 4Dx.


A “dream job” studying airflow through jet engines has led to an innovative lung imaging system that Professor Andreas Fouras is convinced will disrupt a $25 billion a year global industry and dramatically change healthcare outcomes.

The Australian father of five, who has relocated his family to Los Angeles to progress his venture, says he has found his opportunity to make a difference. With his team at 4DX, he has devised a new way of imaging the lungs by showing in real-time motion how air flows through them, pinpointing the areas that aren’t working well and those that are.

Professor Fouras says given the best technology for imaging the lungs is 50 years old, his innovation, which relies on computer software and four-dimensional imaging technology, is the next generation of care.

“We take X-rays of your lungs and look at how all individual parts are moving in very subtle detail with very sophisticated mathematics, which allows us to see accurately in fine detail how the air is moving through every part of the lung,” the 42-year-old says. “It gives clear insight into the trouble areas.”

A patient gets an X-ray — the X-ray machine would be used slightly different to how it is used now — and it is sent to the 4DX analysis cloud, which picks up every deficit in lung function. A detailed report is then sent back to the doctor.

Fouras initially took his mortgage to the maximum to start his company, 4DX, and later sold his house to pour every last penny he had into his new dream job.

“We are definitely on to something. 4DX is going to change healthcare globally — I’m convinced of that,” he says. Fouras says he had worked his way up the ranks at Monash University to build what he thought at that time was his dream career as a researcher, working on “fantastic” technology.

“While I was excited intellectually by the research, I wasn’t excited by the outcomes of, say, reducing drag on an aircraft by 1 per cent,” he says. “I realised that the mathematical discoveries I’d made could be useful in helping make better-informed decisions in healthcare and impact on people’s life.

So I pivoted my career down that path, and while it’s fairly common overseas, I think I’m a little bit of a trailblazer in Australia in terms of an engineer working completely in healthcare research.

“Initially it was bittersweet leaving a dream career behind but as a researcher, inventor and now a CEO, there is that common thread of ‘I’m just looking to make the world a better place through good ideas’.”

Lung diagnostics mostly relies on historic procedures. The most commonly used procedure is the pulmonary function test, which was designed in the 1860s. Then there are chest X-rays, which were developed in the 1890s, and the CT from the 1970s. “They are the mainstay of lung diagnostics and the best-case scenario is you are relying on technology that is almost 50 years old,” Fouras says.

There are 72 million lung diagnostic procedures performed in the US each year and about five million to 10 million scans per year in Australia. “All of those people are getting sub-quality information,” Fouras says. “Diseases are getting picked up later than they should, bad treatments aren’t being stopped right away and millions of people are having horrible health outcomes, or worse, dying, as a result of that.”

4DX is in the process of getting regulatory approvals and expects US support early next year. Scans using the technology are already being done in clinical trials in several hospitals in the US and Australia.

Fouras says while 4DX would remain an Australian company, he has moved its corporate headquarters to the US, given that is where the key market is. The professor says the movement in Australia to support innovation appears to be in the right direction but he says there are some zeros missing from the scale at which that movement is being proposed.

“Over the last 10 years, if you aggregate it, there have been significant cuts to the innovation budget. Any small increases proposed by the current government don’t get us back to where we were five to 10 years ago.”

His company has raised $5m and Fouras expects to reach $7m by year-end. “We have done well out of the Australian market but it took about 10 times more effort and three times longer than what it would’ve taken overseas.”

21 Sep 2016

Appointment of General Manager – Notting Hill Devices

4Dx is excited to announce that Paul Cooke will be taking on the role of General Manager of 4Dx’s specialist hardware subsidiary, Notting Hill Devices. As Paul moves into this role, he will be stepping aside from his role as Non-Executive Director, effective 1st September. During his tenure as Non-Executive Director, Paul played a key role in lifting 4Dx’s profile during our recent capital raising endeavours.


12 Sep 2016

Monash license agreement changes

Monash University

A number of positive changes have been made to the key licence agreement with Monash University (which grants 4Dx rights to commercialise this technology in exchange for royalty payments).

Most notable among these changes is that the funding threshold for assignment of patents has been lowered to A$6.5 million from A$10 million. Once this lower threshold has been met, all of these patents will be permanently and irrevocably handed over to 4Dx – the royalty, however, will remain.

Other changes reduce restrictions for 4Dx to sub-license the technology to other companies.